Abstract 1224P
Background
We conducted a prospective observational study to evaluate the real-world effectiveness of nivolumab (Nivo) monotherapy in previously treated advanced gastric cancer (GC) (Gastric Cancer 2021). Pre-planned 2-year final analysis was performed to confirm survival and tumor behavior of Nivo treatment.
Methods
The DELIVER trial enrolled 501 patients (pts) with advanced gastric or GEJ adenocarcinoma treated with Nivo alone from Mar 2018 to Aug 2019 (UMIN000030850). Primary endpoint was overall survival (OS), secondary endpoints were response rate (RR), disease control rate, progression-free survival (PFS), tumor regression rate (TRR) / tumor progression rate (TPR) at 1st evaluation, tumor growth rate (TGR) which was calculated as a percentage increase in tumor volume during 1 month, and safety.
Results
487 pts were evaluable (median age 70y [26-90], 71% male, ECOG PS0/1/2 42/44/14%, No. of prior regimen 1/2/≥3 2/39/59%, 42% pts with ascites). Median OS was 5.8 months (m) (95%CI 5.3-6.9) with 1y-survival rate of 30% and 2y-survival rate of 14%, and median PFS was 1.8 m (95%CI 1.7-2.0). The RR was 14.5% in 282 pts with measurable lesions. The sub-group analysis of OS by clinical factors was the following: male/female; 6.5/5.1m (p=0.001), PS0/1/2; 8.7/5.6/2.5m(p<0.001), tub/por or sig; 8.1/5.2m (p<0.001), albumin<3.5/≥3.5; 4.2/8.8m (p<0.001), and with/without peritoneal metastases; 4.9/8.4m (p<0.001). Median OS and PFS by tumor response (CR or PR/SD/PD) were 32.8/11.4/4.2m and 13.9/11.7/3.8/1.5m, respectively. In 147 elderly pts aged ≥75-y, RR, PFS, and OS were 14.3%, 2.0m, and 6.5m, respectively, and the safety profile was comparable to pts aged <75-y. Median TRR and TPR were 20.0% and 26.7%, in 75 pts with tumor regression and 185 pts with tumor progression, respectively. The TGR decreased from 3.8 to 2.8 after Nivo introduction. There were no associations between PFS/OS and tumor burden or TGR at baseline before Nivo.
Conclusions
The final analysis confirmed the efficacy of Nivo for advanced GC pts in clinical practice, with comparable outcomes in the elderly pts. Nivo was effective regardless of tumor burden or TGR at pre-treatment in advanced GC.
Clinical trial identification
UMIN000030850 and 17/Jan/2018.
Editorial acknowledgement
Legal entity responsible for the study
Japan Clinical Cancer Research Organization.
Funding
Ono pharmaceutical Co. and Bristol-Myers Squibb.
Disclosure
Y. Sunakawa: Financial Interests, Personal, Invited Speaker: Eli Lilly Japan, Bristol-Byers Squibb, Chugai Pharmaceutical, Takeda, Taiho Pharmaceutical, Merck Biopharma, Daiichi Sankyo, Ono Pharmaceutical; Financial Interests, Personal and Institutional, Research Grant: Chugai Pharmaceutical, Taiho Pharmaceutical, Takeda, Eli Lilly Japan. Y. Kito: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Daiichi Sankyo. H. Yasui: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Chugai Pharma, Bristol-Myers Squibb, Daiichi Sankyo, Terumo, Eli Lilly Japan, Merck Biopharma, Yakult Honsha, Bayer Yakuhin; Financial Interests, Institutional, Invited Speaker: MSD, Daiichi Sankyo, Ono Pharmaceutical, Astellas Pharma. H. Kawakami: Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb Co. Ltd., Bayer Yakuhin Ltd, Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd, Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Merck Biopharma Co., Ltd., Takeda Pharmaceutical Co. Ltd., Yakult Pharmaceutical Industry, Teijin Pharma Ltd., Taiho Pharmaceutical Co. Ltd.; Financial Interests, Personal, Advisory Board: Daiichi Sankyo Co. Ltd.; Financial Interests, Personal, Other, Lecture: Glaxo Smith Kline K.K, Otsuka Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Research Grant, Investigator-Initiated Trial: Bristol-Myers Squibb Co. Ltd.; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical Co. Ltd, Eisai Co., Ltd., Kobayashi Pharmaceutical Co. Ltd., Parexel International Corp., PRA HEALTHSCIENCES, EPS Corporation., Kissei Pharmaceutical Co., Ltd., EPS International Co.,Ltd,., MSD K.K., Ono Pharmaceutical Co.,Ltd., PPD-SNBL K.K, SymBio Pharmaceuticals Limited., IQVIA Services JAPAN K.K., SYNEOS HEALTH CLINICAL K.K., Nippon Kayaku Co.,Ltd., EP-CRSU Co., Ltd., Mebix, Inc., Bristol-Myers Squibb K.K., Janssen Pharmaceutical K.K., Eisai Co., Ltd., AstraZeneca K.K., Mochida Pharmaceutical Co., Ltd., Covance Japan Inc., Japan Clinical Research Operations, Chugai Pharmaceutical Co.,Ltd., Takeda Pharmaceutical Co.,Ltd., GlaxoSmithKline K.K., Sanofi K.K., Nippon Boehringer Ingelheim Co.,Ltd., Sysmex Corporation, Medical Reserch Support, Eli Lilly Japan K.K., Amgen Inc., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., SRL, Inc., Daiichi Sankyo Co., Ltd.. T.E. Nakajima: Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, Bristol-Myers Squibb, Bayer Yakuhin, Pfizer Japan Inc., Yakult Honsha Co., Nipro Co, Sumitomo Dainippon Pharma Co., Ono Pharmaceutical Co., Taiho Pharmaceutical Co., Takeda Pharmaceutical Co., Chugai Pharmaceutical Co., Sanofi K.K., Nippon Kayaku Co, MSD K.K., Eli Lilly Japan K.K., Daiichi Sankyo Co., Merck Serono Co., Amgen, Novartis Japan; Financial Interests, Personal and Institutional, Funding: Chugai Pharmaceutical Co., Taiho Pharmaceutical Co., Sanofi K.K., Takeda Pharmaceutical Co., Eli Lilly Japan K.K., Nippon Kayaku Co.; Financial Interests, Personal and Institutional, Invited Speaker: Eli Lilly Japan K.K, Taiho Pharmaceutical Co., Ono Pharmaceutical Co., Eisai Co. K. Muro: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Ono, Chugai; Financial Interests, Personal, Invited Speaker: Eli Lilly, Ono, Daiichi Sankyo, Taiho, Bristol-Myers Squibb, Chugai, AstraZeneca, Amgen; Financial Interests, Institutional, Research Grant, Including local PI as role: Astellas, Amgen, Solasia Pharma, Sanofi, Daiichi Sankyo, Taiho, MSD, Parexel Internatinonal, Merck KGaA, Pfizer, Eisai, Ono, Novartis; Non-Financial Interests, Principal Investigator: Takeda. W. Ichikawa: Financial Interests, Personal, Invited Speaker: Merck BioPharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Yakult Honsha, AstraZeneca, Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, Taiho Pharmaceutical, Daiichi Sankyo, Shionogi. All other authors have declared no conflicts of interest.