Phase III Study of Niraparib Plus Pembrolizumab as Maintenance Therapy for Advanced or Metastatic NSCLC (ZEAL-1L).
Suresh S Ramalingam, Vamsidhar Velcheti, Mehmet Altan et al.
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In 30 seconds
ZEAL-1L was a randomized, double-blind, multicentre phase III trial of maintenance niraparib plus pembrolizumab versus placebo plus pembrolizumab in adults with advanced or metastatic squamous or nonsquamous NSCLC without a known targetable driver alteration. Among patients whose disease had a complete or partial response to first-line chemotherapy plus pembrolizumab, median progression-free survival was 5.55 months in both arms (hazard ratio, 1.00; 95% confidence interval: 0.79-1.27; 1-sided p = 0.502). The investigators concluded that adding niraparib did not improve efficacy; no new safety signals were detected.
Key findings
- In the CR/PR population, median PFS was 5.55 months in both arms (hazard ratio, 1.00; 95% confidence interval: 0.79-1.27; 1-sided p = 0.502).
- Key secondary outcomes, including PFS in the ITT population and overall survival, were not formally tested after the primary end point did not reach statistical significance.
- The most common grade 3 or higher treatment-related adverse events with niraparib plus pembrolizumab were anemia, thrombocytopenia, and neutropenia.
Why it matters
The trial found no progression-free survival advantage from adding niraparib to pembrolizumab maintenance in the prespecified response subgroup. This provides direct comparative evidence against an efficacy benefit for this combination in the studied population, while the untested secondary outcomes limit conclusions about broader survival effects.
What to keep in mind
Because the primary end point did not reach statistical significance, hierarchical testing stopped and key secondary outcomes were not formally tested.