Latest news with #SibylleLoibl
Medscape
19-05-2025
- Health
- Medscape
Adjuvant Pertuzumab Shows OS Benefit in Breast Cancer
Adding adjuvant pertuzumab to standard adjuvant chemotherapy and trastuzumab improved overall survival at 11 years of follow-up in patients with early human epidermal growth factor receptor 2 (HER2)–positive operable breast cancer, according to a new analysis of a phase 3 trial. The benefit was driven only by those with node-positive cancer, according to findings presented by Sibylle Loibl, MD, PhD, on May 15 at ESMO Breast Cancer 2025. The results, from 11.3 years of follow-up in the final analysis from the APHINITY trial, are the first analysis to show an overall survival benefit. 'The [invasive disease-free survival] benefit was maintained, remaining clinically meaningful in the node-positive subgroup, while no benefit was observed in the node-negative subgroup,' Loibl, an associate professor of obstetrics and gynecology at the Goethe University of Frankfurt, Frankfurt, Germany, said during her presentation. In the original trial of 4805 patients with HER2-positive operable breast cancer, 2400 patients received adjuvant pertuzumab (840 mg, then 420 mg), and 2405 received placebo, both in addition to standard adjuvant chemotherapy and 1 year of treatment with trastuzumab. The patient groups were similarly balanced in terms of nodal status, adjuvant chemotherapy regimen (with or without anthracyclines), and hormone receptor status. In the 2017 analysis published in The New England Journal of Medicine , patients receiving pertuzumab had improved invasive disease-free survival (IDFS), but the benefit compared with placebo was seen only in those with node-positive disease. The third analysis with 8 years of follow-up in 2022 showed similar findings without any overall survival benefit seen in those receiving pertuzumab. In this analysis, conducted 34 months after the third previously reported analysis, there were 62 additional deaths and 73 additional IDFS events, for a total of 452 deaths and 682 IDFS events since the trial's start. Total deaths in the pertuzumab arm were 205 (8.5%) compared with 247 (10.3%) in the placebo arm, for a 1.8% absolute difference in death rate (adjusted hazard ratio [aHR], 0.83; 95% CI, 0.69-1.00; P = .441). Stratification by nodal status revealed the difference in overall survival benefit for node-positive vs node-negative disease. In node-positive patients, those receiving pertuzumab had an 89.6% survival rate compared with 86.9% in the placebo group, an absolute difference of 2.7% (unadjusted HR, 0.79; 95% CI, 0.64-0.97). In node-negative patients, however, those receiving pertuzumab had a survival rate of 94.9% compared with 94.6% with placebo (unadjusted HR, 0.99; 95% CI, 0.66-1.49). An IDFS event occurred in 12.6% of patients receiving pertuzumab vs 15.8% receiving placebo. Distant recurrence was seen in 6.3% with pertuzumab and 8.8% with placebo, and locoregional recurrence in 1.5% with pertuzumab and 2.5% with placebo. In the pertuzumab group, IDFS was 87.2% vs 83.8% with placebo (aHR, 0.79; 95% CI, 0.68-0.92), an absolute difference of 3.4%. Again, the benefit only occurred in those with node-positive disease (HR, 0.74; 95% CI, 0.62-0.88), while patients with node-negative disease saw no benefit with pertuzumab vs placebo (HR, 1.01; 95% CI, 0.74-1.38). IDFS events did not differ by hormone receptor (HR) status, with both node-positive HR+ (HR, 0.68) and node-positive HR− (HR, 0.83) patients seeing benefits. In the node-negative patients, neither those with HR+ (HR, 1.03) nor HR− (0.98) saw benefit with pertuzumab. Cardiac events were similar in the pertuzumab (0.9%) and placebo (0.5%) groups, with similar rates of cardiac death in both groups (0.1% and 0.2%, respectively) and no new cardiac safety