KEYNOTE-010 (NCT01905657) is a global, open-label, phase 2/3 study of pembro 10 mg/kg or 2 mg/kg Q3W vs docetaxel in pts with previously treated advanced NSCLC with PD-L1 TPS ≥1%. Pembro improved OS vs docetaxel in the PD-L1 TPS ≥1% and ≥50% co-primary analyses (median follow-up, 13.1 mo), with no difference between pembro doses. We present updated OS for the study overall and results for pts who completed 35 cycles (~2 y) of pembro.
Pts >18 years with previously treated advanced NSCLC with PD-L1 TPS ≥1% were randomized (1:1:1) to pembro 10 mg/kg or 2 mg/kg Q3W, or docetaxel 75 mg/m2 Q3W. Pts received pembro for 35 cycles or until disease progression/intolerable toxicity. After the primary analysis, crossover from docetaxel to pembro was allowed. Response was assessed every 9 wk (RECIST 1.1 by independent central review), and survival every 2 mo after treatment ended. OS was a primary endpoint. Pembro doses were pooled.
As of March 16, 2018, median (range) follow-up was 42.5 (35.2–53.2) mo. Among all pts (N=1033), pembro improved OS vs docetaxel (HR, 0.69; 95% CI, 0.60–0.80; P<0.00001), with median (95% CI) OS of 11.8 (10.4–13.1) mo vs 8.4 (7.6–9.5) mo, and 36-mo OS rate of 23% vs 11%, respectively. Incidence of grade 3–5 treatment-related AEs was similar to the primary analysis: 16% of pts in the pembro group and 36% in the docetaxel group had grade 3–5 treatment-related AEs (0.7% and 1.6%, respectively, had grade 5 AEs). 22% and 9% of pts, respectively, had immune-mediated AEs and infusion reactions. Among 79 pts who completed 35 pembro cycles, the 36-mo OS rate was 99% and 95% had PR/CR as best response. Response was ongoing in 44 pts (59%); median duration of response was not reached (range, 1+ to 46+ mo). 25 of 79 pts (32%) had PD (investigator review) after stopping 35 cycles of treatment, 13 of whom started second course pembro.
With an additional 30-mo follow-up from the primary analyses, pembro continued to prolong OS vs docetaxel in pts with previously treated, PD-L1–expressing advanced NSCLC, with manageable long-term safety. Most pts who completed 2 y of pembro had durable response, and the majority of pts who had PD after stopping 35 cycles of pembro were able to receive a second course of pembro.
Clinical trial identification
Medical writing and editorial assistance was provided by C4 MedSolutions, LLC (Yardley, PA), a CHC Group company. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.