Sintilimab plus combination therapy yields good results in advanced NSCLC

  • J Thorac Oncol

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Chinese patients with stage IIIB to IV nonsquamous NSCLC treated with first-line sintilimab in combination with pemetrexed and platinum chemotherapy had significantly better PFS and objective response rate (ORR) than those who received combination therapy with a placebo.

Why this matters

  • Data are limited that address potential ancestry- or ethnicity-based differences in safety profiles for immunotherapy.

Study design

  • Randomized, double-blind, phase 3 study.
  • 397 patients with stage IIIB to IV nonsquamous NSCLC received sintilimab (n=266) or placebo (n=131) in combination with pemetrexed and platinum chemotherapy.
  • Funding: Innovent Biologics, Inc.; Eli Lilly and Company.

Key results

  • Median PFS was significantly longer with sintilimab vs placebo:
    • 8.9 vs 5.0 months.
    • HR, 0.482 (P<.00001>
  • ORR was significantly better with sintilimab vs placebo:
    • 51.9 % vs 29.8% (P=.00003).
  • A PFS and ORR benefit with sintilimab was found regardless of programmed death ligand 1 tumor proportion score.
  • Median OS was not reached but showed a trend toward better OS with sintilimab (HR, 0.609; 95% CI, 0.400-0.926).
  • Incidence of grade 3 or worse adverse events was 61.7% with sintilimab and 58.8% with placebo.

Limitations

  • No long-term follow-up.