First-Line Prolgolimab Plus Chemotherapy Improves Survival for Advanced Non-Squamous Non-Small Cell Lung Cancer
According to results from the phase 3 DOMAJOR study, first-line prolgolimab plus chemotherapy improved survival outcomes among patients with advanced non-squamous non-small cell lung cancer (NSCLC).
In this study, 292 patients were randomized on a 1-to-1 basis to receive 4 cycles of pemetrexed and a platinum-based drug plus either 3 mg/kg of prolgolimab once every 3 weeks or placebo, followed by maintenance prolgolimab or placebo and pemetrexed for up to 36 months or until disease progression or unacceptable toxicity. The primary end point was overall survival (OS). Key secondary end points included progression-free survival (PFS) and safety.
At a median follow-up of 18 months, the median OS was not reached in the prolgolimab arm and 14.6 months in the placebo arm (hazard ratio [HR], 0.51; 95% confidence interval [CI], 0.35 to 0.73; P = .0001). This OS benefit was observed independent of PD-L1 status. Median PFS was 7.7 months in the prolgolimab arm and 5.5 months in the placebo arm (HR, 0.65; 95% CI, 0.49 to 0.85; P = .0004). Adverse events occurring in ≥ 10% of patients in the prolgolimab arm most frequently included blood creatinine increase and dyspnea.
“Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns,” concluded Dr Laktionov et al. “This benefit was retained in patients with PD-L1 negative tumors.”
Source:
Laktionov K, Smolin A, Stroyakovski D, et al. Prolgolimab with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer. Eur J Cancer. Published online: January 21, 2025. doi: 10.1016/j.ejca.2025.115255
