#London #United Kingdom #Biohaven #Cemiplimab #BHV-1510

Biohaven Unveils Clinical Findings for BHV-1510

Biohaven Ltd., a prominent biopharmaceutical company, recently showcased the clinical safety and efficacy results for its innovative antibody drug conjugate, BHV-1510, at the prestigious 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress held in London from December 10-12, 2025.

This groundbreaking drug, designed for advanced and metastatic cancers, was presented in conjunction with Regeneron's cemiplimab, an anti-PD-1 agent. The study involved participants who had previously undergone treatments, with a noteworthy 87.1% having been exposed to PD-(L)1 agents. At a dosage of 2.5 mg/kg every three weeks, the combination yielded a confirmed objective response rate (ORR) of 72.7%. The breakdown showed a 60% response in non-small cell lung cancer (NSCLC) and a remarkable 100% in endometrial cancer.

Dr. Ida Micaily, Principal Investigator at the Sidney Kimmel Comprehensive Cancer Center, expressed excitement regarding these emerging results, particularly highlighting the substantial early responses in challenging tumor types. Many patients exhibited tumor reduction within just 11.1 weeks of treatment, with some continuing on the therapy for over six months, signifying the potential for durable disease control.

BHV-1510 stands out with its unique safety profile, displaying lower rates of adverse effects compared to traditional Trop2 antibody-drug conjugates. The incidence of hematological toxicities was minimal, with only one case of dose-limiting stomatitis occurring at a higher dose. Importantly, there were no reports of severe complications such as interstitial lung disease, which is often a concern with similar therapies.

The ongoing Phase 1 trial demonstrates BHV-1510's safety and preliminary efficacy, paving the way for its potential use in earlier lines of therapy, especially when combined with checkpoint inhibitors. The study is set against a backdrop of highly challenging treatment landscapes where previous therapies, including anti-PD-1/PD-L1 agents, had failed.

Biohaven continues to enhance its robust portfolio of therapeutic developments, focusing on key areas including oncology, neuroscience, and immunology. Their strategic Ansatz and proprietary drug delivery systems are positioned to revolutionize treatment protocols and improve patient outcomes significantly.

As a biopharmaceutical company at the forefront of innovative drug development, Biohaven aims to apply its findings from this study to future clinical practices, enhancing therapeutic options for patients battling advanced cancer.

In conclusion, the data presented at ESMO 2025 reinforces the promise of BHV-1510 as a powerful tool in the fight against advanced cancers, reflecting Biohaven's commitment to developing life-changing treatments through rigorous research and innovative technologies.