Corvus Pharmaceuticals to Present New Phase 1/1b Soquelitinib Data for T Cell Lymphoma

On March 20, 2025, Corvus Pharmaceuticals, Inc. shared new insights from its Phase 1/1b clinical trial on soquelitinib, a treatment targeting T cell lymphoma (TCL). This announcement coincided with the 16th Annual T-Cell Lymphoma Forum held in San Diego, California.

Richard A. Miller, M.D., the president and CEO of Corvus Pharmaceuticals, expressed optimism about the trial results, noting the significant anti-tumor activity demonstrated by soquelitinib among the patients treated. He highlighted the promising outcomes, including high complete response rates, extended progression-free survival, and an impressive rate of 18-month progression-free survival. These results are considered superior to existing treatments such as belinostat and pralatrexate. Furthermore, the trial indicated that soquelitinib might enhance T cell function and anti-tumor immunity by reducing T cell exhaustion, as evidenced by analysis of blood samples from participating patients.

The promising data from this phase of the trial has spurred the initiation of a registrational Phase 3 trial, enrolling patients with relapsed peripheral T cell lymphoma (PTCL) across multiple sites in the United States, Canada, and Australia. Additionally, another Phase 1 trial investigating soquelitinib for atopic dermatitis is expected to yield results in the second quarter of 2025.

John Reneau, MD, PhD, a hematologist from The Ohio State University Comprehensive Cancer Center, is set to present the findings at the forum. His presentation will cover the selective ITK inhibition in treating PTCL and will include both oral and poster presentations highlighting the outcomes and mechanisms identified in the Phase 1 trial.

The trial enrolled 25 patients at the optimal dose of 200 mg twice daily, with 23 patients meeting the eligibility criteria for the ongoing Phase 3 trial based on previous treatments. Among these 23 patients, nine exhibited objective responses, comprising six complete responses and three partial responses. The median duration of response was recorded at 17.2 months, with three patients remaining on therapy beyond 14 months. The estimated median progression-free survival was 6.2 months, and the 18-month progression-free survival rate stood at 30%. These figures are favorable compared to existing treatments.

Peripheral blood samples collected during the trial showed that the majority of patients experienced a reduction in T cell exhaustion markers after 21 days of treatment, suggesting improved functionality of T cells. The drug was generally well-tolerated, with no significant safety concerns or need for dose adjustments reported.

This success in early trials has led Corvus Pharmaceuticals to advance to a Phase 3 clinical trial focusing on patients with relapsed PTCL. This trial aims to enroll 150 participants and will compare soquelitinib to the physician’s choice between belinostat and pralatrexate. The primary focus of this study is progression-free survival. Notably, there are currently no fully approved treatments for relapsed PTCL, making this trial pivotal. The FDA has granted Orphan Drug Designation to soquelitinib for TCL treatment and Fast Track designation for treating adult patients with relapsed or refractory PTCL.

Peripheral T cell lymphoma represents a varied group of malignancies, accounting for a significant portion of non-Hodgkin’s lymphomas, particularly in Asia and South America. Standard treatments typically involve combination chemotherapy, but the chances of relapse or non-response are high. PTCL often manifests in mature helper T cells with various genetic mutations and frequently involves viral infections.

Soquelitinib, previously known as CPI-818, is an oral small molecule drug designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), a crucial enzyme in T cell and NK cell function. This drug promotes Th1 helper cell differentiation while inhibiting Th2 and Th17 cells, which are involved in autoimmune and allergic diseases. The therapeutic potential of soquelitinib lies in its ability to shift T cell differentiation, offering a promising avenue for both cancer treatment and the management of autoimmune conditions.

Corvus Pharmaceuticals continues to innovate in the field of ITK inhibition, aiming to establish new immunotherapy strategies for various cancers and immune disorders. Their focus remains on advancing soquelitinib and other promising candidates in their pipeline.