{"id":26385,"date":"2020-09-21T16:30:00","date_gmt":"2020-09-21T16:30:00","guid":{"rendered":"http:\/\/0e76e6822c3828f41a9979262eea80bf"},"modified":"2024-11-03T15:16:18","modified_gmt":"2024-11-03T15:16:18","slug":"immunotherapy-is-beneficial-in-gastric-and-oesophageal-cancers-studies-show-esmo2020-press-release","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/immunotherapy-is-beneficial-in-gastric-and-oesophageal-cancers-studies-show-esmo2020-press-release\/","title":{"rendered":"Immunotherapy is Beneficial in Gastric and Oesophageal Cancers, Studies Show [ESMO2020 Press Release]"},"content":{"rendered":"

LBA8_PR – Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study<\/p>\n

\n

K. Kato1<\/sup>, J-M. Sun2<\/sup>, M.A. Shah3<\/sup>, P.C. Enzinger4<\/sup>, A. Adenis5<\/sup>, T. Doi6<\/sup>, T. Kojima7<\/sup>, J-P. Metges8<\/sup>, Z. Li9<\/sup>, S-B. Kim10<\/sup>, B.C. Chul Cho11<\/sup>, W. Mansoor12<\/sup>, S-H. Li13<\/sup>, P. Sunpaweravong14<\/sup>, M.A. Maqueda15<\/sup>, E. Goekkurt16<\/sup>, Q. Liu17<\/sup>, S. Shah17<\/sup>, P. Bhagia17<\/sup>, L. Shen18<\/sup>
1<\/sup>Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan, 2<\/sup>Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea, Republic of, 3<\/sup>Medical Oncology\/Solid Tumor Program, Weill Cornell Medical College, New York, NY, USA, 4<\/sup>Medical Oncology, Dana Farber Cancer Institute, Boston, MA, USA, 5<\/sup>Medical Oncology, IRCM, Inserm, Universit\u00e9 Montpellier, ICM, Montpellier, CEDEX, France, 6<\/sup>Experimental Therapeutics, National Cancer Center Hospital East, Chiba, Chiba, Japan, 7<\/sup>Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan, 8<\/sup>Cancer Institute, CHU Brest \u2013 Institut de Cancerologie et d\u2019Hematologie, Brest, Cedex 2, France, 9<\/sup>Thoracic & Esophageal Surgery, Shanghai Chest Hospital, Esophageal Disease Center,, Shanghai, China, 10<\/sup>Oncology, Asan Medical Center, Seoul, Korea, Republic of, 11<\/sup>Yonsei Cancer Center, Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of, 12<\/sup>Medical Oncology, Christie Hospital NHS Trust, Manchester, UK, 13<\/sup>Oncology and Hematology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, 14<\/sup>Medicine, Prince of Songkla University Hospital, Songkhla, Thailand, 15<\/sup>Medical Oncology, Vall d\u2019Hebron Institute of Oncology, Barcelona, Spain, 16<\/sup>Hematology-Oncology, Hematology Oncology Practice Eppendorf, and University Cancer Center Hamburg, Hamburg, Germany, 17<\/sup>Medical Oncology, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, 18<\/sup>Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China<\/p>\n

Background: <\/strong>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).<\/p>\n

Methods: <\/strong>Eligible pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2 yr + chemo (cisplatin 80 mg\/m2<\/sup> Q3W [d1; 6 doses] + 5-FU 800 mg\/m2<\/sup> 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) \u226510 tumors, and OS and PFS (RECIST v1.1 ; by investigator) in ESCC, PD-L1 CPS \u226510, 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.<\/p>\n

Results: <\/strong>At data cutoff, <\/strong>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 \u226510 (median 13.9 vs 8.8 mo; HR 0.57; 95% CI, 0.43-0.75; P <\/em>< 0.0001), ESCC (median 12.6 vs 9.8 mo; HR 0.72; 95% CI, 0.60-0.88; P<\/em> = 0.0006), CPS \u226510 (median 13.5 vs 9.4 mo; HR 0.62; 95% CI, 0.49-0.78; P<\/em> < 0.0001), and all pts (median 12.4 vs 9.8 mo; HR, 0.73, 95% CI, 0.62-0.86; P<\/em> < 0.0001). PFS was superior with pembro + chemo vs chemo in ESCC (median 6.3 vs 5.8 mo; HR 0.65; 95% CI, 0.54-0.78; P<\/em> < 0.0001), CPS \u226510 (median 7.5 vs 5.5 mo; HR 0.51; 95% CI, 0.41-0.65; P<\/em> < 0.0001), and all pts (median 6.3 vs 5.8 mo; HR 0.65; 95% CI, 0.55-0.76; P<\/em> < 0.0001). Confirmed ORR was 45.0% vs 29.3% (P<\/em> < 0.0001) in all pts, with median DOR of 8.3 vs 6.0 mo. Grade 3-5 drug-related AE rates were 72% vs 68%. Discontinuation rates from drug-related AEs were 19% vs 12%.<\/p>\n

Conclusions: <\/strong>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.<\/p>\n

Clinical trial identification: <\/strong>Clinicaltrials.gov identifier NCT03189719
Editorial acknowledgement: <\/strong>Luana Atherly-Henderson of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
Legal entity responsible for the study: <\/strong>Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
Funding: <\/strong>Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA<\/p>\n

Disclosure: <\/strong>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.<\/p>\n<\/div>\n

Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

LBA8_PR – Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study K. Kato1, J-M. Sun2, M.A. Shah3, P.C. Enzinger4, A. Adenis5, T. Doi6, T. Kojima7, J-P. Metges8, Z. Li9, S-B. Kim10, B.C. Chul Cho11, W. Mansoor12, S-H. Li13, P. Sunpaweravong14, M.A. Maqueda15, E. Goekkurt16, Q. […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-26385","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26385","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=26385"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26385\/revisions"}],"predecessor-version":[{"id":44147,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26385\/revisions\/44147"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=26385"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=26385"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=26385"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}