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The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) for the treatment of adults and children aged 12 years and older with certain types of colorectal cancer (CRC).

Specifically, the combination is approved for those with metastatic microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) CRC, adding to the list of other indications for the combination therapy.

The FDA also converted the previously accelerated approval to regular approval for single-agent nivolumab for adults and children aged 12 years and older with MSI-H and dMMR CRC whose disease progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan, according to the FDA approval notice.

Approval of the nivolumab + ipilimumab combination — which received priority review, breakthrough therapy designation, and orphan drug designation — was based on findings from the randomized, open-label CHECKMATE-8HW trial showing improved progression-free survival (PFS) vs chemotherapy in the first-line setting, and improved PFS and overall response rate vs nivolumab alone in all settings.

Median PFS was not reached for nivolumab + ipilimumab, but was 5.8 months for investigators’ choice of chemotherapy (hazard ratio [HR], 0.21). Response and overall survival (OS) rates were not available at the time of the analysis.

Median PFS with nivolumab + ipilimumab vs nivolumab monotherapy was not reached vs 39.3 months, respectively (HR, 0.62), and the overall response rates were 71% and 58%, respectively. OS rates were not available at the time of the analysis.

Patients receiving combination nivolumab and ipilimumab received 240 mg nivolumab every 3 weeks plus 1 mg/kg ipilimumab every 3 weeks for up to four doses, followed by 480 mg of nivolumab every 4 weeks. Nivolumab monotherapy was given at a dose of 240 mg every 2 weeks for six doses, followed by 480 mg of nivolumab every 4 weeks.

Adverse events occurring in at least 20% of patients treated with nivolumab + ipilimumab were fatigue, diarrhea, pruritus, abdominal pain, musculoskeletal pain, and nausea. Those occurring in at least 20% of patients treated with nivolumab monotherapy included fatigue, diarrhea, abdominal pain, pruritus, and musculoskeletal pain.

The most common adverse reactions reported in ≥ 20% of patients treated with nivolumab with ipilimumab were fatigue, diarrhea, pruritus, abdominal pain, musculoskeletal pain, and nausea. The most common adverse reactions reported in ≥ 20% of patients treated with nivolumab as a single agent were fatigue, diarrhea, abdominal pain, pruritus, and musculoskeletal pain.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X @SW_MedReporter.