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NSCLC, metastatic

3947 - Pembrolizumab (pembro) vs docetaxel (doce) for previously treated, PD-L1–expressing NSCLC: Updated outcomes of KEYNOTE-010


09 Oct 2016


NSCLC, metastatic


Roy S. Herbst


Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435


R.S. Herbst1, P. Baas2, D. Kim3, E. Felip4, J.L. Pérez-Gracia5, J. Han6, J. Molina7, J. Kim8, C. Dubos Arvis9, M.A. Ahn10, M. Majem11, M.J. Fidler12, G. De Castro Jr.13, M. Garrido14, Y. Shentu15, G.M. Lubiniecki16, E.B. Garon17

Author affiliations

  • 1 Medical Oncology, Yale Cancer Center, Smilow Cancer Hospital, Yale School of Medicine, 06520-8032 - New Haven/US
  • 2 Thoracic Oncology, The Netherlands Cancer Institute, 1066CX - Amsterdam/NL
  • 3 Internal Medicine, Seoul National University Hospital, 03080 - Seoul/KR
  • 4 Oncologia Médica, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 5 Oncology, Clinica Universidad de Navarra, Pamplona/ES
  • 6 Center For Lung Cancer, National Cancer Center, Goyang/KR
  • 7 Oncology, Mayo Clinic, Rochester/US
  • 8 Department Of Oncology, CHA Bundang Medical Center, CHA University, Gyeonggi-do/KP
  • 9 Department Of Oncology, Centre Francois Baclesse, Caen/FR
  • 10 Division Of Hematology-oncology, Department Of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul/KR
  • 11 Medical Oncology, Hospital de la Santa Creu i Sant Pau, 08026 - Barcelona/ES
  • 12 Internal Medicine, Rush University Medical Center, Chicago/US
  • 13 Oncologia Clínica, ICESP - Instituto do Câncer do Estado de São Paulo, 01246-000 - Sao Paulo/BR
  • 14 Hematology And Medical Oncology, Pontificia Universidad Catolica de Chile-Cancer centre, Santiago/CL
  • 15 Bards, Merck & Co., Inc., Kenilworth/US
  • 16 Oncology Clinical Development, Merck & Co., Inc., Kenilworth/US
  • 17 Medicine, Division Of Hematology/oncology, David Geffen School of Medicine at UCLA, Los Angeles/US


Abstract 3947


In KEYNOTE-010 (NCT01905657), pembro provided superior OS over doce in patients (pts) with previously treated advanced NSCLC for the co-primary PD-L1 tumor proportion score (TPS) ≥1% and ≥50% populations, with no difference between pembro doses. To better characterize long-term outcomes in KEYNOTE-010, an analysis based on an additional 6 mo of follow-up was performed.


1034 pts with NSCLC of TPS ≥1% that progressed on ≥2 doses of platinum-doublet chemotherapy were randomized to pembro 2 or 10 mg/kg Q3W or doce 75 mg/m2 Q3W. Crossover upon progression was not permitted until Dec 2015. Response was assessed every 9 wk per RECIST v1.1 by central review. Survival was assessed every 2 mo after study treatment discontinuation. Differences in OS were assessed in the ITT population using the stratified log-rank test.


As of Mar 31, 2016, median follow-up was 19.2 mo and median (range) exposure was 106 d (1-773) for pembro 2 mg/kg, 106 d (1-742) for pembro 10 mg/kg, and 62 d (1-462) for doce. Pembro continued to show superior OS with no difference between doses (Table). 18-mo OS rates were 37% with pembro 2 mg/kg, 43% with pembro 10 mg/kg, and 24% with doce for TPS ≥1% and 46%, 52%, and 24% for TPS ≥50%. ORR was higher with pembro for TPS ≥1% (19% vs 20% vs 10%) and ≥50% (29% vs 32% vs 9%). 60% of pembro and 15% of doce responders, including 65% and 15% with TPS ≥50%, were alive, progression free, and without new anticancer therapy. Treatment-related AE rates remained lower with pembro: 64% vs 67% vs 81% any grade, 13% vs 17% vs 36% grade 3-5.


Superior OS for pembro over doce in pts with previously treated, PD-L1–expressing advanced NSCLC was confirmed with longer follow-up, as was the lack of difference between pembro doses, durability of pembro responses, and, despite longer exposure, a lower rate of treatment-related AEs with pembro. These data support pembro as a standard of care for previously treated, PD-L1–expressing NSCLC.

Clinical trial identification

ClinicalTrials.gov number NCT01905657, originally posted July 18, 2013; EudraCT number 2012-004391-19, originally issued 16-Nov-2012

Pembro 2 mg/kg Pembro 10 mg/kg Doce
TPS ≥1%
Median (95% CI), mo 10.5 (9.6-12.4) 13.6 (11.4-17.3) 8.6 (7.9-9.8)
HR (95% CI)a 0.72 (0.60-0.87) 0.60 (0.50-0.73)
HR (95% CI)b 1.19 (0.98-1.45)
TPS ≥50%
Median (95% CI), mo 15.8 (11.0-26.0) 18.8 (12.3-NR) 8.2 (6.6-10.4)
HR (95% CI)a 0.54 (0.39-0.73) 0.48 (0.35-0.66)
HR (95% CI)b 1.18 (0.84-1.64)

aPembro vs doce. bPembro 2 mg/kg vs 10 mg/kg.

Legal entity responsible for the study

Merck & Co., Inc.


Merck & Co., Inc.


R.S. Herbst: Served as advisory board member for Merck and has received travel expenses, including accommodations, from Merck. P. Baas: Advisory board member: Merck, BMS, Verastem, Celgene; Research funding and travel expenses: Merck, BMS. E. Felip: Consultant/advisor with honoraria: Boehringer Ingelheim, MSD, Eli Lilly, Roche, Pfizer, Novartis, BMS, Celgene; Speakers' bureau: BMS, Novartis, Roche. J.L. Pérez-Gracia: Speakers' bureau and research funding: Merck. J-H. Kim: Reasearch funding: Roche, Lilly, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck. C. Dubos Arvis: Travel expenses: Novartis, Boehringer. M-J.A. Ahn: Advisory board member: BMS, Ono, MSD, Boehringer Ingelheim, AstraZeneca, Roche G. De Castro Jr.: Advisory board member: MSD, Roche, AstraZeneca; Speakers' bureau: MSD, Roche, AstraZeneca, BMS; Travel expenses: MSD. Y. Shentu, G.M. Lubiniecki: Employment and stock options: Merck & Co., Inc. E.B. Garon: Research funding: AstraZeneca, Boehringer-Ingelheim, BMS, Eli Lilly, Genentech, Merck, Novartis, Pfizer. All other authors have declared no conflicts of interest.

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