The mid-stage trial is a randomised, double-blind study featuring 243 patients with metastatic non-squamous NSCLC who met certain conditions
GSK has announced that phase 2 trial of dostarlimab plus chemotherapy in NSCLC patients has met its primary endpoint of ORR. (Credit: GSK plc.)
GSK has announced that the PERLA phase 2 trial of Jemperli (dostarlimab) plus chemotherapy in first-line, metastatic, non-squamous non-small cell lung cancer (NSCLC) patients has met its primary endpoint of objective response rate (ORR).
The mid-stage trial is a randomised, double-blind study involving 243 patients having metastatic non-squamous NSCLC who met certain conditions.
Dostarlimab plus chemotherapy was evaluated against Merck’s Keytruda (pembrolizumab) in combination with chemotherapy.
GSK said that the study was not intended to prove the superiority.
Dostarlimab’s safety and tolerability profile in the PERLA phase 2 trial was in line with that of earlier clinical studies using comparable regimens.
According to GSK, the ORR by Response Evaluation Criteria in Solid Tumours (RECIST) criteria was determined by blinded independent central review.
The progression-free survival (PFS) is the key secondary endpoint of the trial.
GSK said that it will present the full results from the PERLA phase 2 clinical trial, including ORR and PFS, with results by programmed death ligand-1 (PD-L1) expression subgroups, at an upcoming scientific meeting.
Separately, the firm is also advancing the two arms of the COSTAR Lung trial into phase 3.
The COSTAR Lung phase 3 trial is a randomised, open label three-arm study that will compare an investigational selective anti–TIM-3 monoclonal antibody called cobolimab plus dostarlimab and docetaxel versus dostarlimab plus docetaxel versus docetaxel alone in advanced NSCLC patients.
GSK oncology global head and SVP Hesham Abdullah 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.”