Latest news with #JohnHeymach
Yahoo
08-08-2025
- Health
- Yahoo
U.S. FDA grants accelerated approval to Boehringer's HERNEXEOS® as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC
Illustrative image This press release is not intended for UK media. HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 75% (N=71), as demonstrated in the Beamion-LUNG 1 clinical trial1 Accelerated approval follows Priority Review and Breakthrough Therapy Designation granted by the U.S. FDA for the treatment of patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer Ridgefield, Conn. U.S. and Ingelheim, Germany - Boehringer Ingelheim's HERNEXEOS® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.1 This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 'With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant non-small cell lung cancer in the U.S. that not only elicits a durable response but, importantly, has a manageable safety profile,' said Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, and coordinating investigator for the Beamion-LUNG 1 trial. 'In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care.' Accelerated approval is based on data from the Phase Ib Beamion-LUNG 1 trial, demonstrating an objective response rate of 75% (N=71), 6% of patients had a complete response and 69% of patients had a partial response and a duration of response of ≥6 months in 58% of patients (n=53).1 Positive results from the Beamion-LUNG 1 trial were previously presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine.2 Zongertinib demonstrated a manageable safety profile with a 2.9% discontinuation rate. In the pooled safety population, the most common (> 20%) adverse reactions were diarrhea (53%), hepatotoxicity (27%), rash (27%), fatigue (22%), and nausea (21%).1 'We are grateful to be able to bring forward HERNEXEOS, which has the potential to reset the benchmark for those living with HER2-mutant advanced non-small cell lung cancer, a condition associated with a particularly poor prognosis,' said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. 'Believing in the power of scientific innovation, we aim to provide meaningful improvements to this patient population. Recognizing its potential, we accelerated development to deliver this new treatment option to patients within four years of starting the first clinical trial." Harnessing the power of precision medicine by targeting HER2 mutations in lung cancer HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.3,4,5 Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.3,5 Comprehensive biomarker testing using next generation sequencing determines a patient's eligibility for treatment with zongertinib by identifying HER2 (ERBB2)-mutant advanced NSCLC.1,5 'The advocacy community is thrilled about the approval of zongertinib, as it is another testament to the importance of personalized options for lung cancer that allow for a much more targeted approach for a subgroup of patients who have been waiting many years for innovative treatments,' said Marcia Horn, President and CEO, International Cancer Advocacy Network and Executive Director of the Exon 20 Group/HER2 Warriors. 'Understanding your cancer's unique biomarkers, including HER2, through comprehensive testing is critical for all patients with NSCLC, as it can unlock targeted treatment options.' About non-small cell lung cancer (NSCLC) Lung cancer claims more lives than any other cancer type and the incidence is set to increase to over 3 million cases worldwide by 2040.5,6 NSCLC is the most common type of lung cancer.3 Due to a lack of symptoms and misdiagnoses,7 most patients with NSCLC present at stage III or IV, where the disease has metastasized locally or to other organs.8 The estimated 5-year survival rate historically has been less than 10% for metastatic disease.9,10,11 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.12,13,14 About zongertinib Zongertinib is a tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2).1 This orally administered, targeted therapy was approved as HERNEXEOS® (zongertinib tablets) under the FDA's Accelerated Approval Program, after securing Priority Review as well as Breakthrough Therapy and Fast Track Designations.1 The treatment is being evaluated in ongoing trials, across a range of advanced solid tumors with HER2 alterations. About Boehringer Ingelheim in oncology We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim's generational commitment to driving scientific innovation is reflected by the company's robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer's ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. Read more at and, About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at and The following information is intended for U.S. audiences only: About HERNEXEOS® HERNEXEOS® (zongertinib tablets) is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. Boehringer Ingelheim's CareConnect4Me patient support program Boehringer's goal is to make HERNEXEOS® (zongertinib tablets) easily accessible in the U.S. through a comprehensive patient support program, CareConnect4MeTM, that provides a broad range of access and clinical support solutions, including financial support services. For those in the U.S., visit or call 1-855-297-5903 to learn more. What is HERNEXEOS (zongertinib tablets)? HERNEXEOS is a prescription medicine used to treat adults with a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that: cannot be removed by surgery or that has spread to other parts of your body (metastatic), an has a certain mutation in the human epidermal growth factor receptor 2 (HER2) gene, and who have previously received treatment by mouth or injection (systemic therapy). Your healthcare provider will perform a test to make sure HERNEXEOS is right for you. It is not known if HERNEXEOS is safe and effective in children. IMPORTANT SAFETY INFORMATION Before taking HERNEXEOS, tell your healthcare provider about all of your medical conditions, including if you: have liver problems. have heart problems. have lung or breathing problems other than lung cancer. are pregnant or plan to become pregnant. HERNEXEOS can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with HERNEXEOS. Use an effective form of birth control (contraception) during treatment with HERNEXEOS and for 2 weeks after your last dose. Talk to your healthcare provider about birth control methods that might be right for you during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with HERNEXEOS. are breastfeeding or plan to breastfeed. It is not known if HERNEXEOS passes into your breastmilk. Do not breastfeed during treatment and for 2 weeks after your last dose of HERNEXEOS. Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. HERNEXEOS may affect the way other medicines work, and other medicines may affect how HERNEXEOS works. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. What are the possible side effects of HERNEXEOS? HERNEXEOS may cause serious side effects, including: liver problems. Liver problems are common with HERNEXEOS and can be severe and life threatening. Your healthcare provider will do blood tests to check your liver function before you start taking HERNEXEOS and during your treatment. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including: yellowing of your skin or the white part of your eyes (jaundice) dark or brown (tea colored) urine pain on the upper right side of your stomach area (abdomen) bleeding or bruising more easily than normal feeling very tired loss of appetite nausea or vomiting heart problems that may affect your heart's ability to pump blood. HERNEXEOS can cause heart problems. Your healthcare provider will do tests to check your heart function before you start taking HERNEXEOS and during treatment. Tell your healthcare provider right away if you have any new or worsening symptoms of heart problems, including: feeling like your heart is pounding or racing Dizziness Tiredness feeling lightheaded shortness of breath loss of consciousness coughing swelling of your legs, ankles, or feet lung problems. HERNEXEOS can cause lung problems that are severe or life-threatening. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever. Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with HERNEXEOS if you have serious side effects. The most common side effects of HERNEXEOS include: diarrhea. HERNEXEOS can cause severe diarrhea. Tell your healthcare provider right away if you have diarrhea. liver problems Rash feeling tired nausea The most common severe abnormal blood tests include decreased white blood cell count, increased liver function tests, and decreased potassium levels. HERNEXEOS may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of HERNEXEOS. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. For U.S. Healthcare Professionals, please see full Prescribing Information. CL--100065 07.28.2025 References: 1HERNEXEOS Prescribing Information 2Heymach, J. et al. Zongertinib in previously treated HER2-mutant non-small cell lung cancer. N Engl J Med. 2025;01-13. 3Baraibar I, et al. Novel drugs targeting EGFR and HER2 exon 20 mutations in metastatic NSCLC. Crit Rev Oncol Hematol. 2020;148:102906. 4Li, B.T. et al. Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer. N Engl J Med. 2022;386:241–51 5Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021 May 3;1(2):58-73. 6International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: (Accessed: January 2025). 7American Cancer Society. Lung Cancer Early Detection, Diagnosis, and Staging. Available at: (Accessed: January 2025). 8Casal-Mouriño, A. et al. Epidemiology of stage III lung cancer: frequency, diagnostic characteristics, and survival. Transl Lung Cancer Res. 2021;10(1):506-518. 9National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). 5-Year Survival (Accessed July 2025). 10Belaroussi, Y. et al. Survival outcomes of patients with metastatic non-small cell lung cancer receiving chemotherapy or immunotherapy as first-line in a real-life setting. Sci Rep. 2023.13, 9584. 11Simeone, J. C. et al. Treatment patterns and overall survival in metastatic non-small-cell lung cancer in a real-world US setting. Fut. Oncol. Lond. Engl. 2019. 15(30), 3491–3502. 12Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022 Jun; 41(6): 379–388. 13Andersen, B. L. et al. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020 Jul;145:195-204. 14Presley, C. J. et al. Functional Disability Among Older Versus Younger Adults With Advanced Non–Small-Cell Lung Cancer. JCO Oncol Pract. 2021 May 3;17(6):e848–e858. Attachment Illustrative imageError 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
CNBC
17-06-2025
- Business
- CNBC
Targeted cancer drugs may replace chemo for some patients — and drugmakers say they're getting closer
Chemotherapy has long been a cornerstone of cancer treatment, saving millions of lives. But the pharmaceutical industry says a popular class of targeted cancer therapies could one day replace chemotherapy and its potential for harsh side effects. Antibody-drug conjugates (ADCs) have taken major strides in recent years, as companies including AstraZeneca, Daiichi Sankyo, Pfizer and Merck are developing drugs in the space that could ease the trials of cancer treatment and make them big money in the process. Drugmakers have poured billions of dollars into developing ADCs. The medicines are designed to deliver potent chemotherapy directly to cancer cells while sparing surrounding healthy cells. That's unlike traditional chemotherapy, which can affect both types of cells. But it will likely take years before ADCs can replace chemo, and some outside cancer experts say the pharmaceutical industry still has more work to do to refine the treatments. "I think we've had some successes in the space, but I think the early hopes that they would sweep away the need for chemotherapy have mostly been unfulfilled so far," Dr. John Heymach, chair of thoracic/head and neck medical oncology at MD Anderson Cancer Center, told CNBC. "There's clearly room for improvement." Still, some companies say ADCs have shown the ability to replace chemotherapy in certain settings. Other drugmakers say they are inching closer to developing ADCs that can be used before chemo — or at the very least, learning from previous missteps. "We are leading the way towards establishing ADCs as a precision-based approach to replace classic chemotherapy," David Fredrickson, executive vice president of AstraZeneca's oncology business, told CNBC. He was in part referring to AstraZeneca's promising data shared at the 2025 American Society of Clinical Oncology annual meeting in Chicago, where several other companies also delivered positive results on existing and experimental ADCs – or even data that could lead to new standards in cancer care. Since the first ADC hit the market in 2000, the field has made major progress. More than a dozen ADCs are now approved in the U.S., and some have become a preferred or commonly used treatment option for specific tumors. Hundreds more ADCs are in development. Large pharmaceutical companies have scooped up many of the approved and experimental ADCs in massive deals, such as Pfizer's $43 billion acquisition of Seagen in 2023. A range of drugmakers want in on the hype, and for good reason. ADCs could account for $31 billion of the $375 billion worldwide cancer market in 2028, according to estimates from the drug market research firm Evaluate. ADCs