Phase 3 trial of durvalumab for advanced NSCLC misses primary endpoints
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A randomized phase 3 trial that evaluated durvalumab vs. chemotherapy for treatment of certain patients with stage IV non-small cell lung cancer failed to meet its primary endpoint of OS, according to the agent’s manufacturer.
Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1.
The open-label, multicenter PEARL trial evaluated durvalumab monotherapy vs. investigator’s choice of platinum-based chemotherapy as first-line treatment for patients with metastatic NSCLC.
Eligible patients had tumors that expressed PD-L1 on at least 25% of tumor cells.
The study population — comprised primarily of Asian individuals — included smokers and nonsmokers, as well as patients with squamous or nonsquamous histology. Investigators excluded patients with certain EGFR mutations or anaplastic lymphoma kinase fusions.
OS among all patients whose tumors expressed PD-L1 on at least 25% of tumor cells, as well as among a subgroup of patients identified as being at low risk for early mortality, served as primary endpoints. Researchers reported no significant OS benefit in either group.
The trial — conducted in Asia, Europe and Australia — met a secondary endpoint, with results showing improved OS with durvalumab among a subgroup of patients with PD-L1 expression on at least 50% of tumor cells.
Durvalumab exhibited a safety profile consistent with prior reports. Researchers observed no new safety signals.
“With PEARL, we set out to answer important scientific questions in the treatment of metastatic non-small cell lung cancer at a time when patient selection for immune checkpoint inhibitors was still evolving,” Susan Galbraith, MBBChir, PhD, MRCP, FRCR, FMedSci, executive vice president for oncology research and development with AstraZeneca, said in a company-issued press release. “We are encouraged to see patients in the metastatic setting at a higher level of PD-L1 tumor expression demonstrate the most benefit with Imfinzi monotherapy treatment, as is commonly seen in this class.”
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