South San Francisco-based Corvus Pharmaceuticals Inc. (NASDAQ: CRVS) announced the publication of soquelitinib clinical data in Blood, the journal of the American Society of Hematology, detailing results from a Phase 1/1b trial in patients with relapsed or refractory peripheral T cell lymphoma (PTCL).
The open-label study enrolled 75 patients who had received a median of three prior therapies, administering twice-daily doses ranging from 100 mg to 600 mg. A 200 mg twice-daily regimen was selected for dose expansion based on biomarker analyses. In the 36-patient cohort receiving this dose, six patients achieved complete responses and three achieved partial responses. Among the subgroup of 24 patients with one to three prior therapies, nine patients responded objectively, including six complete responses and three partial responses.
Median progression-free survival in this subgroup reached 6.2 months, while median overall survival extended to 28.1 months. The treatment was generally well tolerated across all dose levels up to 600 mg twice daily, with no dose-limiting toxicities, myelosuppression, or immunosuppression reported. Soquelitinib operates through selective ITK inhibition, promoting Th1 cell skewing while suppressing Th2 and Th17 differentiation, supported by in vitro studies and patient biomarker analyses that showed increased Th1 cells and reduced serum IL-5 levels.
Corvus is advancing soquelitinib in a Phase 3 registration trial for relapsed or refractory PTCL, enrolling 150 patients in a randomized controlled study comparing soquelitinib to physician’s choice of belinostat or pralatrexate, with progression-free survival as the primary endpoint. The company also plans Phase 2 trials in atopic dermatitis, hidradenitis suppurativa, and asthma. Regulatory progress includes orphan drug designation for T cell lymphoma and fast track designation for relapsed or refractory PTCL after at least two prior systemic therapies.
Corvus Pharmaceuticals’ shares closed at $14.56 on August 25, up 3.34%, and rose further to $14.76 in after-hours trading following the publication.
