LONDON and NEW HAVEN, Conn., Dec. 11, 2025 — Biohaven Ltd. presented clinical safety and efficacy data for BHV-1510 at the 2025 ESMO Immuno-Oncology Congress, reporting early activity and a manageable safety profile for the Trop2-directed antibody–drug conjugate (ADC) in combination with Regeneron’s anti-PD-1 agent cemiplimab.
At a 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 that dose included 3 of 5 patients (60%) with non–small cell lung cancer (NSCLC), 4 of 4 (100%) with endometrial cancer, including a complete response, and 1 of 2 (50%) with urothelial cancer. Among 23 efficacy-evaluable participants treated across dose levels, the confirmed ORR was 52.2%: 6 of 14 (42.9%) in NSCLC, 4 of 6 (66.7%) in endometrial cancer, and 1 of 2 (50%) in urothelial cancer. A confirmed response was also reported in a participant with triple-negative breast cancer. Median time to response was 11.1 weeks, and 18 participants remained on study treatment at the clinical cutoff of October 10, 2025.
The trial population was pretreated, with a median of two prior lines of therapy for advanced/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 of Grade 3 stomatitis occurred at 2.75 mg/kg Q3W. As of the cutoff date, 31 participants had received the combination, with BHV-1510 doses ranging from 2–2.75 mg/kg Q3W and 1.25–1.5 mg/kg on a D1D8Q3W schedule; cemiplimab was administered at 350 mg Q3W.
BHV-1510 showed a differentiated safety profile relative to other Trop2 ADCs. Hematologic toxicity rates were low and manageable, with neutrophil count decreases reported in 12.9% of participants (Grade ≥3, 6.5%). Treatment-emergent diarrhea occurred in 6.5% (no Grade ≥3 events), and alopecia in 9.7%. The most frequent toxicity was oral mucositis/stomatitis: 59.1% overall (Grade ≥3, 22.7%) in the Q3W regimen and 33.3% overall (Grade ≥3, 11.1%) in the D1D8Q3W regimen; investigators described this as a manageable class effect. There were no cases of interstitial lung disease and no participant discontinued treatment due to an adverse event. Treatment-emergent serious adverse events were reported in four participants and were not considered related to study treatment.
Pharmacokinetic analyses indicated a favorable profile, with low concentrations of unconjugated payload and a payload-to-ADC molar ratio below 1%, suggesting high stability of the ADC in circulation.
Principal investigator Ida Micaily, M.D., M.S., of the Sidney Kimmel Comprehensive Cancer Center at Jefferson said the responses observed in patients previously treated with PD-1/PD-L1 agents were encouraging and noted several patients remained on therapy beyond six months. Nushmia Khokhar, M.D., Biohaven’s chief medical officer of oncology, highlighted the early efficacy and differentiated safety profile enabled by the company’s TopoIx payload and linker technology.
The data were presented as Poster 252P, “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,” at the ESMO Immuno-Oncology Congress on December 10, 2025. The poster will be available on Biohaven’s website following the conference.
Biohaven is a biopharmaceutical company focused on therapeutic development in immunology, neuroscience and oncology, advancing clinical and preclinical programs across several proprietary platforms.
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