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STATISTICALLY SIGNIFICANT IMPROVEMENT
IN OVERALL SURVIVAL12
The most common adverse events (incidence ≥15%) in the KEYNOTE-407 study were anemia, alopecia, neutropenia, nausea, thrombocytopenia, diarrhea, decreased appetite, constipation, fatigue, asthenia, arthralgia, peripheral neuropathy, vomiting, cough, and dyspnea.
Median OS was 15.9 months (95% CI: 13.2, NE) in the pembrolizumab combination group vs 11.3 months (95% CI: 9.5-14.8) in the placebo combination group (HR: 0.64 [95% CI: 0.49-0.85]*; P=0.0017†)
Median progression-free survival (coprimary endpoint)6.4 months (95% CI: 6.2-8.3) in the pembrolizumab combination group vs 4.8 months (95% CI: 4.3-5.7) in the placebo combination group (HR: 0.56; 95% CI: 0.45-0.70; P<0.0001).
- *Based on the stratified Cox proportional hazard model.
- †Based on stratified log-rank test.
- NE=not estimable.
- See the Subgroup Analysis by Taxane
OVERALL SURVIVAL SUBGROUP ANALYSIS BY TAXANE-BASED DRUG (EXPLORATORY ANALYSIS)11
FROM THE NEW ENGLAND JOURNAL OF MEDICINEData cutoff April 3, 2018
(95% CI: 0.36-0.98; n=events/patients, 65/223)
(95% CI: 0.48-0.93; n=events/patients, 140/336)
Treatment effect was observed with pembrolizumab and chemotherapy in prespecified stratification factors: region of enrollment, PD-L1 TPS, and taxane-based drug.