Head-to-head trial of dostarlimab vs. pembrolizumab in lung cancer achieves key endpoint
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A head-to-head trial of the PD-1 inhibitors dostarlimab and pembrolizumab, each in combination with chemotherapy, met its primary endpoint of objective response rate among patients with metastatic nonsquamous non-small cell lung cancer.
Topline data from the randomized, phase 2 PERLA trial also showed dostarlimab (Jemperli, GSK) had a safety profile consistent with similar regimens in previous clinical trials, according to a GSK press release.
The company additionally announced that it is advancing both arms of the COSTAR Lung trial, which is comparing the safety and efficacy of the investigational selective anti-TIM-3 monoclonal antibody cobolimab plus dostarlimab and docetaxel and dostarlimab plus docetaxel vs. docetaxel alone among 750 patients with advanced NSCLC who experienced progression on previous anti-PD-L1 therapy and chemotherapy.
“These trials support the ambition for dostarlimab to become the backbone of our ongoing immuno-oncology-based research and development program when used alone and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options,” Hesham Abdullah, senior vice president and global head of oncology development for GSK, said in the press release.
The open-label, double-blind PERLA trial included 243 first-line patients with metastatic nonsquamous NSCLC and no known sensitizing epidermal growth factor receptor, anaplastic lymphoma kinase or receptor tyrosine kinase-1 mutation, BRAF V600E mutation, or other genomic mutation for which an approved targeted therapy is available, the press release stated. ORR of dostarlimab plus chemotherapy vs. pembrolizumab (Keytruda, Merck) plus chemotherapy, per blinded independent central review according to RECIST v1.1, served as the primary endpoint. Secondary endpoints include investigator-assessed PFS, OS and safety. The trial has not been designed to show superiority.
The most common treatment-emergent adverse events with dostarlimab include anemia, asthenia, nausea, constipation, cough, dyspnea, vomiting, decreased appetite and neutropenia.
Complete results of the PERLA trial will be presented at a future medical meeting, according to the press release.
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