Heinz-Josef Lenz, MD, FACP, discusses updated efficacy data from the phase 2 CheckMate-142 trial with nivolumab plus low-dose ipilimumab in metastatic colorectal cancer.
Heinz-Josef Lenz, MD, FACP, associate director of clinical research and associate director of adult oncology with Keck Medicine of University of Southern California Norris Comprehensive Cancer Center, discusses updated efficacy data from the phase 2 CheckMate-142 trial with nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) in metastatic colorectal cancer (mCRC).
The CheckMate-142 study enrolled patients with previously untreated microsatellite instability–high (MSI-H)/mismatch repair deficient (dMMR) mCRC. The clinical update has reconfirmed theencouraging clinical activity, which include complete clinical response rates, says Lenz. The median duration of response and progression-free survival (PFS) have yet to be reached, which Lenz explains is promising in a patient population who is known for not having good outcomes with chemotherapy. At the 2020 ASCO Virtual Scientific Program, the phase 3 KEYNOTE-177 data showed that there is a direct comparison between chemotherapy versus immunotherapy in MSI-H/dMMR mCRC.
What is further impressive about this study, Lenz says, is the progression-free survival (PFS) rate at 2 years, which is 74%, and the overall survival (OS) rate at 2 years, which is 79%, indicating that this patient population does extremely well with immunotherapy. Most importantly, ipilimumab, though it is often considered a toxic immune therapeutic agent but with this regimen—as it has shown in lung cancer and melanoma—the 1 mg/kg dose every 6 weeks does not change the toxicity profile. In fact, the adverse events observed in ipilimumab were the same compared with nivolumab alone.
This is a very well-tolerated and effective regimen with durable response rates, PFS, and OS data, and the National Comprehensive Cancer Network guidelines have already included the regimen as a potential treatment option in the first-line setting for patients with mCRC who do not tolerate chemotherapy. These data further support the use of this combination potentially in the first-line setting, concludes Lenz.