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2019 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Oral Abstract Session

Time: Sunday June 2, 9:45 AM to 12:45 PM

Location: Arie Crown Theater

Pembrolizumab with or without chemotherapy versus chemotherapy for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: The phase III KEYNOTE-062 study.

Esophageal or Gastric Cancer

Gastrointestinal (Noncolorectal) Cancer

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr LBA4007)

Author(s): Josep Tabernero, Eric Van Cutsem, Yung-Jue Bang, Charles S. Fuchs, Lucjan Wyrwicz, Keun Wook Lee, Iveta Kudaba, Marcelo Garrido, Hyun Cheol Chung, Hugo Raul Castro Salguero, Wasat Mansoor, Maria Ignez Freitas Melro Braghiroli, Eray Goekkurt, Joseph Chao, Zev A. Wainberg, Uma Kher, Sukrut Shah, SoonMo Peter Kang, Kohei Shitara; Vall d’Hebron University Hospital and Institute of Oncology, Barcelona, Spain; University Hospitals Gasthuisberg, Leuven and KU Leuven, Leuven, Belgium; Seoul National University College of Medicine, Seoul, Korea, Republic of (South); Yale Cancer Center, New Haven, CT; M. Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland; Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea; Riga East University Hospital, Riga, Latvia; Pontificia Universidad Católica de Chile, Santiago, Chile; Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea; Hospital de Enfermedad Comun Igss Zona 9, Guatemala, Guatemala; Christie NHS, Manchester, United Kingdom; Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, São Paulo, Brazil; Hematology Oncology Practice Eppendorf, and University Cancer Center Hamburg, Hamburg, Germany; City of Hope Comprehensive Cancer Center, Duarte, CA; David Geffen School of Medicine at UCLA, Los Angeles, CA; Merck & Co., Inc., Kenilworth, NJ; Merck & Co., Inc., Rahway, NJ; Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Abstract Disclosures


Background: KEYNOTE062 (NCT02494583) was a randomized, active controlled study of 1L P or P+C vs C in pts with PD-L1 combined positive score ≥1 (CPS ≥1), HER2-negative, advanced GC. Methods: Eligible pts were randomized 1:1:1 to P 200 mg Q3W for up to 2 y, P+C (cisplatin 80 mg/m2 + 5-FU 800 mg/m2/d on d1-d5 Q3W [or capecitabine 1000 mg/m2 BID on d1-d14 Q3W per local guideline]) or placebo Q3W + C. Randomization was stratified by region, disease status, and fluoropyrimidine treatment. Primary endpoints were OS in CPS ≥1 and CPS ≥10 for P+C vs C and P vs C and PFS (RECIST v1.1; central review) in CPS ≥1 for P+C vs C. ORR (RECIST v1.1; central review) in CPS ≥1 for P+C vs C was the secondary endpoint. Final analysis cutoff date was 26 Mar 2019. Results: 763 pts (281 with CPS ≥10) were randomized to P+C (257), P (256), or C (250) (Table). Median follow-up was 11.3 mo. P was noninferior to C for OS in CPS ≥1 per prespecified margins. P vs C prolonged OS in CPS ≥10 (median 17.4 vs 10.8 mo; HR 0.69; 95% CI 0.49-0.97) but wasn’t tested per analysis plan. P+C vs C was not superior for OS in CPS ≥1 or CPS ≥10, with a favorable trend for P+C. P+C did not significantly prolong PFS in CPS ≥1. ORR was higher for P+C vs C. Grade 3-5 drug-related AE rates were 17% (P), 73% (P+C), and 69% (C). Conclusions: As 1L therapy for advanced GC, P was noninferior to C for OS in CPS ≥1 with clinically meaningful improvement for OS in CPS ≥10. P+C did not show superior OS and PFS in CPS ≥1 and OS in CPS ≥10. The safety profile was more favorable for P vs C. Clinical trial information: NCT02494583

CPS ≥1
aMedian, mo (95% CI)
OSa12.5 (10.8-13.9)/ 11.1 (9.2-12.8)10.6 (7.7-13.8)/11.1 (9.2-12.8)
HR (95% CI)/ b99.2% CI0.85 (0.70, 1.03)
0.91 (0.74-1.10)
0.91b (0.69-1.18); NI margin = 1.2
PFSa6.9 (5.7-7.3)/ 6.4 (5.7-7.0)2.0 (1.5-2.8)/6.4 (5.7-7.0)
HR (95% CI)0.84 (0.70-1.02); P=0.0391.66 (1.37-2.01)
ORR, % (95% CI)48.6 (42.4-54.9)/36.8 (30.8-43.1)14.5 (10.4-19.4)/36.8 (30.8-43.1)
CPS ≥10N=99N=90N=92N=90
OSa12.3 (9.5-14.8)/10.8 (8.5-13.8)17.4 (9.1-23.1)/10.8 (8.5-13.8)
HR (95% CI)0.85 (0.62-1.17); P=0.1580.69 (0.49-0.97)
PFSa5.7 (5.5-8.2)/6.1 (5.3-6.9)2.9 (1.6-5.4)/6.1 (5.3-6.9)
ORR, % (95% CI)52.5 (42.2-62.7)/36.7 (26.8-47.5)25.0 (16.6-35.1)/36.7 (26.8-47.5)

Other Abstracts in this Sub-Category:


1. ARTIST 2: Interim results of a phase III trial involving adjuvant chemotherapy and/or chemoradiotherapy after D2-gastrectomy in stage II/III gastric cancer (GC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4001 First Author: Se Hoon Park
Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal or Gastric Cancer


2. Optimizing chemotherapy for frail and elderly patients (pts) with advanced gastroesophageal cancer (aGOAC): The GO2 phase III trial.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4006 First Author: Peter S Hall
Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal or Gastric Cancer


3. Efficacy and safety of pembrolizumab (pembro) alone or in combination with chemotherapy (chemo) in patients (pts) with advanced gastric or gastroesophageal (G/GEJ) cancer: Long-term follow up from KEYNOTE-059.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4009 First Author: Zev A. Wainberg
Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal or Gastric Cancer