still pose major challenges. Among them, some treatments can release the toxic chemotherapy "payload" into the bloodstream too soon, affecting healthy cells and causing a range of side effects. Some health experts say drugmakers also need to identify the right cancer-causing proteins to target and new payloads for these drugs. The pharmaceutical industry is working to overcome these issues by developing next-generation ADCs and combination regimens. Some ADCs, such as a newly approved therapy from AbbVie, target new proteins, while others use new so-called linker platforms that better control when and where the toxic payload is released. "It's been hard. We haven't optimized everything perfectly yet. But I think that the field is still growing fast, and it's making improvements every year," said Dr. Jeffrey Infante, global head of early clinical development, translational research and oncology at Johnson & Johnson, which has several experimental ADCs. Most ADCs consist of three components: an antibody that targets a protein found in high amounts on the surface of cancer cells, a chemotherapy payload and a linker that connects them. The antibody guides the ADC to the cancer cell, and once inside, the linker releases the chemotherapy to kill the cancer from within. Newer ADCs leading the space, such as Enhertu from AstraZeneca and Daiichi Sankyo, improve on that design and are moving closer to becoming standard treatments for certain cancers. Enhertu delivers more chemotherapy per dose than older ADCs and uses a smart linker designed to release the drug only inside tumors. It can also kill nearby cancer cells with lower levels of HER-2, the protein it targets – a major milestone in oncology. Enhertu is approved in the U.S. to treat certain breast, lung and gastric cancers, with 2024 sales from both companies topping $3.7 billion. New data presented at ASCO could expand Enhertu's use and shift how breast cancer is treated for the first time in a decade. Enhertu stalled the growth of a common type of breast cancer by over a year in a late-stage trial when used as an initial treatment, and compared to a standard regimen containing chemotherapy. The study combined Enhertu with a medicine called pertuzumab as a first option for patients with HER-2-positive metastatic breast cancer. AstraZeneca and Daiichi Sankyo are seeking approval for that use. "We're moving this drug earlier and earlier, and the magnitude of benefit gets bigger and bigger," said Ken Keller, Daiichi Sankyo's CEO and head of oncology business. "The hope is that we can move it into earlier-stage settings where curing is the goal." Keller said the results and previous Enhertu data show "you can replace and knock the chemotherapy out." The companies also plan to release data on a subset of patients in the study who took Enhertu alone. MD Anderson's Heymach said the data "is the type of clear, major advance that we'd like to see more often, where this ADC could become the first option for patients." Other ADCs are advancing, too. Pfizer's Adcetris, which it acquired from Seagen, is approved as an initial treatment with chemotherapy for certain lymphomas. It raked in almost $1.1 billion in sales in 2024. Padcev from Pfizer and Astellas Pharma is approved with Merck's Keytruda as a first-line bladder cancer therapy, and booked $1.69 billion in sales last year. Keytruda is a blockbuster immune checkpoint inhibitor that blocks a protein called PD-1, helping immune cells more effectively recognize and kill cancer cells. Gilead's Trodelvy, an ADC that took in $1.3 billion in revenue in 2024, also turned heads at ASCO. As a first-line treatment, Trodelvy combined with Keytruda lowered the risk of disease progression by 35% in patients with an aggressive type of breast cancer in a late-stage trial. The study examined patients with advanced triple-negative breast cancer whose tumors express PD-L1. "What these studies demonstrate is that if you replace the chemotherapy with the antibody drug conjugate, then you do get improved efficacy and improved safety," said Dr. Dietmar Berger, Gilead's chief medical officer. Berger said there are early signs that the combination may also help patients live longer, but the data is still new. Gilead is also studying Trodelvy as a first-line treatment in another type of breast cancer and non-small cell lung cancer. The ASCO data was a win for Gilead after recent setbacks for Trodelvy. In October, Gilead pulled Trodelvy from the bladder cancer market in the U.S. after disappointing results in a trial meant to confirm its benefit. In January 2024, Trodelvy failed a phase three trial in non-small cell lung cancer. Berger said that's one challenge of developing ADCs: effectiveness can vary by cancer type, so some patients may benefit from a drug more than others. "You need to learn from the different studies and see the exact populations that might benefit," Berger said, adding that developing across cancers isn't "linear." British drugmaker GSK is learning from its missteps, too. The company pulled its blood cancer ADC, Blenrep, from markets worldwide in 2022 after it failed a study meant to verify its benefit. But Blenrep is now reapproved in the U.K., with a U.S. decision due on July 23. GSK's Chief Commercial Officer Luke Miels said the company had to "go back to the drawing board" to revive Blenrep, which involved building a team with deeper ADC expertise and reevaluating dosing. Blenrep, when combined with other therapies, has since succeeded in two key studies in previously treated blood cancer patients. Under its original approval, it was used on its own. GSK also presented data at ASCO showing Blenrep's main side effect – blurred vision in about 1 in 3 patients – is reversible and manageable with lower or spaced-out dosing. The company expects up to £3 billion ($3.97 billion) in peak annual Blenrep sales. It is also studying the drug as a first-line treatment, which could add to that revenue forecast, Miels said. Meanwhile, Merck and Daiichi Sankyo face a new hurdle for a drug they are developing. In May, they withdrew their U.S. application for an ADC targeting HER-3 after it failed to extend overall survival in a late-stage lung cancer trial. They scrapped the application even though the ADC met the study's main goal last year: delaying tumor progression compared to chemotherapy in patients previously treated for a certain non-small cell lung cancer. The drug is one of three ADCs that Merck is co-developing with Daiichi Sankyo as it prepares for Keytruda's upcoming patent expiration. Marjorie Green, Merck's head of oncology global clinical development, said the companies are learning from "what worked and what didn't" and still fully investing