Latest news with #inavolisib
Telegraph
3 days ago
- Business
- Telegraph
Breakthrough breast cancer treatment could help 1,000 women a year
A new triple-drug treatment for aggressive advanced breast cancer can cut deaths by a third, a major trial has found. The international research used liquid biopsies – described as the 'golden key' to unlocking precision medicines – that identified suitable patients. All were suffering from one of the most common forms of breast cancer, which accounts for seven in 10 cases, and had a common mutation which makes it more deadly and aggressive. The three-drug therapy comprises two targeted drugs – palbociclib, a type of cancer growth blocker, and a new drug called inavolisib, which blocks the activity of the PI3K protein – as well as the hormone therapy fulvestrant. Until now, treatment options for such patients have been limited. The trial involving the Institute of Cancer Research and The Royal Marsden NHS Foundation Trust enrolled 325 patients from 28 countries, including the UK. In all cases, cancer had spread or returned after hormone therapy and for those who had not yet received systemic treatment for metastatic disease. Of the total, 161 were given the three-drug combination. The placebo group, which included 164 patients, was given a dummy pill plus palbociclib and fulvestrant. The study found the median overall survival in the inavolisib group was 34 months, compared with 27 months in the placebo group. The therapy was far more likely to result in significant shrinkage of tumours. In total, 62.7 per cent of patients in the inavolisib group saw their tumours shrink by more than 30 per cent, compared with 28 per cent in the placebo group. The randomised, double blind trial also showed that the new combination delayed the progression of the disease by 17.2 months, on average, compared with 7.3 months in the control group. Women taking inavolisib were able to delay subsequent chemotherapy treatment by almost two years longer than the patients in the control group. Around 55,000 women are diagnosed with breast cancer in the UK every year, and 11,500 will die from the disease. The study involved women with one of the most common types of disease, who had a mutation which is more aggressive and deadly. Experts said around 1,000 women a year could be helped by the drug combination. The study, funded by pharmaceutical company Roche, which manufactures inavolisib, was presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and simultaneously published in The New England Journal of Medicine. Lead author Nick Turner, professor of molecular oncology at the Institute of Cancer Research and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said the therapy 'not only helped patients live longer, but it more than doubled the time before their cancer progressed or worsened. 'It also gave them more time before needing subsequent chemotherapy, which we know is something that patients really fear and want to delay for as long as possible,' he said. The oncologist said he hoped the triple therapy would become the standard of care for women who can benefit. Previous trial results led the United States Food and Drug Administration (FDA) to grant 'breakthrough therapy' designation for inavolisib in May 2024 with costs of around $23,000 (£17,000) monthly. It has yet to be licensed in the UK. Professor Kristian Helin, chief executive of the Institute of Cancer Research, London, said: 'This research demonstrates how this triple combination approach, effectively shuts down cancer's escape routes, giving people with metastatic breast cancer the opportunity to live well for longer.' Dr Nisharnthi Duggan, research information manager at Cancer Research UK, said: 'These results are really positive news for people living with a type of hard-to-treat breast cancer. The trial showed that adding inavolisib to targeted treatment plans improved survival. On top of this, it also delayed the progression of people's cancer and the need for chemotherapy, which could improve quality of life. 'We hope that more research like this will help to give people kinder cancer treatment options, and more time with their loved ones.'
Sky News
3 days ago
- Business
- Sky News
New three-drug combination could help women with aggressive breast cancer live longer, study suggests
A new three-drug combination could help women with a common form of aggressive breast cancer live longer, a study has suggested. The trial, which included 325 patients from across 28 countries, showed the treatment more than doubled the time before the cancer "progressed or worsened", according to the lead author, and could delay the need for chemotherapy. The combination may become the "new go-to option" for women with PIK3CA-mutated hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer, said the researchers. This mutation in the PIK3CA gene causes cells to divide and replicate uncontrollably. More than half of the patients in the trial had metastatic breast cancer that had spread to three or more organs and the majority had already had chemotherapy. Researchers used a blood test known as a liquid biopsy, which detects tumour DNA in the blood, to test for the PIK3CA mutation. Of the total, 161 were given a three-drug combination comprising two targeted drugs - palbociclib, a type of cancer growth blocker, and a new drug called inavolisib, which blocks the activity of the PI3K protein - as well as the hormone therapy fulvestrant. The placebo group, which included 164 patients, was given a dummy pill plus palbociclib and fulvestrant. The median overall survival in the inavolisib group was 34 months, compared with 27 months in the placebo group. The three-drug therapy also delayed disease progression by 17.2 months, compared with 7.3 months in the placebo group, with patients also able to delay chemotherapy treatment by almost two years longer. The combined therapy of inavolisib, palbociclib and fulvestrant is not approved in the UK. However, the combination of palbociclib and fulvestrant has been available as an option for patients with certain types of breast cancer on the NHS since 2022. 1:48 'More time before needing chemotherapy' Lead author Nick Turner, a professor of molecular oncology, said: "The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. "It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible. The final results of the trial, by experts at the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust in London, have been published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. About 55,000 women are diagnosed with breast cancer in the UK every year, some 70% of whom will have HR+, HER2- breast cancer. PIK3CA mutations are found in 35-40% of HR+ breast cancers. Prof Kristian Helin, chief executive of the Institute of Cancer Research, London, said: "One of the challenges with combination therapies is ensuring the right drug dosages and understanding their individual effects. "It is extremely encouraging that this study not only demonstrates the effectiveness of this approach but also shows that the therapy was generally well tolerated by patients." Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, called the findings "a significant breakthrough".
