Corvus’ Soquelitinib Shows Durable Activity in T-Cell Lymphoma, Supporting Phase 3 Development

Corvus Pharmaceuticals reported publication of final Phase 1/1b data (NCT03952078) for soquelitinib in Blood, the journal of the American Society of Hematology. The study enrolled 75 patients with multiple T-cell lymphoma subtypes, including PTCL, T follicular helper cell lymphoma, natural killer T-cell lymphoma, cutaneous T-cell lymphoma, anaplastic large cell lymphoma and adult T-cell lymphoma/leukemia.

Patients had received a median of three prior therapies, with a range of one to 18. Only 31% had achieved an objective response to their most recent treatment, highlighting the refractory nature of the study population.

In dose escalation, patients received soquelitinib at 100, 200, 400 or 600 mg twice daily. Biomarker analyses showed complete ITK target occupancy at doses of 200 mg or higher, supporting selection of 200 mg twice daily for dose expansion.

Among 36 patients treated at 200 mg twice daily, investigators observed objective and durable responses, including six complete responses. The subgroup with one to three prior therapies showed the strongest activity: nine of 24 patients responded, including six complete and three partial responses. Median progression-free survival was 6.2 months, with 30% of patients remaining progression-free at 18 months. Median overall survival reached 28.1 months, with 67% of patients alive at 24 months.

Selective ITK Inhibition Links Biology to Clinical Activity

Soquelitinib is an oral small-molecule inhibitor of interleukin-2-inducible T-cell kinase (ITK), an enzyme expressed predominantly in T cells that regulates immune-cell differentiation and function. Its inhibition promotes Th1 differentiation while suppressing Th2 and Th17 development and associated cytokine production.

The Blood publication provides evidence that this immunologic effect occurs in patients. Blood biomarkers showed increased Th1 cells and reduced serum IL-5, while paired tumor biopsies from six patients demonstrated increased intratumoral Th1 cells by day eight. These findings support a mechanism involving both direct effects on malignant cells and changes to the tumor microenvironment that enhance antitumor immune activity.

 Safety Supports Continued Development

Soquelitinib was tolerated across doses up to 600 mg twice daily, with no dose-limiting toxicities or significant adverse events reported in the study. Notably, investigators reported no myelosuppression or immunosuppression.

Richard A. Miller, M.D., Corvus’ co-founder, president and CEO, said the durability of responses and overall survival findings provide the rationale for advancing the program in relapsed/refractory PTCL. He also pointed to the clinical and biomarker findings as support for testing ITK inhibition in immune and inflammatory diseases.

Phase 3 PTCL Trial Underway

Corvus is enrolling a randomized Phase 3 trial (NCT06561048) of soquelitinib in relapsed/refractory PTCL. The study plans to enroll 150 patients and compares soquelitinib with physician’s choice of belinostat or pralatrexate, with progression-free survival as the primary endpoint.

The program also includes a Phase 2 trial in atopic dermatitis, while planned studies will evaluate soquelitinib in hidradenitis suppurativa and asthma. The FDA has granted the drug Orphan Drug Designation for T-cell lymphoma and Fast Track designation for adults with relapsed or refractory PTCL after at least two lines of systemic therapy.

The next key test will be whether the response durability and survival signal observed in the early-stage study translate into a randomized Phase 3 benefit in relapsed/refractory PTCL, where treatment options remain limited and outcomes are poor.

Reference

Corvus Pharmaceuticals Announces Publication in Blood of Final Phase 1 Data from the Soquelitinib Phase 1/1b T Cell Lymphoma Trial | Corvus Pharmaceuticals