signals. An analysis of those only receiving anthracyclines similarly showed no significant differences in cardiac events or deaths. The data from 3 years ago showing an IDFS benefit without an overall survival benefit were 'good enough to consider pertuzumab for the node-positive population,' said invited discussant Javier Cortés, MD, PhD, of the International Breast Cancer Center at Pangaea Oncology in Barcelona, the Universidad Europea de Madrid and Hospital Beata Maria Ana in Madrid, and the Medica Scientia Innovation Research, Barcelona, Spain, with Oncoclínicas & Co in Jersey City, New Jersey, and São Paulo, Brazil. The overall survival benefit seen with pertuzumab is comparable to the 2.7% absolute benefit seen with aromatase inhibitors compared with tamoxifen, he noted. Cortés said he does not think it's necessary to wait to see an overall survival benefit to give the green light to a therapy with a clear IDFS benefit. 'The question we have to ask ourselves, in my opinion, is, should we wait to see overall survival improvements when we have significant, distant, disease-free survival improvements?' Cortés told attendees. 'You maybe are not going to see the overall survival, but you may prevent metastasis, and that's something, in my opinion, that we have to consider in the early breast cancer setting,' he said. 'In early breast cancer studies, the primary point, in my opinion, should not be invasive disease-free survival.' Instead, the primary endpoint should be distant disease-free survival, and 'we should not wait for overall survival data to mature before making drug approval decisions,' he said. 'Delaying approval may result in patients progressing to metastatic disease and dying as a consequence,' he emphasized. 'Many patients will die if we are unable to use a drug because we are waiting for the approval based on the overall survival data.' Cortés also addressed the cost-effectiveness of the therapy on the basis of analysis from the United States and Spain. 'If we select the patients carefully, if we go for the highest risk group of patients, maybe the addition of pertuzumab is likely to be cost-effective,' he said. The research was funded by F. Hoffmann-La Roche Ltd in collaboration with the Breast International Group. Loibl reported royalties from VMscope and grants or honoraria from AstraZeneca, AbbVie, Agendia, Amgen, BioNTech, Celgene/BMS, Celcuity, DSI, Exact Sciences, Gilead Sciences, GSK, Incyte, Eli Lilly and Company, Molecular Health, MSD, Novartis, Pierre Fabre, Pfizer, Relay, Roche, Sanofi, Seagen, Stemline Therapeutics/Menarini, Olema, Bayer, Bicycle, Jazz Pharmaceuticals, and BeiGene, plus three planned, issued, or pending patents. Co-lead author Martine Piccart, MD, PhD, reported receiving consulting fees, advisory roles, scientific board service, or research funding from AstraZeneca, Eli Lilly and Company, MSD, Novartis, Pfizer, Menarini, Seagen, Roche/Genentech, NBE Therapeutics, Frame Therapeutics, Gilead Sciences, Radius Health, Synthon, Servier, Immunomedics/Gilead Sciences, and Oncolytics. Cortés reported stock with MAJ3 Capital and a relative's stock in Leuko and disclosures with Roche, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Eli Lilly and Company, Merck Sharp & Dohme, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, Biolnvent, GEMoaB, Gilead Sciences, Menarini, Zymeworks, Reveal Genomics, Scorpion Therapeutics, ExpreS2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, BridgeBio, BioNTech, Biocon, Novartis, Eisai, Pfizer, Stemline Therapeutics, ARIAD Pharmaceuticals, Baxalta GmbH/Servier Affaires, Bayer, Guardant Health, PIQUR Therapeutics, and IQVIA. He holds a patent for a pharmaceutical combination of a PI3K inhibitor and a microtubule-destabilizing agent and for an HER2 predictor of response.
