Found 1 Presentation For Request "1227P"
1227P - Regorafenib (REGO) with nivolumab (NIVO) and FOLFOX in HER2 negative esophagogastric cancer (EGC)
- Samuel Cytryn (New York, United States of America)
Abstract
Background
NIVO plus chemotherapy demonstrated superior overall survival (OS) versus chemotherapy in metastatic EGC (Janjigian et al, Lancet 2021). We report preliminary results of a single center investigator initiated phase II study of first-line REGO with NIVO and FOLFOX in this population.
Methods
Patients (pts) with HER2 negative, untreated, metastatic EG adenocarcinoma, irrespective of PD-L1 status, received REGO (80 mg daily), NIVO (240 mg every 2 weeks), plus FOLFOX. PD-L1 clone E1L3N (Cell Signaling) was tested by IHC per standard MSK practice. The primary endpoint was 6-month (mo) progression free survival (PFS) with a goal of
Results
The study completed enrollment with a total of 35 pts. 90% of the 29 pts with RECIST 1.1 measurable disease had tumor regression (-5% to -100%). The ORR was 62% (16 PR, 2 CR) in the entire cohort, 62% ORR in pts with CPS<5 (13 of 21), and 63% ORR in pts with CPS
Conclusions
Updated ORR, PFS, OS and biomarker data will be presented. We noted a lower-than-expected CPS
Clinical trial identification
NCT04757363.
Legal entity responsible for the study
Memorial Sloan Kettering Cancer Center.
Funding
Bayer, Bristol-Myers Squibb, Memorial Sloan Kettering Cancer Center.
Disclosure
S. Cytryn: Financial Interests, Personal, Stocks/Shares: Pfizer, Moderna. G.Y. Ku: Financial Interests, Personal, Other, Provision of Services: Bristol-Myers Squibb, Dava Oncology, Merk & Co Inc, Eli Lilly and Company, Pieris. S.B. Maron: Financial Interests, Personal, Advisory Board: Natera, Bicara, Daiichi Sankyo, Novartis, Basilea; Financial Interests, Personal, Stocks/Shares: Calithera. D.H. Ilson: Financial Interests, Personal, Other, Provision of Services: Astellas, Bayer, Merk & Co Inc, Taiho. Y.Y. Janjigian: Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb, Merck Serono; Financial Interests, Personal, Advisory Board: RGENIX, Eli Lilly, Daiichi Sankyo, Pfizer, Bayer, Imugene, Merck, Zymeworks Inc., Seagen, Basilea Pharmaceutica, AstraZeneca; Financial Interests, Personal, Other, Consulting: Michael J. Hennessy Associates, Paradigm Medical Communications; Financial Interests, Personal, Stocks/Shares: RGENIX; Financial Interests, Personal and Institutional, Research Grant: NCI, Department of Defense, Cycle for Survival, Genetech/Roche, Fred's Team, RGENIX, Bayer, Bristol-Myers Squibb, Eli Lilly, Merck. All other authors have declared no conflicts of interest.