FDA Accepts sBLA for Treatment Combo for Certain Metastatic Colorectal Cancers


Nivolumab plus ipilimumab demonstrated clinical benefit in previously treated patients with dMMR or MSI-H metastatic colorectal cancer.

Officials with the FDA recently accepted Bristol-Myers Squibb Company’s supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of adults 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, according to a press release.

The application is based on data from the ongoing phase 2 CheckMate-142 study evaluating the treatment combination in previously treated patients with MSI-H or dMMR mCRC. The data were presented in January at the 2018 Gastrointestinal Cancers Symposium and published in the Journal of Clinical Oncology.

In the study, patients received mCRC combination dosing of nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for 4 doses, followed by nivolumab (3 mg/kg) every 2 weeks until disease progression, death, or unacceptable toxicity. The cohort included 119 patients with a median follow-up of 13.4 months.

The primary endpoint of objective response rate per investigator assessment was 55%. Response rates were durable, with median duration of response not yet reached and 94% of responses ongoing at the time of data cutoff. The overall survival (OS) rate at 1 year was 85% and median OS was not yet reached.

“The combination of Opdivo and Yervoy may represent an important advance for these distinct biomarker-defined patients, who historically have poorer outcomes compared to metastatic colorectal cancer patients whose tumors are mismatch repair proficient or microsatellite stable,” Thierry Andre, MD, head of the Medical Oncology Department in St. Antoine Hospital, Assistance Publique Hopitaux de Paris, said in a press release about the study.

Approximately 15% of CRC patients and 4% to 5% of metastatic CRC patients have MSI-H or dMMR biomarkers, according to the press release. Patients with MSI-H or dMMR metastatic CRC are less likely to benefit from conventional chemotherapy and typically have a poor prognosis, according to the release.

The FDA granted the application priority review and previously granted the combination Breakthrough Therapy Designation for this potential indication. According to Bristol-Myers Squibb, the FDA action is estimated to be July 10, 2018.


1. US Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for Previously Treated Patients with MSI-H or dMMR Metastatic Colorectal Cancer for Priority Review [news release]. Princeton. Bristol-Myers Squibb’s website. https://news.bms.com/press-release/bmy/us-food-and-drug-administration-fda-accepts-bristol-myers-squibbs-application-opdi. Accessed April 2, 2018.

2. Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Clinical Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer [news release]. Princeton. Bristol-Myers Squibb’s website. https://news.bms.com/press-release/corporatefinancial-news/opdivo-nivolumab-combination-yervoy-ipilimumab-demonstrates-cl. Accessed April 2, 2018.

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