- 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.
- 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.
- 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.
- No long-term follow-up.