Yahoo
3 days ago
- Business
- Yahoo
New Data Show Genentech's Itovebi Significantly Extended Survival in a Certain Type of HR-positive Advanced Breast Cancer
– The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone – – The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis – – New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine – SOUTH SAN FRANCISCO, Calif., May 31, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive final results from the overall survival (OS) analysis of the Phase III INAVO120 study. These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The results are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM). "For the first time, a PI3K pathway-targeted drug has shown it can help people with this breast cancer subtype live longer," said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "Itovebi exemplifies our continued commitment to improve survival rates for people with this common PIK3CA mutation, for whom more effective treatment options are needed." "The landmark data for the inavolisib-based regimen showed not only a doubling in progression-free survival, but importantly that it extended lives and gave people more time without chemotherapy," said Professor Nicholas Turner, lead study author and professor of molecular oncology at The Institute of Cancer Research, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, London, United Kingdom. "These results give us confidence that this regimen could become the new standard of care in the first-line setting, having demonstrated a substantial benefit on patient outcomes and quality of life." The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone. The median OS was 34.0 months (95% CI: 28.4–44.8) for people in the Itovebi arm, compared with 27.0 months (95% CI: 22.8–38.7) in the palbociclib and fulvestrant arm (stratified hazard ratio [HR]=0.67; 95% CI: 0.48–0.94, p-value=0.0190 [boundary=0.0469]). The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months (stratified HR=0.42, 95% CI: 0.32-0.55) in the comparator arm. The Itovebi-based regimen also led to a statistically significant improvement in objective response rate (the percentage of patients whose signs of cancer completely disappear or their tumors shrink significantly after treatment) and ad-hoc exploratory analyses showed it substantially delayed time to chemotherapy by approximately two years (stratified HR=0.43; 95% CI: 0.30-0.60). No new safety signals were observed at the time of the final OS analysis, with a low discontinuation due to adverse events supporting good tolerability. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored Phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations. We are exploring additional studies in breast cancer and other tumor types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. About the INAVO120 study The INAVO120 study [NCT04191499] is a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease. The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective response rate, and clinical benefit rate. Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations: in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862). in combination with dual HER2 blockade versus dual HER2 blockade and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239). in combination with CDK4/6i and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in endocrine-sensitive, PIK3CA-mutated HR-positive/HER2-negative breast cancer (INAVO123; NCT06790693). About hormone receptor (HR)-positive breast cancer HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases. A defining feature of HR-positive breast cancer is that its tumor cells have receptors that attach to one or both hormones – estrogen or progesterone – which can contribute to tumor growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options. The PI3K signaling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors. What is Itovebi? Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy. Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you. It is not known if Itovebi is safe and effective in children. Important Safety Information What are the possible side effects of Itovebi? Itovebi may cause serious side effects, including: High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including: difficulty breathing nausea and vomiting (lasting more than 2 hours) stomach pain excessive thirst dry mouth more frequent urination than usual or a higher amount of urine than normal blurred vision unusually increased appetite weight loss fruity-smelling breath flushed face and dry skin feeling unusually sleepy or tired confusion Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth: pain swelling redness ulcers Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea. Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects. The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include: decreased white blood cell counts, red blood cell counts, and platelet counts decreased blood levels of calcium, potassium, sodium, and magnesium increased creatinine blood levels tiredness increased blood levels of the liver enzyme alanine transaminase (ALT) nausea rash loss of appetite COVID-19 infection headache Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of Itovebi. 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 (877) 436-3683. Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you: have a history of diabetes or high blood sugar have kidney problems are pregnant or plan to become pregnant. Itovebi can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi. You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi. Males with female partners who are able to become pregnant: You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit 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) 467-6800Advocacy Contact:Julie Burns (860) 881-6594Investor Contacts:Loren Kalm (650) 225-3217Bruno Eschli +41 61 687 5284 Sign in to access your portfolio