in refining the drug, with plans to test it in late-stage breast cancer trials. Other companies are trying to make waves in the ADC space with new approaches to the drugs. AbbVie, for example, is successfully developing ADCs with new cancer-causing protein targets. The company in May scored U.S. approval for the first-ever ADC targeting a protein called c-Met, which can be found in high levels in non-small cell lung cancer and is associated with a low likelihood of recovery or improvement. But the company also released several trial results on a next-generation product that could become a best-in-class c-Met ADC, said Pedro Valencia, the company's vice president of solid tumor pipeline strategy and execution. He called it the result of years of fine-tuning the company's ADC platform to "get to that sweet spot." AbbVie also released data on its ADC targeting SEZ6, a unique protein that is overexpressed in neuroendocrine tumors such as small-cell lung cancer but not in normal tissue, Valencia said. That ADC has demonstrated response rates that are two to three times more than chemotherapy in those tumors, he said. Meanwhile, Bristol Myers Squibb is developing a bispecific ADC, said the company's Chief Medical Officer Samit Hirawat. Those are designed to target two different proteins, or parts of a protein, on cancer cells to make the drug more precise and effective. Through a partnership with Chinese company SystImmune, Bristol Myers Squibb is developing a drug that hits EGFR and HER-3, both common in multiple cancers. Hirawat said the drug carries more chemotherapy per dose than older ADCs and uses a linker that appears to help avoid a common side effect of rival treatments called interstitial lung disease, a group of conditions that cause lung scarring. A phase three trial is underway in triple-negative breast cancer, with more late-stage studies planned. Hirawat said the company is also exploring non-chemotherapy payloads to improve efficacy and safety. That includes protein degraders, which eliminate cancer-causing proteins instead of blocking them. Eli Lilly is also developing ADCs with non-chemotherapy payloads, said Jake Van Naarden, president of Lilly Oncology. He said new types of payloads could help patients who relapse on existing ADCs, shrinking their "newly growing cancers" again in "a durable way." Dr. Jennifer Suga, co-chair of Kaiser Permanente's National Lung Cancer Program, said developing alternative payloads will be crucial, as cancer cells may become "resistant" to those used in current ADCs. Eli Lilly is also using linker technology from Mablink, acquired in 2023, to help its ADCs stay in the body longer and reach tumors more effectively. At ASCO, Eli Lilly released the first human data on an ADC that uses that linker and targets folate receptor alpha, a protein commonly found in ovarian cancer. AbbVie's approved ADC, Elahere, already targets that protein. But Eli Lilly hopes its drug can have fewer side effects, Van Naarden said. In the early trial, the company did not observe any eye-related effects linked to other ADCs. J&J hopes to stand out by focusing on prostate cancer, where it has deep expertise. The lead ADC J&J acquired from the Ambrx targets PSMA, a protein common in prostate tumors. There are currently no approved ADCs with that target. Infante said that ADC has a "very stable" linker platform and can be paired with an existing diagnostic test, allowing the company to easily identify eligible patients for the drug. Chemotherapy likely won't disappear entirely and could still offer "major benefits" as a later treatment option in some cases, according to MD Anderson's Heymach. But he and drugmakers expect more ADCs will be used to treat solid tumors – cancers that form as masses in organs like the lungs, breasts or ovaries – before chemotherapy over the next decade. Heymach said "more effective combinations" of ADCs and other drugs could help establish more ADCs as go-to treatment options across a wider range of cancers. Pfizer believes immune checkpoint inhibitors such as Keytruda are a particularly promising match for its ADCs, said the company's Chief Scientific Officer Chris Boshoff. Pfizer's ADCs, built on its vedotin platform, do more than just kill tumor cells. Boshoff said they also trigger immunogenic cell death – a process that sends distress signals to alert the immune system and train it to recognize and attack similar cancer cells. That sets the stage for checkpoint inhibitors to do their job even more effectively, which is to release the "brakes" on the body's immune system and help it mount a stronger attack on cancer. Together, they create a one-two punch: ADCs kill the cancer and sound the alarm, while checkpoint inhibitors enable the immune system to fully attack. "When we combine them, we see increased response rates, increased progression-free survival, and in the cases where we have tested, an increase in overall survival," Boshoff said, referring to measures of cancer treatment effectiveness. At ASCO, Pfizer shared early but encouraging data on two vedotin-based ADCs in combination with Keytruda. That includes one targeting a protein commonly found in lung cancers called integrin B6, and another targeting PD-L1. Boshoff said the results support starting late-stage trials this year on those combinations in certain cancers. Pfizer is also betting on a combination ADC approach with a drug it gained the rights for through a licensing agreement with Chinese company 3SBio: a bispecific antibody drug targeting PD-L1 and VEGF. BioNTech is banking on a similar combination approach with its bispecific antibody drug that targets those same two proteins. Bristol Myers Squibb in June said it will pay $1.5 billion in upfront fees to co-develop that product. BioNTech in April released the first early data to back that combination approach, but will also have to prove each of its four ADCs as solo treatments in trials, said Chief Commercial Officer Annemarie Hanekamp. She said BioNTech believes ADCs could take the place of traditional chemotherapy. But the company also hopes its bispecific antibody drug could serve as an improved version of immunotherapies that only target PD-1, such as Keytruda and Bristol Myers Squibb's Opdivo. "We can then combine these two powers together and that's truly exciting," Hanekamp said, noting that BioNTech has multiple trials on the combination approach ongoing. At J&J, Infante said the company plans to be the first to test an ADC in combination with one of its T-cell engagers – a type of immunotherapy that directs immune cells to recognize and kill cancer cells. The company is preparing to start enrolling patients in trials on that combination regimen, he said.
