pembrolizumab plus SoC (n=228) vs. placebo plus SoC (n=225)
randomized controlled trial
pembrolizumab plus etoposide plus platine
pembrolizumab (200 mg fixed dose on Day 1 of each 21-day cycle) in combination with etoposide (100 mg/m2 on Days 1, 2 and 3) and investigator's choice of platinum chemotherapy (carboplatin titrated to AUC 5 on Day 1 or cisplatin 75 mg/m2 on Day 1)
placebo plus etoposide plus platine
Placebo in combination with etoposide (100 mg/m2 on Days 1, 2 and 3) and investigator's choice of platinum chemotherapy (carboplatin titrated to AUC 5 mg/mL/min on Day 1 or cisplatin 75 mg/m2 on Day 1).
Extensive stage SCLC (Es-SCLC) - 1st Line (L1)
double-blind
133 sites in 18 countries
P3/ one sided and two interim analysis. the study had 96% power to demonstrate a PFS HR of 0.65 at a = .006 with 387 PFS events at thefinal PFS analysis and 94%power to demonstrate an OS HRof 0.65 at a = .019 with 294 deaths at the final OS analysis. Then ORR can be tested with 0.001a reallocated from each PE.
Pembro plus etoposide/platine significantly improved PFS compared with placebo plus etoposide/platine as first-line therapy for patients with ES-SCLC but OS did not meet its significance treshold.