Yahoo
3 days ago
- Business
- Yahoo
New data show Roche's Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer
The ItovebiTM (inavolisib)-based regimen reduced the risk of death by more than 30% in people with -mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone1 The mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis2,3 New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the 1 Basel, 31 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive final results from the overall survival (OS) analysis of the phase III INAVO120 study. These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer.1 The results are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).1 "For the first time, a PI3K pathway-targeted drug has shown it can help people with this breast cancer subtype live longer," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "Itovebi exemplifies our continued commitment to improve survival rates for people with this common PIK3CA mutation, for whom more effective treatment options are needed.' 'The landmark data for the inavolisib-based regimen showed not only a doubling in progression-free survival, but importantly that it extended lives and gave people more time without chemotherapy,' said Professor Nicholas Turner, Lead Study Author and Professor of Molecular Oncology at The Institute of Cancer Research, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, United Kingdom. 'These results give us confidence that this regimen could become the new standard of care in the first-line setting, having demonstrated a substantial benefit on patient outcomes and quality of life.' The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone.1 The median OS was 34.0 months (95% CI: 28.4–44.8) for people in the Itovebi arm, compared with 27.0 months (95% CI: 22.8–38.7) in the palbociclib and fulvestrant arm (stratified hazard ratio [HR]=0.67; 95% CI: 0.48–0.94, p-value=0.0190 [boundary=0.0469]).1 The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months (stratified HR=0.42; 95% CI: 0.32-0.55) in the comparator arm.1 The Itovebi-based regimen also led to a statistically significant improvement in objective response rate (the percentage of patients whose signs of cancer completely disappear or their tumours shrink significantly after treatment) and ad-hoc exploratory analyses showed it substantially delayed time to chemotherapy by approximately two years (stratified HR=0.43; 95% CI: 0.30-0.60).1 No new safety signals were observed at the time of the final OS analysis, with a low discontinuation due to adverse events supporting good tolerability.1 The Itovebi-based regimen is approved in the United States, Switzerland, Canada, Australia, United Arab Emirates and China. In May, it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), with a final decision regarding the approval expected from the European Commission in the near future. Data from the INAVO120 study are currently under review with other global health authorities. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations.4-7 We are exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. About Itovebi TM (inavolisib)Itovebi is an oral, targeted treatment that has been shown to provide well-tolerated and durable disease control in people with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.2,3,8 Itovebi has been designed to help minimise the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.9,10 About the INAVO120 studyThe INAVO120 study [NCT04191499] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.4 The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.4 The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause.4 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.4 Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:5-7 in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862). in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trastuzumab for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239). in combination with CDK4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in the first-line setting in PIK3CA-mutated HR-positive/HER2-negative, endocrine-sensitive breast cancer (INAVO123; NCT06790693). About hormone receptor (HR)-positive breast cancerHR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.11,12 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to one or both hormones – oestrogen or progesterone – which can contribute to tumour growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.12-14 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.3 About Roche in breast cancerRoche 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 oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.11,12About 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 Turner NC, et al. INAVO120 Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2025 May 30-June 03; Chicago, USA. Abstract #1003.[2] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22(1):1002.[3] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.[4] A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 May]. Available from: [5] A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 May]. Available from: [6] A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 May]. Available from: [7] A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 May]. Available from: Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96.[9] Juric D, et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05.[10] Hong R, et al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates robust efficacy in PIK3CA mutant breast cancer models as a single agent and in combination with standard of care therapies. Cancer Res. 2018;78(4):4-14.[11] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 May]. Available from: [12] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.[13] Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20.[14] Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1):10. 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 3217e-mail: Attachment 31052025_INAVO120 study Itovebi_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