Yahoo
09-06-2025
- Business
- Yahoo
OPKO Health's ModeX Therapeutics Announces Formation of Scientific Advisory Board with Leaders at the Forefront of Immunology and Oncology Drug Development
Will provide expertise across ModeX's portfolio of next generation multispecific antibodies for complex diseases involving the immune system, including cancer ModeX's promising immunology pipeline includes first-in class drugs with two assets in ongoing clinical trials and multiple pre-IND assets to enter clinical trials WESTON, Mass., June 09, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced the creation of a Scientific Advisory Board to provide counsel and insight into the development of ModeX's immunology and oncology-focused pipeline featuring potential first-in-class multispecific antibodies and vaccines developed with its proprietary MSTAR platform technology. Aligned with the company's primary areas of focus, the board is comprised of established leaders across complex diseases involving the immune system including cancer, immune-mediated disease, and infectious diseases. The founding members include Drs. John Heymach, Ronald Levy, Myron Cohen, and Rafi Ahmed. Each of these globally recognized researchers brings notable contributions to biomedical research and the translation of therapeutics to impact public health. 'We are excited to welcome to our team four eminent scientists who share our vision of advancing next-generation immune therapies that simultaneously attack multiple targets and help patients overcome devastating diseases,' said Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX, and Chief Innovation Officer of OPKO. Members of the ModeX Scientific Advisory Board include the following: Rafi Ahmed, Ph.D. - Director of the Emory Vaccine Center and Georgia Research Alliance Eminent Scholar, Emory University School of Medicine. Dr. Ahmed's work in immunology has been highly influential in shaping our understanding of immunological memory to vaccines and T cell exhaustion during chronic viral infection. These findings have led to improved vaccination strategies and to the development of PD-1 directed immunotherapy for cancer. Dr. Ahmed is a member of the National Academy of Sciences, the National Academy of Medicine, and the American Academy of Arts and Sciences. Myron Cohen, M.D. - Professor of Medicine, Microbiology, and Immunology at the University of North Carolina (UNC), Director at the UNC Institute for Global Health and Infectious Diseases, Associate Vice Chancellor for Global Health at UNC, and Associate Director of the UNC Center for AIDS Research. Dr. Cohen's career has focused on the transmission of STDs, including HIV, and strategies for prevention. He was an architect of landmark studies that demonstrated that treatment of HIV prevents its transmission, a catalyst for current global HIV prevention efforts. John Heymach, M.D., Ph.D. - Chair of Thoracic/Head and Neck Medical Oncology and a professor at the University of Texas MD Anderson Cancer Center. He is a co-leader of the Center's Lung Cancer Moon Shot and serves as a Principal Investigator of lung cancer programs funded by the National Cancer Institute, LUNGevity, and the American Association for Cancer Research. His research has led to novel therapeutic approaches for multiple types of lung cancer, and as a clinical investigator, he leads several biomarker-directed clinical trials using targeted and immunotherapy agents. Ronald Levy, M.D. - Professor of Medicine and Co-Director of the Hematologic Malignancies Program at Stanford University. He also serves as Associate Director of Translational Science for the Stanford Cancer Institute. His research has focused on monoclonal antibodies and the study of malignant lymphoma. Dr. Levy was a pioneer in successfully treating cancer with monoclonal antibodies and played a role in the development of rituximab for the treatment of lymphomas. 'Through my research I have witnessed how targeted antibody therapies have transformed the treatment of cancer and profoundly impacted patients' lives globally,' said Dr. Ronald Levy, a Professor of Medicine, and Co-Director of the Hematologic Malignancies Program at Stanford University. 'Multispecific treatments are writing the next chapter by overcoming the limitations of existing antibody treatments and expanding accessibility to many more patients. Alongside the experts joining me on this advisory board, I look forward to helping the ModeX team fulfill this mission.' 'Drs. Heymach, Levy, Cohen, and Ahmed are globally recognized leaders in their respective field. We are grateful for their interest, counsel and support to achieve the full potential of our proprietary multispecific antibody technologies including to revolutionize the treatment landscape for millions of patients,' said Phillip Frost, M.D., Chairman and Chief Executive Officer, and Elias Zerhouni, M.D., Vice Chairman and President, of OPKO. Beyond bispecifics: ModeX's multispecific antibody platformMultispecific therapeutics represent the future of medicine. Many untreatable or complex conditions arise from multiple disease pathways, yet most medicines only act on a single target. ModeX overcomes these challenges by combining natural protein structures to create unique multispecific medicines that can harness the immune system and address the complexity of disease. About ModeX TherapeuticsModeX Therapeutics is the leading clinical-stage biopharmaceutical company developing unique and proprietary multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency to fight complex diseases. Its promising first-in-class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, as well as several of the world's most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is an OPKO Health company based in Weston, Massachusetts. For more information, please visit About OPKO Health, is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and novel and proprietary technologies. For more information, visit Cautionary Statement Regarding Forward-Looking StatementsThis press release contains 'forward-looking statements,' as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as 'expects,' 'plans,' 'projects,' 'will,' 'could,' 'may,' 'anticipates,' 'believes,' 'should,' 'intends,' 'estimates,' and other words of similar meaning, including whether the benefits of the Scientific Advisory Board will be realized, including whether the Board will effectively aid in the advancement and development of ModeX's immunology and oncology focused pipeline as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our relationship with our commercial partners, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts:InvestorsAlliance Advisors IRYvonne Briggs, 310-691-7100ybriggs@ Voss, 310-691-7100bvoss@ ModeX Media Relationsmedia@ 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
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28-04-2025
- Business
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Boehringer's new zongertinib data demonstrate durable and clinically meaningful results in patients with HER2 (ERBB2)-mutant advanced NSCLC
Ingelheim, Germany / Ridgefield, Conn., U.S., April 28, 2025 New data from the Phase Ib Beamion LUNG-1 trial were presented at AACR and simultaneously published in The New England Journal of Medicine Data presented included an objective response rate (ORR) of 71%, with 7% of patients achieving complete responses (CR), and a 96% disease control rate (DCR) Previously unreported results, including median duration of response (DoR) of 14.1 months and median progression-free survival (PFS) of 12.4 months, indicate the potential for zongertinib to impact clinical practice Zongertinib continued to demonstrate a manageable safety profile, with low incidence of grade ≥3 drug-related AEs Boehringer Ingelheim reported new and updated data from the Beamion LUNG-1 trial evaluating zongertinib in previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). The data were featured in the official press program at the American Association for Cancer Research (AACR) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine. 'These data presented at AACR 2025 suggest that zongertinib may offer a new approach to treating patients with non-small cell lung cancer with activating HER2 mutations,' said the trial's coordinating investigator, Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. 'Notably, more than 70% of patients experienced a tumor response, which is highly meaningful for those with this subtype of lung cancer. If approved by the FDA, zongertinib would be the first oral, targeted treatment option that addresses an unmet need for these patients.' Data from the most recent analysis showed durable response and clinically meaningful results with zongertinib in previously treated patients with advanced NSCLC who have HER2 mutations within the tyrosine kinase domain (TKD) (N=75). The ORR was 71% (95% CI: 60-80), with 7% complete response, 64% partial response, and 96% disease control in previously treated patients. Additionally, zongertinib had intracranial activity in previously treated patients (n=27, who were evaluable) with brain metastases, with 41% achieving response and 81% disease control. At AACR 2025, the median DoR of 14.1 and median PFS of 12.4 months were presented for the first time. Itziar Canamasas, Global Head of Oncology at Boehringer Ingelheim, said: 'Zongertinib has the potential to reset the benchmark for patients with HER2-mutant advanced non-small cell lung cancer, a patient population that has historically faced a poor prognosis. At Boehringer, we take cancer care personally; these updated data reaffirm our approach of addressing areas with high unmet need and letting our research guide us to where we can have the biggest impact for patients.' Initial results in patients with advanced NSCLC with HER2 mutations in the TKD, who were previously treated with both platinum-based chemotherapy and subsequent HER2-directed antibody drug conjugates (ADC) (N=31), demonstrated an ORR of 48% (95% CI: 32-65) with 97% (95% CI: 15-52) of patients achieving disease control. An exploratory cohort (n=20) that included previously treated patients with advanced NSCLC with HER2 mutations outside of the TKD demonstrated an investigator-assessed ORR of 30% (95% CI: 15-52) and a DCR of 65% (95% CI: 43-82). This is the largest known dataset of patients with previously treated advanced NSCLC who have HER2 mutations outside the TKD. Both of these data sets were presented at AACR 2025 and are included in The New England Journal of Medicine publication. The data presented at AACR 2025 demonstrated a manageable safety profile for zongertinib with no drug-related deaths, cases of interstitial lung disease (ILD) or cardiotoxicity reported. The most commonly reported adverse event (AE) was grade 1 diarrhea, with low incidence of grade ≥3 drug-related events (17%) in patients with TKD mutations (N=75). Endpoint Patients with TKD mutations (N = 75) Patients with TKD mutations and prior HER2-directed ADC treatment (N = 31) Patients with non-TKD mutations (n = 20) ORR, % 95% CI 71* 60-80 48* 32–65 30** 15-52 CR, % 7* 3* 0** PR, % 64* 45* 30** DCR, % 95% CI 96* 89-99 97* 84-99 65** 43-82 Median DoR 95% CI 14.1 months*** 6.9–NE n/a n/a Median PFS 95% CI 12.4 months*** 8.2–NE n/a n/a *Confirmed response by BICR according to RECIST v1.1 **Confirmed response by investigator review according to RECIST v1.1 *** Median DoR and median PFS are based on Kaplan Meier estimates Lung cancer claims more lives than any other cancer type1 and the incidence is set to