Yahoo
13-05-2025
- Business
- Yahoo
Ten-Year APHINITY Data Show Genentech's Perjeta-based Regimen Reduced the Risk of Death by 17% in HER2-Positive Early-Stage Breast Cancer
– Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy – – 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease – – Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer Congress – SOUTH SAN FRANCISCO, Calif., May 13, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo. "Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen," said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "These long-term data reinforce the regimen's value as a well-established standard-of-care treatment in the curative setting." "After ten years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Prof. Sibylle Loibl, APHINITY study chair, chair of the German Breast Group (GBG) and the chief executive officer of the GBG Forschungs GmbH. "Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph node-positive disease who are at high risk of recurrence." After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044). A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97). The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), strengthening results from earlier APHINITY analyses. No benefit was seen in the node negative subgroup. The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified. Full results will be presented as a late-breaking abstract on Thursday, May 15 at the 2025 European Society for Medical Oncology Breast Cancer Congress. "The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings," said Liz Frank, independent research advocate. "Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring." The collaborative efforts of Genentech, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer. About the APHINITY study APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is a global, Phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer. The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment. Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life. What is Perjeta? Perjeta® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and chemotherapy for: Use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer Use after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer that has a high likelihood of coming back Perjeta® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer. Important Safety Information What are the possible side effects of Perjeta? Perjeta may cause serious side effects, including: Perjeta can cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure) Your doctor will run tests to monitor your heart function before and during treatment Based on these tests, your treatment may be interrupted or discontinued Contact a health care professional immediately if you experience any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects. Your doctor will verify your pregnancy status before treatment begins Birth control should be used while receiving Perjeta and for 7 months after your last dose of Perjeta. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping Perjeta If you think you may be pregnant, you should contact your healthcare provider immediately If you are exposed to Perjeta during pregnancy, or become pregnant while receiving Perjeta or within 7 months following the last dose of Perjeta with Herceptin, you are encouraged to report Perjeta exposure to Genentech at 1-888-835-2555 Who should not take Perjeta? Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta. What are other possible serious side effects of Perjeta? Serious side effects of Perjeta may also include: Infusion-related reactions: Perjeta is given as an infusion. Perjeta can cause serious infusion-related reactions, some fatal. When given alone, the most common infusion-related reactions were fever, chills, fatigue, headache, weakness, hypersensitivity, and vomiting. When given with Herceptin and docetaxel, the most common infusion-related reactions were fatigue, altered taste, hypersensitivity, muscle pain, and vomiting Severe allergic reactions: Perjeta can cause hypersensitivity reactions, including anaphylaxis and fatal events. Contact a health care professional immediately if you experience any of the following symptoms: swelling of the face, lips or tongue, trouble breathing, or chest pains The most common side effects of Perjeta include: The most common side effects of Perjeta when given with Herceptin and chemotherapy prior to surgery for early breast cancer include: Constipation Damage to the nerves (numbness, tingling, pain in hands/feet) Diarrhea Fatigue Hair loss Headache Decreased red blood cell counts, white blood cell counts, and platelet counts Mouth sores or blisters Nausea Muscle pain Vomiting Weakness The most common side effects of Perjeta when given with Herceptin and chemotherapy after surgery for early breast cancer include: Diarrhea Nausea Hair loss Fatigue Damage to the nerves (numbness, tingling, pain in hands/feet) Vomiting The most common side effects of Perjeta when given with Herceptin and docetaxel for metastatic breast cancer include: Diarrhea Hair loss Low levels of white blood cells with or without fever Nausea Fatigue Rash Damage to the nerves (numbness, tingling, pain in hands/feet) Side effects may vary based on chemotherapy regimen. These are not all the possible side effects of Perjeta. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Before you take Perjeta, tell your healthcare provider about all of your medical conditions, including if you: Have a history of heart disease Are pregnant or plan to become pregnant. Perjeta can harm your unborn baby Are breastfeeding or plan to breastfeed. It is not known if Perjeta passes into your breastmilk Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see the full Prescribing Information for additional Important Safety Information, including most serious side effects. What is Herceptin? Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways: As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→ TH." With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH." Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy). Patients are selected for therapy based on an FDA-approved test for Herceptin. *High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3. Important Safety Information Possible serious side effects with Herceptin Not all people have serious side effects, but side effects with Herceptin therapy are common. Although some people may have a life-threatening side effect, most do not. A patient's doctor will stop treatment if any serious side effects occur. Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following: HEART PROBLEMS These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient's doctor will check for signs of heart problems before, during, and after treatment with Herceptin. INFUSION REACTIONS, including: Fever and chills Feeling sick to your stomach (nausea) Throwing up (vomiting) Pain (in some cases at tumor sites) Headache Dizziness Shortness of breath These signs usually happen within 24 hours after receiving Herceptin. A patient should be sure to contact their doctor if they: Are a woman who could become pregnant, or may be pregnant Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and for 7 months after your last dose of Herceptin. If you are or become pregnant while receiving Herceptin or within 7 months after your last dose of Herceptin, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555. Have any signs of SEVERE LUNG PROBLEMS, including: Severe shortness of breath Fluid in or around the lungs Weakening of the valve between the heart and the lungs Not enough oxygen in the body Swelling of the lungs Scarring of the lungs A patient's doctor may check for signs of severe lung problems when he or she examines the patient. Have LOW WHITE BLOOD CELL COUNTS Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone. A patient's doctor may check for signs of low white blood cell counts when he or she examines the patient. Side effects seen most often with Herceptin Some patients receiving Herceptin for breast cancer had the following side effects: Fever Feeling sick to your stomach (nausea) Throwing up (vomiting) Infusion reactions Diarrhea Infections Increased cough Headache Feeling tired Shortness of breath Rash Low white and red blood cell counts Muscle pain A patient should contact their doctor immediately if they have any of the side effects listed above. Patients are encouraged to report side effects to Genentech and the FDA. You may report side effects to FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Please see the full Prescribing Information, including Boxed WARNINGS and additional Important Safety Information, at About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit All trademarks used or mentioned in this release are protected by law. View source version on Contacts Media Contact:Nicole Burkart, (650) 467-6800 Advocacy Contact:Julie Burns, (860) 881-6594 Investor Contacts:Loren Kalm, (650) 225-3217Bruno Eschli, +41616875284 Sign in to access your portfolio
Yahoo
13-05-2025
- Business
- Yahoo
Ten-year APHINITY data show Roche's Perjeta-based regimen reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer
Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy1 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease1 Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer Congress Basel, 13 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer.1 After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo.1 'Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen,' said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. 'These long-term data reinforce the regimen's value as a well-established standard-of-care treatment in the curative setting.' "After 10 years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Prof. Sibylle Loibl, APHINITY Study Chair, Chair of the German Breast Group (GBG) and the Chief Executive Officer of the GBG Forschungs GmbH. 'Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph-node positive disease who are at high risk of recurrence.' After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044).1 A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97).1 The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), strengthening results from earlier APHINITY analyses.1,2 No benefit was seen in the node negative subgroup.1 The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified.1,2 Full results will be presented as a late-breaking abstract on Thursday, 15 May at the 2025 European Society for Medical Oncology Breast Cancer Congress. 