Corvus announced new interim data from Phase 1/1b trial of soquelitinib

Corvus Pharmaceuticals announced new interim data from its Phase 1/1b clinical trial of soquelitinib in patients with relapsed PTCL. Soquelitinib demonstrated durable anti-tumor activity, evidenced by progression free survival, duration of response and overall survival rates that exceed current standard of care therapies for patients with relapsed PTCL. The data continues to support the advancement of soquelitinib into a Phase 3 registrational clinical trial in PTCL. Updated interim data as of November 27, 2023: A total of 36 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose, including 21 evaluable patients who would be eligible in the planned registrational Phase 3 clinical trial based on greater than or equal to1 and less than or equal to3 prior therapies and 11 evaluable in the corresponding ineligible population based on over 3 prior therapies. In the Phase 1/1b clinical trial, the median number of prior therapies was 2 for the eligible patient population and 6 for the ineligible patient population. The rationale for enrolling these patient populations and the stratification analysis was to confirm the eligibility requirements planned for Phase 3 clinical trial. For the eligible patient population, objective responses were seen in 7 of 21 patients with disease control in 12 of 21 patients. The stable disease group included 5 patients who achieved tumor reductions that did not meet the criteria for a PR, with two of these patients continuing on therapy. For the eligible patient population, the median duration of response for the seven patients with objective response by Lugano criteria was 14.5+ months; three of these patients continued on therapy. A total of five patients in the eligible patient population remained on therapy, including one patient with a CR at 21+ months, two patients with a PR at 3+ and 8+ months, and 2 with stable disease at 3+ and 5+ months. Kaplan Meier estimated median progression free survival was 6 months for the eligible patient population. Kaplan Meier estimated overall survival at 2 years was 77% for all 36 patients. One additional eligible patient, not shown here, was treated at a higher dose and achieved a PR. While in PR, this patient went on to receive a bone marrow transplant and achieved a CR, which has continued as of the data cutoff without any further therapy for 2+ years. For the ineligible patient population, no objective responses were seen in 11 evaluable patients.