Glaxo Smith Kline headquarters, London

William Barton

GSK (NYSE:GSK) said its medicine Jemperli (dostarlimab) met the main goal of showing objective response rate (ORR) in certain patients with non-small cell lung cancer (NSCLC) in a phase 2 trial.

The study, dubbed PERLA, evaluated Jemperli in combination with chemotherapy versus Merck’s (NYSE:MRK) Keytruda (pembrolizumab) in combination with chemotherapy in first-line patients with metastatic NSCLC, the company noted in an Oct. 5 press release.

The British pharma giant said that the PERLA study, which included 243 patients, was not designed to show superiority and is the largest global head-to-head trial of programmed death receptor-1 (PD-1) inhibitors in this population.

Jemperli is currently approved in the U.S. to treat adults with recurrent or advanced endometrial cancer in a second-line setting.

GSK added that the safety and tolerability profile of Jemperli in the PERLA study was consistent with previous trials of similar regimens. The most common treatment-emergent adverse reactions were anemia, asthenia (weakness), nausea, constipation, cough, dyspnoea (breathing difficulty), vomiting, decreased appetite, and neutropenia (low levels of a type of white blood cell called neutrophils).

Full results from the study, including the main goal of ORR and the key secondary goal of progression-free survival, with results by programmed death ligand-1 (PD-L1) expression subgroups, will be presented at an upcoming scientific meeting, GSK added.

In addition, GSK said that was also advancing both arms of a study called COSTAR Lung into phase 3 after the recommendation of the data monitoring committee, as the trial met its expansion criteria per protocol.

The COSTAR Lung phase 3 trial is a 3-arm trial comparing cobolimab plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-L1 therapy and chemotherapy.

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