Jazz Pharmaceuticals and Boehringer Ingelheim have launched a new clinical collaboration to evaluate a combination of Boehringer’s oral HER2 inhibitor zongertinib and Jazz’s bispecific antibody zanidatamab in patients with HER2‑positive breast cancer. The partnership will add a Phase 1b cohort to Boehringer’s ongoing Beamion‑BCGC1 study, enrolling up to 30 patients with advanced or metastatic disease to assess safety, tolerability and preliminary efficacy of the dual HER2 blockade.
The Phase 1b cohort will enroll patients who have progressed on standard HER2‑targeted therapy. Primary endpoints include dose‑limiting toxicity and recommended phase 2 dose, while secondary endpoints will evaluate objective response rate, duration of response and progression‑free survival. The cohort is expected to begin enrollment in the first quarter of 2026 and to report initial safety data by the end of 2026.
HER2‑positive breast cancer accounts for roughly 15‑20% of all breast cancers and represents a market that is projected to grow from $10.96 billion in 2025 to $12.94 billion by 2032, a CAGR of 2.4%. The combination of a small‑molecule TKI and a bispecific antibody offers a novel mechanism that could improve response rates and durability in a population that still faces limited options after progression on trastuzumab‑based regimens.
For Jazz, the collaboration expands an oncology portfolio that already includes the accelerated‑approval bispecific zanidatamab for biliary tract cancer and the recent acquisition of Chimerix, positioning the company to capture a share of the expanding HER2‑positive market. Boehringer, which reported EUR 14.0 billion in net sales in the first half of 2025, gains a new indication for its accelerated‑approved zongertinib, potentially extending the drug’s reach beyond HER2‑mutant non‑small‑cell lung cancer.
Management emphasized the strategic fit of the partnership. Boehringer’s Itziar Canamasas said the combination “leverages zongertinib’s precision approach with zanidatamab’s unique bispecific mechanism to unlock new possibilities for patients with HER2‑expressing breast cancer.” Jazz’s Amal Melhem‑Bertrandt added that the collaboration “centers on a shared vision to transform treatment paradigms in HER2‑positive breast cancer through a novel HER2‑targeted combination, with potential to advance outcomes across multiple tumor types.”
The collaboration signals both companies’ confidence in the dual HER2 blockade strategy and positions them to compete in a market that is still evolving with new antibody‑drug conjugates and tyrosine kinase inhibitors. By combining complementary technologies, the partnership aims to address the unmet need for more effective therapies in advanced HER2‑positive disease and could open a new revenue stream for both firms as the market continues to grow.
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