- Phase 1b study will evaluate zongertinib and zanidatamab in HER2-positive breast cancer.
- HER2-positive breast cancer accounts for 15-20% of all breast cancers.
- Zongertinib has FDA, CDE, and PMDA approvals for HER2-mutant NSCLC.
- Zanidatamab is in Phase III trials for various cancers.
Clinical Collaboration
Boehringer Ingelheim and Jazz Pharmaceuticals have announced a strategic clinical collaboration to explore a novel combination therapy for HER2-positive breast cancer. This collaboration will initiate a Phase 1b cohort within Boehringer’s ongoing Beamion-BCGC1 trial, evaluating the combination of Boehringer’s zongertinib and Jazz’s zanidatamab.
HER2-Positive Breast Cancer
HER2-positive breast cancer is an aggressive subtype, representing 15–20% of all breast cancers. Despite advancements in HER2-targeted therapies, advanced or metastatic patients face poor five-year survival rates of around 50%. The collaboration aims to improve patient outcomes by combining two differentiated HER2-targeted approaches.
Zongertinib and Zanidatamab
Zongertinib, marketed as HERNEXEOS®, has received FDA accelerated approval in the U.S., CDE conditional approval in China, and PMDA marketing authorization in Japan for HER2-mutant advanced non-small cell lung cancer (NSCLC). It demonstrated a 71% objective response rate in pre-treated patients with HER2-mutant NSCLC. Zanidatamab, marketed as ZIIHERA®, is a bispecific HER2-directed antibody with accelerated FDA approval for HER2-positive biliary tract cancer and is in Phase III trials for various cancers.
Study Objectives
The study aims to generate critical insights into the safety and efficacy of dual HER2 blockade, potentially informing the development of future combination therapies.
