Corvus Pharmaceuticals released additional data from its Phase 1/1b clinical trial of soquelitinib, an oral ITK inhibitor, for T-cell lymphoma (TCL). The data, presented at the 16th Annual T-Cell Lymphoma Forum, showed promising anti-tumor activity and a reduction in T-cell exhaustion. Based on these positive results, Corvus is currently enrolling patients in a registrational Phase 3 trial.
This news is important because it offers potential advancements in TCL treatment. Current standard therapies like belinostat and pralatrexate have limited effectiveness, particularly in relapsed patients, who face a median progression-free survival of only 3 to 4 months. Soquelitinib’s observed 30% progression-free survival rate at 18 months, if confirmed in larger trials, could represent a substantial improvement in outcomes for these patients. The reduction in T-cell exhaustion observed in the study also suggests a novel mechanism of action that could further enhance anti-tumor immunity.
The Phase 1/1b trial of soquelitinib enrolled 25 patients at the optimal dose of 200 mg twice daily. Of the 23 evaluable patients, 39% experienced objective responses (complete or partial), with a median duration of response of 17.2 months. Importantly, three patients remain on therapy at 14+ months, 18+ months, and 25+ months. The drug was well-tolerated without new safety signals, dose reductions, or treatment interruptions. The Phase 3 trial will compare soquelitinib against physician’s choice of either belinostat or pralatrexate in 150 patients with relapsed peripheral T-cell lymphoma (PTCL), aiming to confirm the efficacy and safety profile observed in earlier trials.
The positive data from the Phase 1/1b trial strengthens the potential of soquelitinib as a viable treatment option for relapsed PTCL. The ongoing Phase 3 trial is a crucial step toward potential regulatory approval and, if successful, could significantly alter the treatment landscape for this aggressive and often fatal form of cancer. This development underscores the potential of ITK inhibition as a novel approach to cancer immunotherapy, paving the way for further research and development in this area.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
