Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Phase 3 Completed 432 enrolled Gilead Sciences

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.

Timeline

Start: 2015-10-13
Primary completion: 2019-05-15
Completion: 2019-05-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Andecaliximab + mFOLFOX6 vs Placebo + mFOLFOX6; p = 0.5625; Cox Proportional Hazard 0.93 (95% CI 0.74 to 1.18) NCT02545504 ↗

Publications

Background Shah MA, Bodoky G, Starodub A, Cunningham D, Yip D, Wainberg ZA, Bendell J, Thai D, He J, Bhargava P, Ajani JA. Phase III Study to Evaluate Efficacy and Safety of Andecaliximab With mFOLFOX6 as First-Line Treatment in Patients With Advanced Gastric or GEJ Adenocarcinoma (GAMMA-1). J Clin Oncol. 2021 Mar 20;39(9):990-1000. doi: 10.1200/JCO.20.02755. Epub 2021 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Andecaliximab	Monoclonal antibody	800 mg	Intravenous
Background	Leucovorin	Small molecule	—	Intravenous
Background	Oxaliplatin	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous