clinical trial

Iovance Biotherapeutics announced five-year follow-up data for Amtagvi (lifileucel) in advanced melanoma. Results from the Phase 2 trial show deep, durable responses with one-third of patients maintaining ongoing responses after five years. Median overall survival was 13.9 months, with a five-year survival rate of 19.7%. The therapy, already FDA-approved, provides a new treatment option for patients with advanced melanoma who progressed after prior therapies.

Trevi Therapeutics will release topline results from its Phase 2b CORAL trial of Haduvio, an investigational therapy for chronic cough in idiopathic pulmonary fibrosis (IPF). A conference call and webcast will be held on June 2nd, 2025, at 8:30 a.m. ET to discuss the findings. Haduvio targets the cough reflex arc, and initial trials show promising reduction in cough frequency. The results are highly anticipated as there is currently no approved therapy for IPF chronic cough. Further information can be found on the company’s website.

Bicara Therapeutics presented positive Phase 1/1b trial data for ficerafusp alfa, a bifunctional antibody, combined with pembrolizumab in first-line recurrent/metastatic head and neck cancer. The results, particularly in HPV-negative patients, showed significant antitumor activity, including a median duration of response of 21.7 months, median overall survival of 21.3 months, and a two-year overall survival rate of 46%. The data supports the advancement of the FORTIFI-HN01 pivotal trial.

Innovent Biologics announced positive Phase 1/2 data for IBI363, a PD-1/IL-2α-bias bispecific antibody, at ASCO 2025. The study showed promising results in immunotherapy-resistant acral and mucosal melanoma (“cold tumors”), demonstrating a 23.3% confirmed objective response rate and 14.8 months median overall survival. A Phase 2 registration trial for IBI363 is underway, offering a potential breakthrough for advanced melanoma treatment.

Biohaven launched a global Phase 2/3 trial for BHV-8000, a first-in-clinic, brain-penetrant TYK2/JAK1 inhibitor, targeting neuroinflammation in Parkinson’s disease. The drug aims to address the underlying cause of disease progression, with no existing disease-modifying therapies currently available. The trial will enroll 550 patients across 13 countries to assess efficacy and safety, utilizing innovative endpoints. BHV-8000 has shown safety and tolerability, with robust brain penetration, representing a potential breakthrough in treating neurodegenerative diseases.