Corvus Pharmaceuticals Inc. (NASDAQ: CRVS) has published Phase 1/1b trial results for its experimental drug soquelitinibe in the journal Blood, the official publication of the American Society of Hematology.
The study evaluated soquelitinibe in 75 patients with various forms of T-cell lymphoma, all of whom had received an average of three prior treatments. Participants were administered twice-daily doses ranging from 100 mg to 600 mg, with the 200 mg twice-daily dose selected for further expansion based on biomarker analyses.
Among the 36 patients receiving the 200 mg dose, six achieved complete responses and three achieved partial responses. In the subgroup of 24 patients with one to three prior treatments, nine patients showed objective responses, including six complete and three partial responses. This subgroup demonstrated a median progression-free survival of 6.2 months and a median overall survival of 28.1 months.
The drug was well tolerated across all dosage levels up to 600 mg twice daily, with no dose-limiting toxicities reported. No cases of myelosuppression or immunosuppression were observed. Soquelitinibe selectively inhibits ITK, promoting a Th1 immune response while blocking Th2 and Th17 differentiation. In vitro studies and patient biomarker analyses indicated an increase in Th1 cells and a reduction in serum IL-5 levels.
Corvus is advancing soquelitinibe into a Phase 3 registration trial in relapsed or refractory peripheral T-cell lymphoma, targeting 150 participants. The trial will compare soquelitinibe to physician’s choice of belinostat or pralatrexate, with progression-free survival as the primary endpoint. Additional Phase 2 trials are underway in atopic dermatitis, with plans to initiate studies in hidradenitis suppurativa and asthma.
The FDA has granted soquelitinibe orphan drug designation for T-cell lymphoma and fast track designation for relapsed or refractory peripheral T-cell lymphoma following at least two prior systemic therapies.
