Phase II trial of Jemperli (dostarlimab) plus chemotherapy in patients with metastatic non-squamous non-small cell lung cancer shows positive headline results: GSK

Full results from the PERLA phase II trial, including the primary endpoint of ORR and the key secondary endpoint of progression-free survival, with results by programmed death ligand-1 (PD-L1) expression subgroups, will be presented at an upcoming scientific meeting.

The safety and tolerability profile of dostarlimab in the PERLA phase II trial was consistent with previous clinical trials of similar regimens.

In addition, GSK is also advancing both arms of the COSTAR Lung trial into phase III. The decision follows the recommendation of the Independent Data Monitoring Committee, given that the trial met its pre-specified expansion criteria per protocol. The COSTAR Lung phase III trial is a randomized, open label 3-arm trial comparing cobolimab, an investigational selective anti–TIM-3 monoclonal antibody, plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: "These trials support the ambition for dostarlimab to become the backbone of our ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options."