increase to over 3 million cases worldwide by 2040.2 NSCLC is the most common type of lung cancer.3 The condition is often diagnosed at a late stage,4 and fewer than 3 in 10 patients are alive five years after diagnosis.5 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives. There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Up to 4% of lung cancers are driven by HER2 mutations (or gene alterations).6 Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.7 Zongertinib is an investigational irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby limiting associated toxicities. This orally administered, targeted therapy was granted FDA Fast Track Designation in 2023, followed by Breakthrough Therapy Designation in the U.S. and China for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations and who have received prior systemic therapy. An application for accelerated approval was granted Priority Review status by the FDA in February 2025. In addition, Japan's Pharmaceuticals and Medical Devices Agency granted Orphan Drug Designation to zongertinib. A recent study has shown pre-clinically that the investigational compound zongertinib has potential for further clinical study in HER2 dependent solid cancers as monotherapy and as concurrent treatment with ADC therapy. In addition, zongertinib is being evaluated in Beamion LUNG-2 (NCT06151574), a global Phase III trial, compared to standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic NSCLC who have activating HER2 TKD mutations. Beamion LUNG-1 (NCT04886804): An open-label, Phase I dose escalation trial, with dose confirmation and expansion, of zongertinib as monotherapy in people with advanced or metastatic solid tumors and NSCLC with activating HER2 alterations. The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumors with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with advanced non-small cell lung cancer with a specific mutation in the HER2 gene. Beamion LUNG-2 is a phase 3, open label, randomized, active-controlled study in patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring HER2 TKD mutations to evaluate zongertinib compared with standard of care. We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim's generational commitment to driving scientific innovation is reflected by the company's robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer's ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at References 1 World Health Organization Cancer Factsheet. (Accessed April 2025). 2 International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: (Accessed August 2024). 3 Zappa C & Mousa Non-small cell lung cancer: current treatment and future advances, Transl Lung Cancer Res. 2016 Jun; 5(3): 288–300. 4 Polanco D et al. Prognostic value of symptoms at lung cancer diagnosis: a three-year observational study. J Thorac Dis 2021;13:1485–1494 5 National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). (Accessed: August 2024). 6 Arcila, M. E. et al. Prevalence, clinicopathologic associations, and molecular spectrum of ERBB2 (HER2) tyrosine kinase mutations in lung adenocarcinomas. Clin. cancer Res. an Off. J. Am. Assoc. Cancer Res. 18, 4910–4918 (2012). 7 Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997.
Yahoo
28-04-2025
- Health
- Yahoo
Boehringer's new zongertinib data demonstrates durable and clinically meaningful results in patients with HER2 (ERBB2)-mutant advanced NSCLC
New data from the Phase Ib Beamion LUNG-1 trial were presented at AACR and simultaneously published in The New England Journal of Medicine Data presented included an objective response rate (ORR) of 71%, with 7% of patients achieving complete responses (CR), and a 96% disease control rate (DCR) Previously unreported results, including median duration of response (DoR) of 14.1 months and median progression-free survival (PFS) of 12.4 months, indicate the potential for zongertinib to impact clinical practice Zongertinib continued to demonstrate a manageable safety profile, with low incidence of grade ≥3 drug-related AEs INGELHEIM, Germany and RIDGEFIELD, Conn., April 28, 2025 /PRNewswire/ -- Boehringer Ingelheim reported new and updated data from the Beamion LUNG-1 trial evaluating zongertinib in previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). The data was featured in the official press program at the American Association for Cancer Research (AACR) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine. "These data presented at AACR 2025 suggest that zongertinib may offer a new approach to treating patients with non-small cell lung cancer with activating HER2 mutations," said the trial's coordinating investigator, Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "Notably, more than 70% of patients experienced a tumor response, which is highly meaningful for those with this subtype of lung cancer. If approved by the FDA, zongertinib would be the first oral, targeted treatment option that addresses an unmet need for these patients." Data from the most recent analysis showed durable response and clinically meaningful results with zongertinib in previously treated patients with advanced NSCLC who have HER2 mutations within the tyrosine kinase domain (TKD) (N=75). The ORR was 71% (95% CI: 60-80), with 7% complete response, 64% partial response, and 96% disease control in previously treated patients. Additionally, zongertinib had intracranial activity in previously treated patients (n=27, who were evaluable) with brain metastases, with 41% achieving response and 81% disease control. At AACR 2025, the median DoR of 14.1 and median PFS of 12.4 months were presented for the first time. Itziar Canamasas, Global Head of Oncology at Boehringer Ingelheim, said: "Zongertinib has the potential to reset the benchmark for patients with HER2-mutant