The Food and Drug Administration (FDA) granted priority review to the combination use of Opdivo (nivolumab) and Yervoy (ipilimumab) to treat a subgroup of patients with metastatic colorectal cancer.
The Food and Drug Administration (FDA) granted priority review to the combination use of Opdivo (nivolumab) and Yervoy (ipilimumab) to treat a subgroup of patients with metastatic colorectal cancer, according to a press release issued by Bristol-Myers Squibb, the agents’ manufacturer.
The indication is intended for those with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer, who have progressed on fluoropyrimidine, oxaliplatin and irinotecan regimens.
The agency set an action date for the combination regimen — which was previously granted Breakthrough Therapy designation for this patient population – for July 10, 2018.
The priority review is based on a supplemental Biologics License Application that included data from the ongoing, phase 2 CheckMate-142 study, which was published in the Journal of Clinical Oncology and recently presented at the 2018 Gastrointestinal Cancers Symposium. In the study, the combination — which is currently approved for patients with metastatic colorectal cancer who progressed after chemotherapy – appeared to be safe and effective, while providing durable responses and disease control among the treated population.
“The FDA acceptance of this application with priority review reinforces our belief in the potential of the Opdivo plus Yervoy combination to treat patients with previously treated metastatic colorectal cancer defined by MSI-H or dMMR biomarkers, and is a result of our longstanding commitment to the exploration of (double immunotherapy regimen) combinations for patient populations with high unmet need,” Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb, said in the release.
“We look forward to working with the FDA with the goal of bringing this combination to these colorectal cancer patients,” he added.
The occurrence of dMMR happens when the repair mechanism for DNA replication is not working properly, which in turn, leads to MSI-H status among tumors. Approximately 4 to 5 percent of patients with metastatic colorectal cancer test positive for dMMR or MSI-H biomarkers, according to the release.
An eventual approval of this combination may offer hope to individuals with MSI-H or dMMR-positive disease, since these patients are less likely to respond to traditional chemotherapy, leading to poor prognosis.
As more new agents move in to the colorectal cancer space, it is crucial that everyone diagnosed undergoes genetic testing, according to John Marshall, M.D., chief of the Division of Hematology/Oncology at MedStar Georgetown University Hospital, professor of medicine and oncology at the Lombardi Comprehensive Cancer Center at Georgetown University, and director of the Otto J. Ruesch Center for the Cure of Gastrointestinal Cancer.
“Over the last decade, we’ve gone from only a certain number of patients that should be tested, to today, where everyone should be tested — stage 1 to 4 – should be tested,” Marshall said in an interview with CURE.
Testing positive for MSI-H or dMMR status not only has treatment implications, but it also may reveal a genetic cancer risk that a patient has, leading their family members to undergo genetic testing, too.