Addition of Olaparib to Pembrolizumab Maintenance Does Not Significantly Improve Survival for Patients With Metastatic Squamous Non-Small Cell Lung Cancer
According to results from a phase 3 study, the addition of olaparib to pembrolizumab in the maintenance setting did not significantly improve survival outcomes compared to pembrolizumab and placebo among patients with metastatic squamous non-small cell lung cancer (NSCLC).
In this double-blind study, researchers enrolled 851 patients with previously untreated stage IV squamous NSCLC to receive 200 mg of pembrolizumab (every 3 weeks) plus carboplatin and paclitaxel or nab-paclitaxel in 4 cycles as induction therapy. Patients who experienced disease control were randomized to receive 200 mg of pembrolizumab every 3 weeks plus either 300 mg of twice daily olaparib (n = 296) or placebo (n = 295) in 31 cycles. The primary end points included progression-free survival (PFS) and overall survival (OS). A key secondary end point was safety.
At a median follow-up of 27.1 months, median PFS was 8.3 months in the olaparib arm and 5.4 months in the placebo arm (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.63 to 0.93; P = .0040). At a median follow-up of 33.4 months, median OS was 19.1 months in the olaparib arm and 18.6 months in the placebo arm (HR, 1.01; 95% CI, 0.83 to 1.24; P = .5481). Treatment-related adverse events occurred in 76.5% and 65.1% of patients, respectively.
“Adding olaparib to pembrolizumab as maintenance therapy for metastatic squamous NSCLC did not significantly improve PFS versus pembrolizumab plus placebo [as] neither PFS nor OS met the prespecified statistical significance boundary,” concluded study authors.
Source:
Hochmair M, Schenker M, Dols MC, et al. Pembrolizumab with or without maintenance olaparib for metastatic squamous non-small cell lung cancer that responded to first-line pembrolizumab plus chemotherapy. J Thorac Oncol. Published online: October 28, 2024. doi: 10.1016/j.jtho.2024.10.012