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Yahoo
6 hours ago
- 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
Yahoo
28-04-2025
- Business
- Yahoo
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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Hamilton Spectator
28-04-2025
- Business
- Hamilton Spectator
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 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). ORR, % 95% CI 71* 60-80 48* 32–65 30** 15-52 DCR, % 95% CI 96* 89-99 97* 84-99 65** 43-82 Median DoR 95% CI 14.1 months*** 6.9–NE Median PFS 95% CI 12.4 months*** 8.2–NE *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.
