Abstract 1444P
Background
Nivolumab, an anti-PD-1 antibody, was approved in 2017 as a treatment for unresectable advanced or recurrent gastric cancer that had progressed following ≥2 lines of chemotherapy. Subsequently, post-marketing surveillance was implemented to collect real-world safety and efficacy data. This is the first real-world data on immune checkpoint inhibitors from >600 gastric cancer patients.
Methods
This surveillance comprised a multi-centered, open-labeled, non-interventional, observational cohort study. Patients with unresectable advanced or recurrent gastric cancer that had progressed after ≥2 lines of chemotherapy were enrolled in the study from November 1st, 2017 to October 31st, 2018. The data were collected using a case report form. The observation period was 6 months.
Results
In total, 654 patients were enrolled in this surveillance study. The safety and efficacy analysis sets included 650 and 636 patients, respectively. The background characteristics of the patients were as follows: 73% were male, the median age was 69 years, 90% had an ECOG performance-status score of 0 or 1, the median number of previous treatment regiments was 2.0, and 18% had large amounts of ascites before starting nivolumab treatment. The incidence of adverse drug reactions (ADRs) was 32%. The four most frequent ADRs (>2%) were diarrhea (3.7%), decreased appetite (2.9%), rash (2.5%), and malaise (2.3%). The incidence of ADRs that were grade 3 or above was 11%, and the most frequent ADRs were decreased appetite and diarrhea (0.92% each). In addition, 0.9%, 9.3%, 23%, and 55% of patients showed complete response, partial response, stable disease, and progressive disease, respectively. The overall survival rate at 6 months was 43% (95% CI: 39.5%-47.4%).
Conclusions
The real world data of Japanese patients with unresectable advanced or recurrent gastric cancer showed safety profile and efficacy of nivolumab consistent to those reported in the ATTRACTION-2 study.
Clinical trial identification
JapicCTI-184070, 20-Aug-2018.
Editorial acknowledgement
Legal entity responsible for the study
Ono Pharmaceutical Company.
Funding
Ono Pharmaceutical Company, Bristol-Myers Squibb.
Disclosure
N. Boku: Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self): Taiho Pharmaceutica; Honoraria (self): Bristol-Myers Squibb. K. Yamaguchi: Honoraria (institution), Speaker Bureau/Expert testimony: Daiichi-Sankyo; Honoraria (institution), Speaker Bureau/Expert testimony: Taiho Pharmaceutical; Honoraria (institution), Speaker Bureau/Expert testimony: Chugai Pharm; Speaker Bureau/Expert testimony: Bristol-Myers Squibb Japan; Honoraria (institution), Speaker Bureau/Expert testimony: Ono Pharmaceutical; Speaker Bureau/Expert testimony: Takeda; Honoraria (institution), Speaker Bureau/Expert testimony: Lilly; Honoraria (institution), Speaker Bureau/Expert testimony: Sanofi; Honoraria (institution): MSD oncology; Honoraria (self): Dainippon Sumitomo Pharma; Advisory/Consultancy: Gilead Sciences; Honoraria (institution): Boehringer Ingelheim; Honoraria (institution): Eisai; Honoraria (institution): Yakult Honsha. K. Muro: Research grant/Funding (institution): Parexel International; Research grant/Funding (institution): Merck Serono; Advisory/Consultancy, Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Sumitomo Dainippon Pharma; Research grant/Funding (institution): Shionogi; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Mediscience Planning; Research grant/Funding (self): Solasia Pharma; Honoraria (self): Taiho; Honoraria (self): Chugai; Honoraria (self): Eli Lilly; Honoraria (self): Takeda; Honoraria (self), Advisory/Consultancy: Ono; Honoraria (self): Sanofi; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Bayer; Advisory/Consultancy: AstraZeneca. K. Yoshida: Honoraria (self), Research grant/Funding (institution): Asahi Kasei Pharma; Honoraria (self), Research grant/Funding (institution): Chugai Pharm.; Honoraria (self), Research grant/Funding (institution): Covidien Japan; Honoraria (self), Research grant/Funding (institution): Daiichi Sankyo; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Research grant/Funding (institution): Eli Lilly Japan; Honoraria (self), Research grant/Funding (institution): Johnson & Johnson; Honoraria (self), Research grant/Funding (institution): MerkSerono; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Nippon Kayaku; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Ono Pharm.; Honoraria (self), Research grant/Funding (institution): Otsuka Pharm.; Honoraria (self), Research grant/Funding (institution): Sanofi; Honoraria (self), Research grant/Funding (institution): Taiho Pharm; Honoraria (self), Research grant/Funding (institution): Takeda Pharm.; Honoraria (self), Research grant/Funding (institution): Tsumura; Honoraria (self), Research grant/Funding (institution): Yakult Honsha; Research grant/Funding (institution): Abbott; Research grant/Funding (institution): Abbvie; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Biogen Japan; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): GlaxoSmithKline; Research grant/Funding (institution): KCI; Research grant/Funding (institution): Koninklijke Philips; Research grant/Funding (institution): Kyowa Kirin; Research grant/Funding (institution): Meiji Seika Pharma; Research grant/Funding (institution): Toray Medical; Honoraria (self): AstraZeneka; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Denka; Honoraria (self): EA Pharma; Honoraria (self): Olympus; Honoraria (self): Pfizer; Honoraria (self): Sanwa Kagaku Kenkyusho; Honoraria (self): SBI Pharma; Honoraria (self): Teijin Phamra; Honoraria (self): Terumo. H. Baba: Speaker Bureau/Expert testimony: Eli Lilly Japan K.K.; Speaker Bureau/Expert testimony: Taiho Pharmaceutical Co, Ltd.; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Ono Pharmaceutical Co., Ltd.; Research grant/Funding (institution): Taiho Pharmaceutical Co, Ltd; Research grant/Funding (institution), The company name changed to \"Merck Biopharma Co., Ltd\" in April 2019.: Merck Serono Co, Ltd.; Research grant/Funding (institution): MSD K.K. ; Research grant/Funding (institution): Yakult Honsha Co.,Ltd.; Research grant/Funding (institution): Chugai Pharmaceutical Co, Ltd.; Research grant/Funding (institution): Shin Nippon Biomedical Laboratories, Ltd.. S. Tanaka, A. Akamatsu: Full/Part-time employment: Ono Pharmaceutical. T. Sano: Honoraria (self): Ono Pharmaceutical; Honoraria (self): TAIHO Pharmaceutical; Honoraria (self): Eli Lilly Japan ; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): EA Pharma ; Honoraria (self): Daiichi Sankyo Company; Honoraria (self): Takeda Pharmaceutical; Honoraria (self): Nippon Kayaku .