advanced non-small cell lung cancer, a patient population that has historically faced a poor prognosis. At Boehringer, we take cancer care personally; these updated data reaffirm our approach of addressing areas with high unmet need and letting our research guide us to where we can have the biggest impact for patients." Additional analyses of previously treated patients with HER2 mutations demonstrated zongertinib's clinically meaningful results Initial results in patients with advanced NSCLC with HER2 mutations in the TKD, who were previously treated with both platinum-based chemotherapy and subsequent HER2-directed antibody drug conjugates (ADC) (N=31), demonstrated an ORR of 48% (95% CI: 32-65) with 97% (95% CI: 15-52) of patients achieving disease control. An exploratory cohort (n=20) that included previously treated patients with advanced NSCLC with HER2 mutations outside of the TKD demonstrated an investigator-assessed ORR of 30% (95% CI: 15-52) and a DCR of 65% (95% CI: 43-82). This is the largest known dataset of patients with previously treated advanced NSCLC who have HER2 mutations outside the TKD. Both of these data sets were presented at AACR 2025 and are included in The New England Journal of Medicine publication. The data presented at AACR 2025 demonstrated a manageable safety profile for zongertinib with no drug-related deaths, cases of interstitial lung disease (ILD) or cardiotoxicity reported. The most commonly reported adverse event (AE) was grade 1 diarrhea, with low incidence of grade ≥3 drug-related events (17%) in patients with TKD mutations (N=75). AACR 2025 presentation: summary of key efficacy endpoints Endpoint Patients with TKD mutations (N = 75) Patients with TKD mutations and prior HER2-directed ADC treatment (N = 31) Patients with non-TKD mutations (n = 20) ORR, % 95% CI 71* 60-80 48* 32–65 30** 15-52 CR, % 7* 3* 0** PR, % 64* 45* 30** DCR, % 95% CI 96* 89-99 97* 84-99 65** 43-82 Median DoR 95% CI 14.1 months*** 6.9–NE n/a n/a Median PFS 95% CI 12.4 months*** 8.2–NE n/a n/a *Confirmed response by BICR according to RECIST v1.1**Confirmed response by investigator review according to RECIST v1.1*** Median DoR and median PFS are based on Kaplan Meier estimates About non-small cell lung cancer (NSCLC)Lung cancer claims more lives than any other cancer type1 and the incidence is set to increase to over 3 million cases worldwide by 2040.2 NSCLC is the most common type of lung cancer.3 The condition is often diagnosed at a late stage,4 and fewer than 3 in 10 patients are alive five years after diagnosis.5 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives. There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Up to 4% of lung cancers are driven by HER2 mutations (or gene alterations).6 Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.7 About zongertinibZongertinib is an investigational irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby limiting associated toxicities. This orally administered, targeted therapy was granted FDA Fast Track Designation in 2023, followed by Breakthrough Therapy Designation in the U.S. and China for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations and who have received prior systemic therapy. An application for accelerated approval was granted Priority Review status by the FDA in February 2025. In addition, Japan's Pharmaceuticals and Medical Devices Agency granted Orphan Drug Designation to zongertinib. A recent study has shown pre-clinically that the investigational compound zongertinib has potential for further clinical study in HER2 dependent solid cancers as monotherapy and as concurrent treatment with ADC therapy. In addition, zongertinib is being evaluated in Beamion LUNG-2 (NCT06151574)4, a global Phase III trial, compared to standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic NSCLC who have activating HER2 TKD mutations. About the Beamion clinical trial programBeamion LUNG-1 (NCT04886804): An open-label, Phase I dose escalation trial, with dose confirmation and expansion, of zongertinib as monotherapy in people with advanced or metastatic solid tumors and NSCLC with activating HER2 alterations. The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumors with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with advanced non-small cell lung cancer with a specific mutation in the HER2 gene. Beamion LUNG-2 is a phase 3, open label, randomized, active-controlled study in patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring HER2 TKD mutations to evaluate zongertinib compared with standard of care. About Boehringer Ingelheim in Oncology We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim's generational commitment to driving scientific innovation is reflected by the company's robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer's ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. About Boehringer IngelheimBoehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. 1World Health Organization Cancer Factsheet. (Accessed April 2025).2International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: (Accessed August 2024).3Zappa C & Mousa Non-small cell lung cancer: current treatment and future advances, Transl Lung Cancer Res. 2016 Jun; 5(3): 288–300.4Polanco D et al. Prognostic value of symptoms at lung cancer diagnosis: a three-year observational study. J Thorac Dis 2021;13:1485–14945National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). (Accessed: August 2024).6Arcila, M. E. et al. Prevalence, clinicopathologic associations, and molecular spectrum of ERBB2 (HER2) tyrosine kinase mutations in lung adenocarcinomas. Clin. cancer Res. an Off. J. Am. Assoc. Cancer Res. 18, 4910–4918 (2012).7Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997. 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