Found 1 Presentation For Request "1227P"

Oesophagogastric cancer

1227P - Regorafenib (REGO) with nivolumab (NIVO) and FOLFOX in HER2 negative esophagogastric cancer (EGC)

Presentation Number
1227P
Speakers
  • Samuel Cytryn (New York, United States of America)
Date
Mon, 12.09.2022

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 >24 of 35 accrued patients to be progression free for the regimen to be considered promising. Secondary endpoints include objective response rate (ORR), safety, OS, clinical benefit, and exploratory biomarker analysis.

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>5 (5 of 8). Median PFS was not reached. 25 pts were evaluable for 6 mo PFS, of whom 18 (72%) reached a 6 mo PFS. Of the remaining 10 pts, nine are on treatment, but have not yet reached 6 mo and one has enrolled in the study but has not yet started therapy. Among the 34 pts on therapy, median follow up was 7.9 mo. The most common any-grade adverse events (AE) were Gr 1 neuropathy (47%), Gr 1 and 2 fatigue (47%, 44%), Gr 3 neutropenia (38%), and Gr 1 and 2 palmar plantar erythrodysethesia (32% each). 71% of patients had grade 3/4 AE; the most common were neutropenia (50%), hypertension (15%), and anemia (12%). 53% of pts required dose reductions of at least one medication and 24% required discontinuation. REGO was dose reduced in 32% of pts and discontinued in 12%. NIVO was discontinued in 9% of pts.

Conclusions

Updated ORR, PFS, OS and biomarker data will be presented. We noted a lower-than-expected CPS>5 positive rate in our cohort using PD-L1 IHC E1L3N compared to Checkmate 649 (PDL1 IHC 28.8) and Orient 16 (PD-L1 IHC 22C3) cohorts. The majority of patients had a response, irrespective of PDL1 status, with no new safety signals.

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.

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