Dr. Fakih on Efficacy With Regorafenib Plus Nivolumab in Metastatic CRC

Marwan Fakih, MD, medical director of the Judy & Bernard Briskin Center for Clinical Research and co-director for the Gastrointestinal Cancer Program at the City of Hope Comprehensive Cancer Center, discusses efficacy reported with regorafenib (Stivarga) plus nivolumab (Opdivo) in patients with mismatch repair–proficient and microsatellite stable metastatic colorectal cancer (CRC).

In a phase 2 study (NCT04126733) that examined the combination in this patient population, the difference in response achieved by those with and without liver metastases was quite significant, according to Fakih. Among the 70 patients enrolled to the trial, 47 had liver metastases; no responses to the combination were observed in this subset. Of the 23 patients without liver metastases, 5 experienced an objective response to the regimen and 35% achieved stable disease, Fakih says. The median progression-free survival was 3.5 months in the subset of patients without liver metastases, Fakih notes.

These data may suggest that a combination comprised of a PD-1 inhibitor and a VEGFR inhibitor may not be an effective option for patients with CRC without liver metastases. As such, more work is needed to investigate new combinations that can potentially improve outcomes in this subset, Fakih concludes.