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Found 2 Presentations For Request "LBA8_PR"
LBA8_PR - Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study
- Ken Kato (Chuo-ku, Japan)
Abstract
Background
KEYNOTE-590 (NCT03189719) is a randomized, international, double-blind study of 1L pembrolizumab (pembro) + chemotherapy (chemo) vs chemo alone in patients (pts) with locally advanced/unresectable or metastatic adenocarcinoma or esophageal squamous cell carcinoma (ESCC) or Siewert type 1 esophagogastric junction adenocarcinoma (EGJ).
Methods
Eligible pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2 yr + chemo (cisplatin 80 mg/m2 Q3W [d1; 6 doses] + 5-FU 800 mg/m2 on d1-5 Q3W). Randomization was stratified by Asia vs Rest of World, adenocarcinoma vs ESCC, and ECOG PS 0 vs 1. Treatment continued until progression, unacceptable toxicity, or withdrawal, or 2 yr. No crossover was permitted. Primary end points were OS in pts with ESCC PD-L1 combined positive score (CPS) ≥10 tumors, and OS and PFS (RECIST v1.1 ; by investigator) in ESCC, PD-L1 CPS ≥10, and all pts. The secondary end point was ORR (RECIST v1.1; by investigator) in all pts. Data cutoff for interim OS/final PFS analysis was July 2, 2020.
Results
At data cutoff, 749 pts (83% male, 73% ESCC) were randomized (373 pembro + chemo; 376 chemo). Median follow-up was 10.8 mo. Pembro + chemo vs chemo was superior for OS in pts with ESCC CPS ≥10 (median 13.9 vs 8.8 mo; HR 0.57; 95% CI, 0.43-0.75;
Conclusions
Pembro + chemo provided superior OS, PFS, and ORR vs chemo, with a manageable safety profile in pts with untreated, advanced esophageal and EGJ cancer. These data demonstrate that 1L pembro + chemo is a new standard of care in this pt population.
Clinical trial identification
NCT03189719.
Editorial acknowledgement
Luana Atherly-Henderson of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Legal entity responsible for the study
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Funding
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
K. Kato: Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Ono; Advisory/Consultancy, Research grant/Funding (institution): Beigene; Speaker Bureau/Expert testimony: Taiho; Speaker Bureau/Expert testimony: Eli Lilly; Research grant/Funding (institution): Shionogi; Research grant/Funding (institution): Merck Bio; Research grant/Funding (institution): Chugai. J-M. Sun: Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Ono; Research grant/Funding (institution): MSD. M.A. Shah: Advisory/Consultancy: Daiichi; Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp & Dohme Corp.; Research grant/Funding (institution): Boston Biomedical; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Oncolys. P.C. Enzinger: Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Celgene; Honoraria (self), Advisory/Consultancy: Daiichi-Sankyo; Honoraria (self), Advisory/Consultancy: Five-Prime; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Loxo; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme Corp.; Honoraria (self), Advisory/Consultancy: Taiho; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy: Zymeworks. A. Adenis: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Research grant/Funding (institution): Sanofi; Advisory/Consultancy: Servier; Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck Sharp & Dohme Corp.; Research grant/Funding (institution): Pfizer. T. Doi: Honoraria (self), Research grant/Funding (institution): Bristol Myers Squibb; Honoraria (self): Ono Pharmaceutical; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Abbvie; Honoraria (self): Astellas Pharma; Honoraria (self): Oncolys BioPharma; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Taiho Pharmaceutical; Honoraria (self): Otsuka; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Daiichi Sankyo; Advisory/Consultancy: Amgen; Advisory/Consultancy, Research grant/Funding (institution): Sumitomo Dainippon; Advisory/Consultancy: Takeda; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: Bayer; Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim; Advisory/Consultancy: Rakuten Medical; Research grant/Funding (institution): Merck Serono; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Kyowa Hakko Kirin; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): IQVIA. T. Kojima: Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self): Oncolys BioPharma; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Ono Pharmaceutical; Advisory/Consultancy: Merck; Research grant/Funding (institution): Astellas Amgen BioPharma; Research grant/Funding (institution): Taiho Pharmaceutical; Research grant/Funding (institution): Shionogi. J-P. Metges: Honoraria (self): MSD; Honoraria (self): Bayer; Honoraria (self): Bristol Myers Squibb. S-B. Kim: Advisory/Consultancy, Research grant/Funding (self): Novartis; Research grant/Funding (self): Sanofi-Aventis; Research grant/Funding (self): DongKook Pharma Co.; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Lilly; Advisory/Consultancy: Enzychem; Advisory/Consultancy: Dae Hwa Pharmaceutical Co. Ltd; Advisory/Consultancy: ISU Abxis; Advisory/Consultancy: Daiichi-Sankyo. B.C. Chul Cho: Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Roche; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Ono; Advisory/Consultancy, Research grant/Funding (institution): Yuhan; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution): Janssen; Advisory/Consultancy: Medpacto; Advisory/Consultancy, Research grant/Funding (institution): Blueprint Medicines; Advisory/Consultancy, Shareholder/Stockholder/Stock options: KANAPH Therapeutic Inc.; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Brigebio Therapeutics; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Cyrus Therapeutics; Advisory/Consultancy: Guardant Health; Shareholder/Stockholder/Stock options: TheraCanVac Inc; Shareholder/Stockholder/Stock options, Officer/Board of Directors: Gencurix Inc; Research grant/Funding (institution), Shareholder/Stockholder/Stock options, Officer/Board of Directors: Interpark Bio Convergence Corp.; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): MOGAM Institute; Research grant/Funding (institution): Dong-A ST; Research grant/Funding (institution), Licensing/Royalties: Champions Oncology; Research grant/Funding (institution): Dizal Pharma; Advisory/Consultancy, Research grant/Funding (institution): MSD; Research grant/Funding (institution): Abbvie; Research grant/Funding (institution): Medpacto; Research grant/Funding (institution): GIInnovation; Leadership role, founder: DAAN Biotherapeutics; Advisory/Consultancy: Takeda. S-H. Li: Research grant/Funding (institution): MSD. M.A. Maqueda: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: Amgen. E. Goekkurt: Honoraria (self): MSD; Honoraria (self): Bristol Myers Squibb; Honoraria (self): Servier. Q. Liu: Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. S. Shah: Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. P. Bhagia: Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. L. Shen: Advisory/Consultancy: Merck Sharp & Dohme Corp.; Advisory/Consultancy: Harbour; Research grant/Funding (self): Boehringer Ingelheim; Research grant/Funding (self): Beijing Xiantong Biomedical Technology; Research grant/Funding (self): Qilu Pharmaceutical; Research grant/Funding (self): Zaiding Pharmaceutical; Research grant/Funding (self): Jacobio Pharmaceuticals; Research grant/Funding (self): Beihai Kangcheng(Beijing)Medical Technology Co., Ltd. All other authors have declared no conflicts of interest.
Invited Discussant LBA8_PR and LBA9_PR
- Andres Cervantes (Valencia, Valencia, Spain)