Biohaven Ltd. presented early clinical data for its Trop2 antibody‑drug conjugate BHV‑1510 combined with Regeneron's cemiplimab at the 2025 European Society for Medical Oncology Congress in London. The presentation highlighted a confirmed objective response rate of 72.7 % at the 2.5 mg/kg dose and an overall ORR of 52.2 % across 23 patients.
At the 2.5 mg/kg dose, 60 % of non‑small cell lung cancer patients responded, 100 % of endometrial cancer patients responded—including one complete response—and 50 % of urothelial cancer patients responded. Across all tumor types, the median time to response was 11.1 weeks and 18 patients remained on therapy beyond six months.
Safety data were encouraging, with only one dose‑limiting toxicity—a grade 3 stomatitis—reported at the highest dose. No interstitial lung disease or other severe adverse events were observed, underscoring the manageable safety profile of the BHV‑1510/cemiplimab combination.
These results represent the first clinical evidence of a Trop2‑directed ADC paired with a checkpoint inhibitor in solid tumors, positioning Biohaven in a rapidly expanding immuno‑oncology market. The Trop2 ADC landscape includes competitors such as Gilead, AstraZeneca, and Merck, but Biohaven’s proprietary TopoIx payload and stable linker may offer a differentiated safety and efficacy profile.
Chief Medical Officer Nushmia Khokhar noted that the early Phase 1 data demonstrate “significant clinical activity with minimal toxicities related to the free payload,” while investigator Dr. Ida Micaily highlighted the encouraging responses in heavily pre‑treated patients. The company indicated that the data will inform future development plans and potential partnership discussions.
Biohaven remains a clinical‑stage company with zero revenue and substantial operating losses, but it holds a sizable cash reserve that supports continued development. The positive Trop2 ADC data may attract strategic collaborations or licensing agreements, potentially accelerating the company’s path to commercialization and improving its long‑term financial outlook.
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