'The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings,' said Liz Frank, Independent Research Advocate. 'Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring.' The collaborative efforts of Roche, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer.3 About the APHINITY studyAPHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is a global, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer.4 The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment.4 Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life.4 About the Perjeta-based regimen (intravenous (IV) Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy)The Perjeta-based regimen is approved in more than 120 countries/regions for the treatment of both early-stage and metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer. In the neoadjuvant (before surgery) early-stage breast cancer setting, the Perjeta-based regimen has been shown to almost double the rate of pathological complete response compared to Herceptin and chemotherapy.5 Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) early-stage breast cancer setting.6 In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.7 Phesgo® – a subcutaneous fixed-dose combination of Perjeta and Herceptin – is also approved in more than 120 countries/regions and provides faster and more flexible administration of Perjeta and Herceptin under the skin in approximately eight minutes, compared to hours with standard IV administration.8,9 The European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended updating Phesgo's label in the European Union to allow administration outside of a clinical setting (such as in a person's home) by a healthcare professional, which can help to alleviate treatment burden and free up cancer care capacity in clinics.10 About Roche's medicines for human epidermal growth factor receptor 2 (HER2)-positive breast cancerRoche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early-stage and advanced HER2-positive disease. HER2-positive breast cancer affects approximately 15-20% of people with breast cancer.11 Survival outcomes for people with HER2-positive breast cancer, once seen as an aggressive type of the disease, have been transformed through the development of targeted therapies, including Roche molecules Herceptin® (trastuzumab), Perjeta® (pertuzumab), Kadcyla® (trastuzumab emtansine) and Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous).12,13 Long-term survival is now a possibility for many people, which also contributes to societal and economic benefits.14 Eligibility for treatment with Roche's HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease. About Roche in breast cancerOur medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by Loibl S, et al. Adjuvant pertuzumab or placebo + trastuzumab + chemotherapy (P or Pla + T + CT) in patients (pts) with early HER2-positive operable breast cancer in APHINITY: Final analysis at 11.3 years' median follow-up. Presented at: ESMO Breast Cancer; 2025 May 14-17; Munich, Germany. Abstract #LBA1.[2] Loibl S, et al. VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up. Annals of Oncology. 2022;33(9):986-987.[3] National Comprehensive Cancer Network (NCCN). NCNN Guidelines Insights [Internet; cited 2025 May]. Available from: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY) [Internet; cited May 2025]. Available from: Gianni L, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25-32.[6] Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377(2):122-131.[7] Swain M, et al. Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2015;372(8):724-734.[8] PHESGO pertuzumab/trastuzumab/hyaluronidase-zzxf. Recommended dosing and administration for PHESGO [Internet; cited 2025 May]. Available from: Perjeta pertuzumab. Early Breast Cancer Treatment. The infusion process [Internet; cited 2025 May]. Available from: O'Shaughnessy J, et al. Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. Eur J Cancer. 2021;152:223-232.[11] Ban M, et al. Early HER2-positive breast cancer: current treatment and novel approaches. Breast Care. 2020;15(6):560-569.[12] Ligorio F, et al. Prognostic impact of body mass index (BMI) in HER2+ breast cancer treated with anti-HER2 therapies: from preclinical rationale to clinical implications. Ther Adv Med Oncol. 2022;14(1):17588359221079123.[13] Mendes D, et al. The benefit of HER2-targeted therapies on overall survival of patients with metastatic HER2-positive breast cancer–a systematic review. Breast Cancer Research. 2015;17:140.[14] WifOR Institute. The Value of Investing in Innovative Medicines: Socioeconomic Burden and Annual Social Impact of Roche Treatments for HER2+ Breast Cancer, Multiple Sclerosis and Retinal Disease [Internet; cited 2025 May]. Available from: Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217 e-mail: Attachment 13052025_APHINITY Perjeta_enError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
13-05-2025
- Health
- Business Wire
Ten-Year APHINITY Data Show Genentech's Perjeta-based Regimen Reduced the Risk of Death by 17% in HER2-Positive Early-Stage Breast Cancer
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta ® (pertuzumab), Herceptin ® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo. 'Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen,' said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. 'These long-term data reinforce the regimen's value as a well-established standard-of-care treatment in the curative setting.' 'After ten years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival,' said Prof. Sibylle Loibl, APHINITY study chair, chair of the German Breast Group (GBG) and the chief executive officer of the GBG Forschungs GmbH. 'Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph node-positive disease who are at high risk of recurrence.' After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044). A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97). The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), strengthening results from earlier APHINITY analyses. No benefit was seen in the node negative subgroup. The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified. Full results will be presented as a late-breaking abstract on Thursday, May 15 at the 2025 European Society for Medical Oncology Breast Cancer Congress. 