Dr. Lenz on the Rationale for the CheckMate 9X8 Trial in Metastatic CRC

Heinz-Josef Lenz, MD, FACP, associate director, Clinical Research, J. Terrence Lanni Chair in Gastrointestinal Cancer Research, co-director, University of Southern California (USC) Center for Molecular Pathway and Drug Discovery, professor of medicine and preventive medicine, co-director, Colorectal Cancer, co-director, USC Norris Center for Cancer Drug Development, co-leader, Gastrointestinal Cancers Program, USC Norris Comprehensive Cancer Center, section head, GI Oncology, Division of Medical Oncology, Keck School of Medicine of USC, discusses the rationale for the phase 2/3 CheckMate 9X8 trial (NCT03414983) in metastatic colorectal cancer (mCRC).

The standard of care for the frontline treatment of patients with mCRC includes a fluoropyrimidine with oxaliplatin and/or irinotecan and a targeted agent, Lenz says. However, data suggest that adding immunotherapy could improve upon the efficacy of standard treatments.

As such, the CheckMate 9X8 trial randomized patients with untreated, unresectable mCRC to nivolumab (Opdivo) plus modified FOLFOX6 (mFOLFOX6) and bevacizumab (Avastin) vs mFOLFOX6 plus bevacizumab alone. The primary end point of the study was progression-free survival (PFS) by blinded independent central review per RECIST v1.1 criteria. Patients were stratified by tumor location with the goal of gleaning insight into the potential prognostic value of tumor location, Lenz explains.

The results of the phase 2 trial, which were presented during the 2022 Gastrointestinal Cancers Symposium, demonstrated that the primary end point of the study was not met, Lenz concludes.