FDA Approves Combination Therapy for Metastatic Colorectal Cancer

The US Food and Drug Administration (FDA) has granted approval of a combination therapy for the treatment of adult and pediatric patients with a type of metastatic colorectal cancer that has progressed.

Bristol-Myers Squibb’s nivolumab (Opdivo) 3 mg/kg plus low-dose ipilimumab (Yervoy) 1 mg/kg are now approved in combination for the treatment of adult and pediatric patients 12 years of age and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 

This approval is based on positive overall response rate and duration of response data from the ongoing phase II CheckMate-142 trial, which enrolled a total of 119 patients with MSI-H or dMMR mCRC. Among 82 patients who received prior treatment, 46% (95% CI: 35-58; n = 38/82) responded to the nivolumab plus ipilimumab treatment. Of these patients, 3.7% achieved a complete response, and 43% achieved a partial response. Among 38 responders, the median duration of response was not reached, 89% had responses of 6 months or longer, and 21% had responses of 12 months or longer. 

Additionally, 49% of all patients enrolled in the trial responded to treatment with nivolumab plus ipilimumab (95% CI: 39-58; n = 58/119). Among all patients, 4.2% achieved a complete response, and 45% achieved a partial response. The median duration of response was not reached in these 58 responders, 83% had responses of 6 months or longer, and 19% had responses of 12 months or longer. 

Researchers reported that 86% of patients received all 4 doses of nivolumab plus ipilimumab. Nivolumab was discontinued in 13% of patients and delayed in 45% of patients due to an adverse reaction. Serious adverse reactions occurred in 47% of patients. The trial is ongoing.

“Metastatic colorectal cancers with dMMR or MSI-H biomarkers can be difficult to treat and some patients may need additional options,” said Heinz-Josef Lenz, MD, FACP, Keck School of Medicine of University of Southern California in a Business Wirepress release (July 11, 2018). “The FDA’s approval of an I-O/I-O combination provides us with an encouraging approach to address this challenging disease in patients who have progressed following treatment with three standard chemotherapy options.”—Janelle Bradley