- Phase 1b study to evaluate combination of zongertinib and zanidatamab in HER2-positive breast cancer patients
Ingelheim, Germany- 12 January, 2026 - Boehringer Ingelheim today announced a strategic clinical collaboration with Jazz Pharmaceuticals (Nasdaq: JAZZ) on the exploration of a novel combination therapy for patients with HER2-positive breast cancer. As part of this collaboration, the partners will initiate a Phase 1b cohort within Boehringer's ongoing Beamion-BCGC1 trial, evaluating the combination of Boehringer's zongertinib and Jazz's zanidatamab in breast cancer.
Despite significant progress in HER2-targeted therapies, HER2-positive breast cancer remains an aggressive subtype, accounting for approximately 15-20% of all breast cancers. Advanced or metastatic patients still have poor five-year survival rates, around 50%. This collaboration aims to improve patient outcomes by combining two differentiated HER2-targeted approaches, potentially offering a new therapeutic option for patients.
"At Boehringer Ingelheim, we are committed to pushing the boundaries of science to deliver innovative solutions for patients with high unmet need," said Itziar Canamasas, Global Head of Oncology at Boehringer Ingelheim. "By combining zongertinib's precision approach with zanidatamab's unique bispecific antibody mechanism, we aim to unlock new possibilities for patients living with HER2-expressing breast cancer."
Amal Melhem-Bertrandt, VP, Oncology Therapy Area Head and Zanidatamab Global Clinical Lead at Jazz Pharmaceuticals., said, "This research collaboration with Boehringer Ingelheim is centered in our shared vision to transform treatment paradigms in HER2-expressing breast cancer through the investigation of this novel HER2-targeted combination therapy, as well as possible opportunities to advance outcomes in multiple tumor types."
HERNEXEOS (zongertinib tablets) recently received FDA (accelerated) approval in the U.S., CDE (conditional) approval in China, and PMDA marketing authorization in Japan as the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). In the Beamion LUNG-1 trial, zongertinib demonstrated an objective response rate (ORR) of 71% specifically in pre-treated patients with HER2-mutant NSCLC, along with durable responses. Zongertinib is also under investigation in ongoing clinical trials for various HER2-driven tumors.
ZIIHERA (zanidatamab), a bispecific HER2-directed antibody, has received accelerated approval from the U.S. FDA for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. Further, it is currently in Phase III trials for GEA, BTC and metastatic breast cancer, and is also being investigated in earlier lines of therapy in other tumor types.
The companies anticipate that this study will generate critical insights into the safety and efficacy of dual HER2 blockade and inform the development of a potential future combination therapy.
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 www.boehringer-ingelheim.com.
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