Dr. Lenz on the Safety Profile in CheckMate-142 Trial in CRC

Heinz-Josef Lenz, MD, FACP, professor of medicine, J. Terrance Lanni Chair in Gastrointestinal Cancer Research, and co-director, University of Southern California (USC) Center for Molecular Pathway and Drug Discovery, at the USC Norris Comprehensive Cancer Center, discusses the safety profile of nivolumab (Opdivo) plus ipilimumab (Yervoy) in the phase II CheckMate-142 trial for treatment-naive patients with microsatellite instability—high/mismatch repair deficient colorectal cancer (CRC).

Results of the phase II CheckMate-142 trial showed an overall response rate (ORR) of 64%, and 84% of patients had disease control for ≥12 weeks. Median duration of response, progression-free survival, and overall survival have not been reached.

In the past, higher doses and more frequent administration of ipilimumab led to significant gastrointestinal-related toxicities in patients with CRC. However, the dosing for this nivolumab/ipilimumab combination is different than prior studies that the combination have been investigated in, according to Lenz. When ipilimumab was given at 1 mg every 6 weeks, there were no additional adverse events compared with when nivolumab was given alone, concludes Lenz.