'The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings,' said Liz Frank, independent research advocate. 'Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring.' The collaborative efforts of Genentech, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer. About the APHINITY study APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877 / BO25126/ BIG 4-11) is a global, Phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta ® (pertuzumab) plus Herceptin ® (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer. The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment. Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life. What is Perjeta? Perjeta ® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and chemotherapy for: Use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer Use after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer that has a high likelihood of coming back Perjeta ® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer. Important Safety Information What are the possible side effects of Perjeta? Perjeta may cause serious side effects, including: Perjeta can cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure) Your doctor will run tests to monitor your heart function before and during treatment Based on these tests, your treatment may be interrupted or discontinued Contact a health care professional immediately if you experience any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects. Your doctor will verify your pregnancy status before treatment begins Birth control should be used while receiving Perjeta and for 7 months after your last dose of Perjeta. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping Perjeta If you think you may be pregnant, you should contact your healthcare provider immediately If you are exposed to Perjeta during pregnancy, or become pregnant while receiving Perjeta or within 7 months following the last dose of Perjeta with Herceptin, you are encouraged to report Perjeta exposure to Genentech at 1-888-835-2555 Who should not take Perjeta? Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta. What are other possible serious side effects of Perjeta? Serious side effects of Perjeta may also include: Infusion-related reactions: Perjeta is given as an infusion. Perjeta can cause serious infusion-related reactions, some fatal. When given alone, the most common infusion-related reactions were fever, chills, fatigue, headache, weakness, hypersensitivity, and vomiting. When given with Herceptin and docetaxel, the most common infusion-related reactions were fatigue, altered taste, hypersensitivity, muscle pain, and vomiting Severe allergic reactions: Perjeta can cause hypersensitivity reactions, including anaphylaxis and fatal events. Contact a health care professional immediately if you experience any of the following symptoms: swelling of the face, lips or tongue, trouble breathing, or chest pains The most common side effects of Perjeta include: The most common side effects of Perjeta when given with Herceptin and chemotherapy prior to surgery for early breast cancer include: Constipation Damage to the nerves (numbness, tingling, pain in hands/feet) Diarrhea Fatigue Hair loss Headache Decreased red blood cell counts, white blood cell counts, and platelet counts Mouth sores or blisters Nausea Muscle pain Vomiting Weakness The most common side effects of Perjeta when given with Herceptin and chemotherapy after surgery for early breast cancer include: Diarrhea Nausea Hair loss Fatigue Damage to the nerves (numbness, tingling, pain in hands/feet) Vomiting The most common side effects of Perjeta when given with Herceptin and docetaxel for metastatic breast cancer include: Diarrhea Hair loss Low levels of white blood cells with or without fever Nausea Fatigue Rash Damage to the nerves (numbness, tingling, pain in hands/feet) Side effects may vary based on chemotherapy regimen. These are not all the possible side effects of Perjeta. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Before you take Perjeta, tell your healthcare provider about all of your medical conditions, including if you: Have a history of heart disease Are pregnant or plan to become pregnant. Perjeta can harm your unborn baby Are breastfeeding or plan to breastfeed. It is not known if Perjeta passes into your breastmilk Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see the full Prescribing Information for additional Important Safety Information, including most serious side effects. What is Herceptin? Herceptin is approved for the treatment of early stage breast cancer that is H uman E pidermal growth factor R eceptor 2 -positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways: As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as ' AC→ TH.' With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as ' TCH.' Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy). Patients are selected for therapy based on an FDA-approved test for Herceptin. *High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3. Important Safety Information Possible serious side effects with Herceptin Not all people have serious side effects, but side effects with Herceptin therapy are common. Although some people may have a life-threatening side effect, most do not. A patient's doctor will stop treatment if any serious side effects occur. Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following: HEART PROBLEMS These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient's doctor will check for signs of heart problems before, during, and after treatment with Herceptin. INFUSION REACTIONS, including: Fever and chills Feeling sick to your stomach (nausea) Throwing up (vomiting) Pain (in some cases at tumor sites) Headache Dizziness Shortness of breath These signs usually happen within 24 hours after receiving Herceptin. A patient should be sure to contact their doctor if they: Are a woman who could become pregnant, or may be pregnant Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and for 7 months after your last dose of Herceptin. If you are or become pregnant while receiving Herceptin or within 7 months after your last dose of Herceptin, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555. Have any signs of SEVERE LUNG PROBLEMS, including: Severe shortness of breath Fluid in or around the lungs Weakening of the valve between the heart and the lungs Not enough oxygen in the body Swelling of the lungs Scarring of the lungs A patient's doctor may check for signs of severe lung problems when he or she examines the patient. Have LOW WHITE BLOOD CELL COUNTS Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone. A patient's doctor may check for signs of low white blood cell counts when he or she examines the patient. Side effects seen most often with Herceptin Some patients receiving Herceptin for breast cancer had the following side effects: Fever Feeling sick to your stomach (nausea) Throwing up (vomiting) Infusion reactions Diarrhea Infections Increased cough Headache Feeling tired Shortness of breath Rash Low white and red blood cell counts Muscle pain A patient should contact their doctor immediately if they have any of the side effects listed above. Patients are encouraged to report side effects to Genentech and the FDA. You may report side effects to FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Please see the full Prescribing Information, including Boxed WARNINGS and additional Important Safety Information, at About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit All trademarks used or mentioned in this release are protected by law.
Yahoo
13-05-2025
- Business
- Yahoo
Ten-Year APHINITY Data Show Genentech's Perjeta-based Regimen Reduced the Risk of Death by 17% in HER2-Positive Early-Stage Breast Cancer
– Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy – – 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease – – Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer Congress – SOUTH SAN FRANCISCO, Calif., May 13, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo. "Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen," said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "These long-term data reinforce the regimen's value as a well-established standard-of-care treatment in the curative setting." "After ten years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Prof. Sibylle Loibl, APHINITY study chair, chair of the German Breast Group (GBG) and the chief executive officer of the GBG Forschungs GmbH. "Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph node-positive disease who are at high risk of recurrence." After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044). A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97). The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), strengthening results from earlier APHINITY analyses. No benefit was seen in the node negative subgroup. The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified. Full results will be presented as a late-breaking abstract on Thursday, May 15 at the 2025 European Society for Medical Oncology Breast Cancer Congress. "The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings," said Liz Frank, independent research advocate. "Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring." The collaborative efforts of Genentech, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer. About the APHINITY study APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is a global, Phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer. The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment. Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life. What is Perjeta? Perjeta® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and chemotherapy for: Use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer Use after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer that has a high likelihood of coming back Perjeta® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer. Important Safety Information What are the possible side effects of Perjeta? Perjeta may cause serious side effects, including: Perjeta can cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure) Your doctor will run tests to monitor your heart function before and during treatment Based on these tests, your treatment may be interrupted or discontinued Contact a health care professional immediately if you experience any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects. Your doctor will verify your pregnancy status before treatment begins Birth control should be used while receiving Perjeta and for 7 months after your last dose of Perjeta. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping Perjeta If you think you may be pregnant, you should contact your healthcare provider immediately If you are exposed to Perjeta during pregnancy, or become pregnant while receiving Perjeta or within 7 months following the last dose of Perjeta with Herceptin, you are encouraged to report Perjeta exposure to Genentech at 1-888-835-2555 Who should not take Perjeta? Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta. What are other possible serious side effects of Perjeta? Serious side effects of Perjeta may also include: Infusion-related reactions: Perjeta is given as an infusion. Perjeta can cause serious infusion-related reactions, some fatal. When given alone, the most common infusion-related reactions were fever, chills, fatigue, headache, weakness, hypersensitivity, and vomiting. When given with Herceptin and docetaxel, the most common infusion-related reactions were fatigue, altered taste, hypersensitivity, muscle pain, and vomiting Severe allergic reactions: Perjeta can cause hypersensitivity reactions, including anaphylaxis and fatal events. Contact a health care professional immediately if you experience any of the following symptoms: swelling of the face, lips or tongue, trouble breathing, or chest pains The most common side effects of Perjeta include: The most common side effects of Perjeta when given with Herceptin and chemotherapy prior to surgery for early breast cancer include: Constipation Damage to the nerves (numbness, tingling, pain in hands/feet) Diarrhea Fatigue Hair loss Headache Decreased red blood cell counts, white blood cell counts, and platelet counts Mouth sores or blisters Nausea Muscle pain Vomiting Weakness The most common side effects of Perjeta when given with Herceptin and chemotherapy after surgery for early breast cancer include: Diarrhea Nausea Hair loss Fatigue Damage to the nerves (numbness, tingling, pain in hands/feet) Vomiting The most common side effects of Perjeta when given with Herceptin and docetaxel for metastatic breast cancer include: Diarrhea Hair loss Low levels of white blood cells with or without fever Nausea Fatigue Rash Damage to the nerves (numbness, tingling, pain in hands/feet) Side effects may vary based on chemotherapy regimen. These are not all the possible side effects of Perjeta. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Before you take Perjeta, tell your healthcare provider about all of your medical conditions, including if you: Have a history of heart disease Are pregnant or plan to become pregnant. Perjeta can harm your unborn baby Are breastfeeding or plan to breastfeed. It is not known if Perjeta passes into your breastmilk Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see the full Prescribing Information for additional Important Safety Information, including most serious side effects. What is Herceptin? Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways: As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→ TH." With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH." Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy). Patients are selected for therapy based on an FDA-approved test for Herceptin. *High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3. Important Safety Information Possible serious side effects with Herceptin Not all people have serious side effects, but side effects with Herceptin therapy are common. Although some people may have a life-threatening side effect, most do not. A patient's doctor will stop treatment if any serious side effects occur. Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following: HEART PROBLEMS These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient's doctor will check for signs of heart problems before, during, and after treatment with Herceptin. INFUSION REACTIONS, including: Fever and chills Feeling sick to your stomach (nausea) Throwing up (vomiting) Pain (in some cases at tumor sites) Headache Dizziness Shortness of breath These signs usually happen within 24 hours after receiving Herceptin. A patient should be sure to contact their doctor if they: Are a woman who could become pregnant, or may be pregnant Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and for 7 months after your last dose of Herceptin. If you are or become pregnant while receiving Herceptin or within 7 months after your last dose of Herceptin, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555. Have any signs of SEVERE LUNG PROBLEMS, including: Severe shortness of breath Fluid in or around the lungs Weakening of the valve between the heart and the lungs Not enough oxygen in the body Swelling of the lungs Scarring of the lungs A patient's doctor may check for signs of severe lung problems when he or she examines the patient. Have LOW WHITE BLOOD CELL COUNTS Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone. A patient's doctor may check for signs of low white blood cell counts when he or she examines the patient. Side effects seen most often with Herceptin Some patients receiving Herceptin for breast cancer had the following side effects: Fever Feeling sick to your stomach (nausea) Throwing up (vomiting) Infusion reactions Diarrhea Infections Increased cough Headache Feeling tired Shortness of breath Rash Low white and red blood cell counts Muscle pain A patient should contact their doctor immediately if they have any of the side effects listed above. Patients are encouraged to report side effects to Genentech and the FDA. You may report side effects to FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Please see the full Prescribing Information, including Boxed WARNINGS and additional Important Safety Information, at About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit All trademarks used or mentioned in this release are protected by law. View source version on Contacts Media Contact:Nicole Burkart, (650) 467-6800 Advocacy Contact:Julie Burns, (860) 881-6594 Investor Contacts:Loren Kalm, (650) 225-3217Bruno Eschli, +41616875284
