On December 11, 2025 Biohaven Ltd. (NYSE: BHVN) reported that it presented clinical safety and efficacy data for BHV-1510 at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress, taking place from December 10-12, 2025, in London, United Kingdom. The presentation highlights Biohaven’s novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, in combination with Regeneron’s anti-PD-1 cemiplimab demonstrating efficacy and manageable safety across several tumors.

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At the BHV-1510 dose of 2.5 mg/kg Q3W in combination with cemiplimab, confirmed ORR was 72.7%. Confirmed responses were observed in 3/5 (60%) in NSCLC, 4/4 (100%) in endometrial cancer, which included a complete response, and 1/2 (50%) in urothelial cancer (Fig.1). In all 23 efficacy evaluable participants treated with BHV-1510 in combination with cemiplimab across dose levels, as of the clinical cutoff date (October 10, 2025) the confirmed objective response rate (ORR) was 52.2%, with confirmed objective responses in 6/14 (42.9%) in NSCLC, 4/6 (66.7%) in endometrial cancer, and 1/2 (50%) in urothelial cancer (Fig. 2). A confirmed response was reported in the participant with triple negative breast cancer. The majority of participants had tumor reduction on their first scan, with a median time to response of 11.1 weeks. Participants remain on study at 6 months and beyond, 18 participants continue on the study treatment at time of the clinical cutoff date (Fig.3).

Ida Micaily, M.D., M.S., Principal Investigator and Assistant Professor at Sidney Kimmel Comprehensive Cancer Center at Jefferson stated, "We are excited by this emerging data and the potential synergy of BHV-1510 with cemiplimab. The early responses we are observing in these difficult-to-treat tumors—despite patients having received prior therapies, including other PD-1/PD-L1 agents—are particularly encouraging. We also have patients remaining on therapy beyond six months, suggesting the potential for durable disease control."

In the population studied, the median prior lines of therapy for advanced/metastatic disease were two and the majority (87.1%) had prior PD-(L)1 exposure with 16 participants (51.6%) receiving a PD-(L)1 as the most recent treatment prior to receiving study treatment. The maximum tolerated dose was not reached and only one participant had a dose limiting toxicity of stomatitis (Grade 3) at the 2.75 mg/kg Q3W dose. As of the clinical cutoff date, a total of 31 participants were treated with the combination of BHV-1510 and cemiplimab, with BHV-1510 doses ranging from 2-2.75 mg/kg Q3W and 1.25-1.5 mg/kg D1D8Q3W. Cemiplimab was given at 350 mg Q3W.

Across all doses BHV-1510, was generally well tolerated with a safety profile differentiated from other Trop-2 ADCs. The rate of neutrophil count decrease was low and manageable; all Grade (Grade ≥3), 12.9% (6.5%). Similarly, the rates of treatment emergent diarrhea and alopecia were low; all Grade (Grade ≥3), 6.5% (0) and 9.7% respectively. The most frequent toxicity observed was oral mucositis/stomatitis all Grade (Grade ≥3), 59.1% (22.7%) in the Q3W regimen and all Grade (Grade ≥3), 33.3% (11.1%) in the D1D8Q3W regimen. This is a well-known class effect which is manageable. Importantly, there were no cases of interstitial lung disease, and no participants discontinued treatment due to an adverse event. Treatment emergent SAEs were reported in 4 participants, none of which were related to the study treatment. The pharmacokinetic profile for BHV-1510 was favorable, the unconjugated payload concentration was low with a payload-to-ADC molar ratio < 1%, indicating that ADC was highly stable in the circulation.

Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "Continued preliminary clinical data with BHV-1510 in patients who have received and progressed on standard-of-care treatment, including prior anti-PD1/PDL1 therapy, are highly encouraging. These findings—together with the early promising efficacy, differentiated safety profile, lack of payload-related toxicity, enabled by our novel TopoIx payload and stable linker technology—underscores the potential for BHV-1510 to move into earlier lines of therapy, in particular with checkpoint inhibitor combinations, for these challenging tumor types."

Poster Presentation Information:

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.
Date/Time: Wednesday, December 10, 2025, 5:15-6:30 pm GMT

The poster will be available on the Posters and Presentations page after the conference at www.biohaven.com.

(Press release, Biohaven Pharmaceutical, DEC 11, 2025, View Source [SID1234661378])