Real-world data on the use of nivolumab plus chemotherapy for patients with metastatic GC/GEJC/EAC: A Canadian perspective

BackgroundIn Canada, patient access to novel therapeutics can take up to 2 years. Patient support programs (PSP) can provide earlier access to new treatments following regulatory approval. We analysed real-world data from the Canadian PSP that offered first-line nivolumab and chemotherapy (NIVO+chemo) for HER2-negative metastatic gastric cancer (mGC), gastroesophageal junction cancer (mGEJC) and esophageal adenocarcinoma (mEAC).MethodsDemographic, clinical, and disease data were collected during PSP enrolment. All patients provided informed consent. This descriptive analysis summarized continuous measures using medians (interquartile range; IQR) and categorical measures using frequencies and proportions.ResultsA total of 731 eligible patients were enrolled between Nov 1, 2021 and Oct 31, 2022 and 706 patients received NIVO+chemo: 66.7% were male; median age 67 years (IQR 60-74); 49.4% were treated in Ontario, 21.4% in Quebec, 22.7% in Western and 6.5% in Atlantic provinces; 62.2% had mGC, 23.1% mGEJC and 14.7% mEAC. NIVO was initiated at 240 mg or 3 mg/kg Q2W in 84.4% of patients and 360 mg or 4.5 mg/kg Q3W in 15.2%; assumed to reflect the choice of backbone chemo, i.e., FOLFOX and CAPOX, respectively. 96% of patients remained on initial dosage while 1.8% switched to 480mg Q4W. 344 patients (48.7%) ended treatment during the 12-month PSP while 362 (51.3%) were still on therapy at the end of the PSP and were transferred to the public system. The main reasons for discontinuation were HCP decision (55.2%), death (18.6%) and disease progression (16.3%). Among 344 patients who discontinued treatment during the PSP, the median duration of therapy was 5.2 months [IQR 2.5-8.3].ConclusionsIn the span of 1 year, over 700 patients were treated with NIVO+chemo in this PSP, demonstrating the unmet medical need in this population. Patient baseline demographics and disease characteristics were similar to those reported in the pivotal study CheckMate 649, although more patients were assumed to have received FOLFOX, based on NIVO Q2W dosing, in the PSP (84%) than in the clinical study (54%), highlighting this as the preferred chemotherapy backbone in Canada. Limitations of this study are those inherent to a PSP.Legal entity responsible for the studyBristol Myers Squibb.FundingBristol Myers Squibb.DisclosureM. Tehfe: Financial Interests, Personal, Advisory Board: BMS, Merck, Pfizer, Taiho, Incyte; Financial Interests, Personal, Invited Speaker: BMS, Taiho; Financial Interests, Institutional, Local PI: BMS, Amgen, Novartis, BioNTech; Financial Interests, Institutional, Research Grant: Pfizer, Taiho. S. Snow: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Amgen, Astellas, Merck, Janssen, AstraZeneca, Taiho, BeiGene, Knight, GSK, Takeda, Lilly, Sanofi, Roche, Pfizer; Financial Interests, Institutional, Local PI: Merck, Amgen, Arcus, BMS, Sanofi, Novartis; Non-Financial Interests, Leadership Role, President of Board of Directors: Lung Cancer Canada. H. Lim: Financial Interests, Personal, Advisory Board, Honoria: BMS; Financial Interests, Personal, Advisory Board: Deciphera, Astellas, BeiGene, Taiho, Eisai, Amgen, Pfizer, CADTH, Merck, AstraZeneca, Roche; Financial Interests, Personal, Other, Beta-tester for system: Varian; Financial Interests, Institutional, Research Grant: Roche. E. Elimova: Financial Interests, Personal, Invited Speaker: Roche, Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: BeiGene, Signatera, AbbVie, Astellas, Viracta Tx; Financial Interests, Institutional, Steering Committee Member, Institution receives: Jazz; Financial Interests, Institutional, Local PI: Jazz, Zymeworks, Amgen, AstraZeneca, BMS, Trio-Oncology; Other, A family member employed by Merck Vaccines: Merck. F. Brellier: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. N. Dourdin: Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. C. Brezden-Masley: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Bristol Myers Squibb, Gilead Sciences, Merck, Eli Lilly, Novartis, Pfizer, BeiGene; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Institutional, Local PI: Astellas, AstraZeneca, Gilead Sciences; Financial Interests, Institutional, Research Grant: Pfizer, Novartis, Eli Lilly; Financial Interests, Institutional, Steering Committee Member: Novartis; Financial Interests, Institutional, Coordinating PI: Seagen; Non-Financial Interests, Member of Board of Directors: My Gut Feeling, ReThink Breast Cancer; Non-Financial Interests, Advisory Role: Colorectal Cancer Resource and Action Network; Non-Financial Interests, Member: ASCO, MASCC, CCON, CAMO; Non-Financial Interests, Leadership Role: ICOS.