1. BHV-1510 shows 60% response in NSCLC and 100% in endometrial cancer. 2. Low adverse events reported, emphasizing safety of BHV-1510. 3. Study suggests durable responses in advanced cancer patients. 4. Early efficacy in patients with prior PD-1/PD-L1 exposure is promising. 5. Biohaven aims to leverage clinical advantages for future therapies.
FAQ
Why Bullish?
The positive clinical data suggests a high potential for revenue generation which can drive stock prices up. Historically, similar announcements have led to immediate stock price increases.
How important is it?
The article discusses vital clinical results directly linked to BHV-1510, indicating potential market success. As investors prioritize efficacy data, this could encourage buying activity.
Why Long Term?
Successful clinical trials and potential market approval can lead to sustained growth. Companies often see significant stock appreciation as therapies move toward commercialization.
Biohaven Unveils Promising Data for BHV-1510 at ESMO Immuno-Oncology Congress
Biohaven Ltd. (NYSE: BHVN) has revealed significant clinical safety and efficacy data for its investigational drug, BHV-1510, during the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress held from December 10 to 12 in London, United Kingdom. This next-generation Trop2 antibody drug conjugate (ADC), combined with Regeneron’s anti-PD-1 therapy, cemiplimab, showed promising early results for advanced/metastatic cancers.
Key Efficacy Results
At a dose of 2.5 mg/kg administered every three weeks (Q3W) alongside cemiplimab, BHV-1510 achieved a confirmed objective response rate (ORR) of 72.7%. The breakdown of responses included:
- NSCLC: 3 out of 5 patients (60%) responded
- Endometrial Cancer: 4 out of 4 patients (100%) achieved a complete response
- Urothelial Cancer: 1 out of 2 patients (50%) responded
Overall, of the 23 evaluable patients treated, the confirmed ORR was 52.2%, with considerably promising outcomes observed across varied tumor types.
Safety Profile Highlights
The Phase 1 trial noted low rates of adverse events associated with the unconjugated payload, which included:
- 12.9% incidence of Grade ≥3 neutrophil count decrease
- 6.5% occurrence of Grade ≥3 treatment-emergent diarrhea
- 59.1% incidence of Grade ≥3 oral mucositis/stomatitis in the Q3W regimen
Notably, there were no cases of interstitial lung disease and no patients discontinued due to adverse events. This differentiates BHV-1510's safety profile from previous Trop2 ADCs, underscoring its potential for wider therapeutic application.
Clinical Insights from Researchers
Principal Investigator Dr. Ida Micaily, M.D., M.S. of Sidney Kimmel Comprehensive Cancer Center at Jefferson, commented, “The early data we are witnessing is encouraging, especially considering the difficult-to-treat tumors and the patients’ history of prior therapies, including other PD-(L)1 agents. The potential for durable disease control with patients remaining on therapy past six months is particularly promising.”
Study Population and Dosage
The study included participants with a median of two prior lines of therapy. A significant majority (87.1%) had past exposure to PD-(L)1 therapies, with many receiving it as their last treatment. BHV-1510 was well tolerated, achieving maximum doses of 2-2.75 mg/kg Q3W without reaching the maximum tolerated dose.
Future Considerations for BHV-1510
Dr. Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, emphasized the drug's potential to be used earlier in treatment lines alongside checkpoint inhibitors, based on its promising preliminary efficacy and safety profile.
As research progresses for BHV-1510, further data and results will be critical for understanding its role in oncology.
Presentation Details
The poster detailing these findings, titled "Phase 1 clinical trial of BHV-1510," will be presented on December 10, 2025, from 5:15-6:30 PM GMT. More information will be available on the Biohaven website following the conference.
About Biohaven
Biohaven focuses on developing transformative therapies across multiple therapeutic areas, including oncology, neuroscience, and immunology. The company's advanced therapeutics and proprietary drug development platforms position it for significant contributions to medical innovation.