Corvus Pharma Begins Phase 3 Trial of Soquelitinib for Relapsed/Refractory Peripheral T-Cell Lymphoma

Corvus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical firm, has launched a Phase 3 clinical trial for soquelitinib, a potential treatment for patients suffering from relapsed or refractory peripheral T-cell lymphoma (PTCL). This registrational study aims to ascertain the efficacy and safety of soquelitinib compared to standard chemotherapy treatments.

At the heart of the trial is a randomized, controlled study involving approximately 150 patients who have previously undergone one to three lines of therapy without success. Participants will be divided equally to receive either a 200mg dose of soquelitinib twice daily or standard chemotherapy options, including belinostat or pralatrexate. The primary goal of the study is to measure progression-free survival, with secondary objectives including overall survival, objective response rate, and duration of response. The trial will be conducted across 40 sites in the United States, Canada, Australia, and South Korea.

Dr. Richard A. Miller, the co-founder, president, and CEO of Corvus, emphasized the significance of this trial for both the company and patients battling PTCL. He highlighted soquelitinib’s unique mechanism of action, which involves selective inhibition of ITK (interleukin-2-inducible T cell kinase), a vital enzyme for T cell and natural killer cell functions. This innovative approach holds promise not only for T cell lymphomas but also for solid tumors and a variety of immune diseases.

Dr. Swaminathan P. Iyer, the principal investigator of the study and a professor at The University of Texas MD Anderson Cancer Center, expressed enthusiasm about the trial. He noted that earlier trials had shown soquelitinib to be well-tolerated with significant anti-tumor activity in patients with advanced disease. According to Dr. Iyer, traditional chemotherapy has not yielded lasting remissions and often comes with considerable toxicity. Given the scarcity of new treatment options for PTCL, soquelitinib could potentially offer a more effective and safer alternative.

Corvus Pharmaceuticals has been at the forefront of developing ITK inhibitors as a novel approach to immunotherapy, targeting a wide range of cancers and immune diseases. Apart from soquelitinib, which is their lead product candidate, the company is also developing other clinical-stage drugs for various cancer indications.

Peripheral T-cell lymphoma is a diverse group of malignancies that accounts for about 10% of non-Hodgkin’s lymphomas in Western countries, with higher prevalence rates in parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. Standard initial treatment involves combination chemotherapy, but approximately 75% of patients either do not respond or relapse within the first two years. For relapsed cases, current chemotherapy treatments offer poor outcomes, with median progression-free survival ranging from three to four months and overall median survival between six to twelve months.

Soquelitinib, an investigational oral small molecule drug, selectively inhibits ITK. Interim results from a Phase 1/1b clinical trial demonstrated that soquelitinib could induce tumor responses in patients with advanced, refractory T cell malignancies. Additionally, soquelitinib is being tested in a Phase 1 trial for atopic dermatitis. The drug’s immunological effects, particularly Th1 skewing and inhibition of Th2 and Th17 cells, suggest it could enhance immune responses to tumors by promoting the generation of cytotoxic T cells and cytokines that inhibit cancer cell survival. Soquelitinib also aims to prevent T cell exhaustion, a significant limitation of current immunotherapy and CAR-T treatments. The drug’s ability to influence T cell differentiation and function holds promise for treating various cancers and autoimmune or allergic diseases.