Medscape
23-05-2025
- Health
- Medscape
Benefits Persist With Inavolisib in Breast Cancer
New findings from the phase 3 INAVO120 trial underscore the durable benefits of inavolisib added to standard therapy for PIK3CA -mutated hormone receptor–positive (HR+) human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer. The drug, in combination with palbociclib and fulvestrant, was approved in October 2024 by the US Food and Drug Administration based on previously published progression-free survival benefits. Now, mature overall survival (OS) results and longer follow-up strengthen evidence for the triplet combination, said lead author and oncologist, Nicholas C. Turner, MD, PhD, during a press conference for the American Society of Clinical Oncology (ASCO) 2025 annual meeting. 'Importantly, this is the first time that OS has been improved by a PI3 kinase pathway targeted drug…we delayed the time to chemotherapy by almost 2 years, and the adverse event profile was consistent with previous reports, with low inavolisib discontinuation rates due to adverse events,' said Turner. The INAVO120 trial included 325 patients with HR+ HER2− advanced breast cancer and a PIK3CA -mutation who had either failed hormone therapy or progressed within 1 year. Patients were randomized to either standard therapy consisting of palbociclib and fulvestrant (placebo, n = 164) or the triplet combination that included standard therapy plus inavolisib (n = 161). With a median follow-up now up 34.2 months, the study showed a 33% reduction in the risk of death in the inavolisib arm, translating to an OS of 34 months compared with 27 months in the placebo group (stratified hazard ratio [sHR] 0.67; P = .0190), he reported, in the press conference. 'We also looked at an endpoint that is really important for patients, which is the time until they have to consider chemotherapy-based care, and this was substantially improved…with almost a 2-year delay on average, to the time of needing to have chemotherapy,' he said. Specifically, while patients in the placebo group needed chemotherapy at a median of 12.6 months, this was delayed until 35.6 months in the inavolisib group (sHR, 0.43). Additionally, the previously published primary endpoint of median progression-free survival, which strongly favored inavolisib after a follow-up of roughly 21 months, (15.0 vs 7.3 months, sHR 0.43; P < .001) was maintained with longer follow-up (17.2 vs 7.3 months; sHR, 0.42). With the extended time on therapy, adverse events remained 'generally manageable,' said Turner, although he cautioned 'this is not a drug without side effects.' In total, 90.7% of patients in the inavolisib arm, and 84.7% in the placebo arm had grade 3/4 adverse events. Hyperglycemia (any grade) was experienced by 63.4% of the inavolisib group and 13.5% of the placebo group, and adverse events leading to discontinuation occurred in 6.8% and 0.6% or trial participants in each of the groups, respectively. Previously, attempts to combine PI3K inhibitors with CDK4/6 inhibitors were not possible because side-effects were much worse, explained Turner. But the specificity of inavolisib has decreased that risk. 'So, that maximizes your ability to hit PI3 kinase in the tumor while relatively sparing normal cells in the body and reducing side effects,' Turner said, during the press conference. Commenting on the study, ASCO chief medical officer and spokesperson Judy Gralow, MD, said she was particularly impressed with the therapy's benefit on time to next chemotherapy. 'Delaying the need, in the metastatic setting, to go on chemotherapy by almost 2 years is certainly an outcome that matters to patients,' she said. 'It is clear that, at least in a majority of breast cancers at the time of recurrence, we should be testing for PIK3CA mutations, as well as other alterations that direct therapy.' However, she cautioned that the triplet therapy is only indicated in a subset of PIK3CA -mutated HR+ HER2− advanced breast cancer: namely those who have progressed either during, or within a year of hormone therapy. 'So, this is not all comers, [such as] patients who had tumors that 5 years later, 7 years later, showed evidence of recurrence.' Calling the study results 'a big step forward' for this patient group, Jane Lowe Meisel, MD, co-director, Breast Medical Oncology, at the Winship Cancer Institute of Emory University School of Medicine, Atlanta, said the study 'illustrates the importance of genomic testing at the time of diagnosis of hormone receptor–positive metastatic breast cancer, so that patients with PIK3CA mutations who qualify for this approach can be readily identified.' Turner disclosed consulting or advisory roles with AstraZeneca, Exact Sciences, Gilead Sciences, GlaxoSmithKline, Guardant Health, Inivata, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Relay Therapeutics, Repare Therapeutics, and Roche. He also received research funding with AstraZeneca; Guardant Health; Inivata; Invitae; Merck Sharpe & Dohme; Natera; Personalis; Pfizer; and Roche. Meisel disclosed consulting or advisory roles with AstraZeneca, GE Healthcare, Genentech, Novartis, Olema Oncology, Pfizer, Seagen, Sermonix Pharmaceuticals, and Stemline. She also disclosed research funding from AstraZeneca, Olema Oncology, Pfizer, Seagen, and Sermonix Pharmaceuticals. Gralow disclosed having no conflicts of interest. The study was funded by F. Hoffmann–La Roche and a grant (P30CA008748) to the Memorial Sloan Kettering Cancer Center.
