In the global, open-label, phase 2/3 study KEYNOTE-010, pembro 10 mg/kg or 2 mg/kg Q3W improved OS vs docetaxel in pts with previously treated advanced NSCLC with PD-L1 TPS ≥50% and ≥1% (coprimary analyses) at median follow-up of 13.1 mo. We present long-term results overall, in pts who completed 35 cycles (∼2 y) of pembro, and in pts who received a second course of pembro.
Pts aged >18 y 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, until disease progression/intolerable toxicity. Response was assessed every 9 wk (RECIST 1.1 by independent central review), and survival every 2 mo posttreatment. There was no difference between pembro doses in the primary analysis, thus doses were pooled in this analysis.
As of March 16, 2018, median (range) follow-up was 42.6 (35.2–53.2) mo overall (N = 1033). Pembro improved OS vs docetaxel in pts with PD-L1 TPS ≥50% (HR, 0.53; 95% CI, 0.42–0.66; P < 0.00001) and TPS ≥1% (HR, 0.69; 95% CI, 0.60–0.80; P < 0.00001). In pts with PD-L1 TPS ≥50%, median (95% CI) OS was 16.9 (12.3–21.4) mo with pembro vs 8.2 (6.4–9.8) mo with docetaxel; 36-mo OS rates were 35% vs 13%, respectively. Similar to the primary analysis, 16% of pembro pts and 36% of docetaxel pts had grade 3–5 treatment-related AEs. 79 of 690 pembro pts received 35 treatment cycles (∼2 y). 36-mo OS rate among these 79 pts was 99% and 75 (95%) had PR/CR as best response; 72 pts (91%) remained alive. 48 pts (64%) had an ongoing response; median duration of response was not reached (range, 4–46+ mo). 25 of 79 pts (32%) had PD (investigator review) after stopping 35 cycles of pembro. 14 pts received second course pembro, 5 of whom completed 17 cycles; 6 (43%) had PR, 5 (36%) had SD, and 11 (79%) remained alive.
At 43-mo follow-up, 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 35 cycles (∼2 y) of pembro had durable response. The majority of pts with PD by investigator review who received second course pembro had either PR or SD and remained alive.
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.
NCT01905657.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
R.S. Herbst: Consulting role: Eli Lilly, Genentech/Roche, Merck, NextCure, Novartis, Pfizer; Research support: AstraZeneca, Eli Lilly, Merck. E.B. Garon: Funding to institution: Merck & Co., Inc., AstraZeneca, Eli Lilly, Genentech, Bristol-Myers Squibb, Pfizer, Novartis, Mirati. B. Chul Cho: Honoraria: AstraZeneca, Roche, Boehringer Ingelheim; Research funding: Bayer, AstraZeneca, Yuhan, Novartis; Consultant or advisor: AstraZeneca, Roche, Boehringer Ingelheim; Speakers’ bureau: AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis. J.L. Pérez Gracia: Grants: Merck Sharp & Dohme, Bristol-Myers Squibb, Roche, Lilly; Advisor, speakers’ bureau: Bristol-Myers Squibb, Roche. J-Y. Han: Honoraria: AstraZeneca, Roche, Bristol-Myers Squibb, Merck Sharp & Dohme; Research funding: Roche; Consultant or advisor: AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Eli Lilly. M. Majem: Consultant or advisor: AstraZeneca, Roche, Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis. M. Forster: Research grants: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp & Dohme, Merck; Honoraria for advisory and consultancy roles: Achilles, AstraZeneca, Bristol-Myers Squibb, Celgene, Eli Lilly, Merck, Merck Sharp & Dohme, Novartis, Pfizer, PharmaMar, Roche. I. Monnet: Congress invitations: Roche, AstraZeneca. S. Novello: Funding to institution: Merck Sharp & Dohme; Speakers bureau: Eli Lilly, Takeda, Roche, AstraZeneca, Merck Sharp & Dohme, Boehringer Ingelheim. M.A. Gubens: Research grant to institution: Merck & Co., Inc.; Personal fees for consulting: AbbVie, Ariad, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Calithera, Clovis, Genentech-Roche, Mersana, Nektar, Novartis, Pfizer. A. Samkari, E. Jensen, G.M. Lubiniecki: Employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. P. Baas: Consulting role: Genentech/Roche, Merck, Bristol-Myers Squibb, Pfizer; Research support: Bristol-Myers Squibb, Roche, Merck. All other authors have declared no conflicts of interest.