Heinz-Josef Lenz, MD, FACP, associate director, Clinical Research, chair, Gastrointestinal Oncology Program, codirector, Colorectal Center, University of Southern California Norris Comprehensive Cancer Center; professor, Department of Medicine, Department of Preventive Medicine, Division of Oncology, Keck School of Medicine, discusses findings from an expanded efficacy analysis from the phase 3 CheckMate 8HW trial (NCT04008030). CheckMate 8HW evaluated frontline nivolumab (Opdivo) plus ipilimumab (Yervoy) vs chemotherapy in patients with previously untreated, microsatellite instability–high (MSI-H)/mismatch repair–deficient (dMMR) metastatic colorectal cancer (mCRC). At the 2024 ASCO Annual Meeting , Lenz and colleagues presented further data from this randomized phase 3 study, which enrolled patients with unresectable or metastatic CRC with MSI-H/dMMR status confirmed by local testing.
Participants were randomly assigned in a 2:2:1 fashion to receive nivolumab at 240 mg plus ipilimumab at 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab at 480 mg every 4 weeks; the same regimen of nivolumab as a single agent; or chemotherapy with or without targeted therapies. Treatment continued until disease progression or unacceptable toxicity, or for up to two years in the nivolumab arms. The primary endpoints were progression-free survival (PFS) by blinded independent central review (BICR) assessment per RECIST 1.
1 criteria for nivolumab plus ipilimumab vs chemotherapy in th.
