LONDON and NEW HAVEN, Conn., Dec. 11, 2025 — Biohaven Ltd. reported Phase 1 data showing early clinical activity and a favorable safety profile for BHV-1510, a next-generation Trop2-directed antibody-drug conjugate (ADC) incorporating a TopoIx payload, given in combination with Regeneron’s anti-PD-1 cemiplimab.
At the BHV-1510 dose of 2.5 mg/kg every three weeks (Q3W) plus cemiplimab, the confirmed objective response rate (ORR) was 72.7%. Confirmed responses at this dose included 3/5 (60%) in non–small cell lung cancer (NSCLC), 4/4 (100%) in endometrial cancer (including one complete response), and 1/2 (50%) in urothelial cancer. Across all BHV-1510 dose levels, in 23 efficacy-evaluable participants treated with the combination as of the October 10, 2025 clinical cutoff, the confirmed ORR was 52.2%, with responses in 6/14 (42.9%) NSCLC patients, 4/6 (66.7%) endometrial cancer patients, and 1/2 (50%) urothelial cancer patients. A confirmed response was also reported in a participant with triple-negative breast cancer. The median time to response was 11.1 weeks, and 18 participants remained on study treatment at the cutoff, with several on therapy beyond six months.
The study population had a median of two prior lines of therapy for advanced or metastatic disease; 87.1% had prior PD-(L)1 exposure and 51.6% received a PD-(L)1 agent as their most recent therapy. The maximum tolerated dose was not reached. One dose-limiting toxicity (Grade 3 stomatitis) occurred at 2.75 mg/kg Q3W. A total of 31 participants received the BHV-1510 and cemiplimab combination, with BHV-1510 doses ranging from 2–2.75 mg/kg Q3W and 1.25–1.5 mg/kg on a D1/D8 Q3W schedule. Cemiplimab was administered at 350 mg Q3W.
BHV-1510 was generally well tolerated with a safety profile described as differentiated from other Trop2 ADCs. Neutrophil count decreases occurred in 12.9% of participants overall, with Grade ≥3 events in 6.5%. Treatment-emergent diarrhea occurred in 6.5% (no Grade ≥3 events). Alopecia was reported in 9.7% of participants. The most frequent toxicity was oral mucositis/stomatitis: for the Q3W regimen, all-grade 59.1% and Grade ≥3 22.7%; for the D1/D8 Q3W regimen, all-grade 33.3% and Grade ≥3 11.1%. There were no cases of interstitial lung disease and no participants discontinued treatment because of adverse events. Treatment-emergent serious adverse events were reported in four participants and were not attributed to the study treatment.
Pharmacokinetic analyses indicated low concentrations of unconjugated payload and a payload-to-ADC molar ratio below 1%, suggesting high ADC stability in circulation.
“We are encouraged by these early responses in difficult-to-treat tumors, including in patients previously treated with PD-1/PD-L1 agents, and by patients remaining on therapy beyond six months,” said Ida Micaily, M.D., M.S., Principal Investigator at Sidney Kimmel Comprehensive Cancer Center at Jefferson. Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, said the data support further evaluation of BHV-1510, particularly in combination with checkpoint inhibitors.
Poster 252P, titled “Phase 1 clinical trial of BHV-1510, a next generation Trop2 ADC, in combination with the PD-1 monoclonal antibody, cemiplimab in patients with advanced solid tumors,” was presented at the 2025 ESMO Immuno-Oncology Congress on December 10, 2025. The poster will be available on Biohaven’s Posters and Presentations page after the conference.
About Biohaven
Biohaven is a biopharmaceutical company focused on discovering, developing and commercializing treatments in immunology, neuroscience and oncology. The company’s programs include Kv7 ion channel modulation for neurological disorders, MoDE™ and TRAP™ extracellular protein degradation platforms for immunological diseases, and treatments targeting the myostatin-activin pathway for neuromuscular and metabolic diseases. For more information, visit www.biohaven.com.
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