Phase II trial of Jemperli (dostarlimab) plus chemotherapy in patients with metastatic non-squamous non-small cell lung cancer shows positive headline results: GSK
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.
UK: GSK plc has announced positive headline results of the PERLA phase II trial, which met its primary endpoint of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumours (RECIST) criteria as determined by blinded independent central review.
The trial evaluated dostarlimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy in first-line patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
"The PERLA phase II trial is a randomised, double-blind trial of 243 patients and is the largest global head-to-head trial of programmed death receptor-1 (PD-1) inhibitors in this population.The trial was not designed to demonstrate superiority," the company stated.
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."
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