FDA News

FDA grants priority review to Opdivo-Yervoy combination for colorectal cancer subtype

The FDA granted priority review to nivolumab plus ipilimumab for the treatment of adults with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan, according to a manufacturer-issued press release.

The agency previously granted breakthrough therapy designation for the combination of nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 checkpoint inhibitor — and ipilimumab (Yervoy, Bristol-Myers Squibb), an anti-CTLA-4 antibody.

The FDA based the priority review designation on the phase 2 CheckMate-142 study of nivolumab plus ipilimumab in 119 patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.

Approximately 15% of patients with colorectal cancer and 4% to 5% of patients with metastatic colorectal cancer have microsatellite instability-high or mismatch repair-deficient biomarkers.

Conventional chemotherapy is less likely to confer benefit for these patients, who typically have a poor prognosis.

As HemOnc Today previously reported, interim results from this study were presented at the Gastrointestinal Cancers Symposium.

Nivolumab plus ipilimumab yielded a preliminary ORR of 55% (95% CI, 45.2-63.8) and disease control rate of 80% (95% CI, 71.5-86.6). Three percent of patients achieved a complete response, 51% achieved a partial response and 31% showed stable disease.

Researchers reported a manageable safety profile in a subset of 84 patients with more than 6 months of follow-up.

Grade 3 or grade 4 treatment-related adverse events occurred among 32% of patients. Additionally, 13% of patients with adverse events of any grade and 10% of those with grade 3 or grade 4 adverse events discontinued treatment. No treatment-related deaths occurred.

“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 microsatellite instability-high or mismatch repair-deficient biomarkers, and is a result of our longstanding commitment to the exploration of immuno-oncology/immuno-oncology combinations for patient populations with high unmet need,” Ian M. Waxman, MD, development lead of gastrointestinal cancers at Bristol-Myers Squibb, said in the release. “We look forward to working with the FDA with the goal of bringing this combination to these [patients with colorectal cancer].”

The FDA assigned an action date of July 10 for this review.

The FDA granted priority review to nivolumab plus ipilimumab for the treatment of adults with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan, according to a manufacturer-issued press release.

The agency previously granted breakthrough therapy designation for the combination of nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 checkpoint inhibitor — and ipilimumab (Yervoy, Bristol-Myers Squibb), an anti-CTLA-4 antibody.

The FDA based the priority review designation on the phase 2 CheckMate-142 study of nivolumab plus ipilimumab in 119 patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.

Approximately 15% of patients with colorectal cancer and 4% to 5% of patients with metastatic colorectal cancer have microsatellite instability-high or mismatch repair-deficient biomarkers.

Conventional chemotherapy is less likely to confer benefit for these patients, who typically have a poor prognosis.

As HemOnc Today previously reported, interim results from this study were presented at the Gastrointestinal Cancers Symposium.

Nivolumab plus ipilimumab yielded a preliminary ORR of 55% (95% CI, 45.2-63.8) and disease control rate of 80% (95% CI, 71.5-86.6). Three percent of patients achieved a complete response, 51% achieved a partial response and 31% showed stable disease.

Researchers reported a manageable safety profile in a subset of 84 patients with more than 6 months of follow-up.

Grade 3 or grade 4 treatment-related adverse events occurred among 32% of patients. Additionally, 13% of patients with adverse events of any grade and 10% of those with grade 3 or grade 4 adverse events discontinued treatment. No treatment-related deaths occurred.

“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 microsatellite instability-high or mismatch repair-deficient biomarkers, and is a result of our longstanding commitment to the exploration of immuno-oncology/immuno-oncology combinations for patient populations with high unmet need,” Ian M. Waxman, MD, development lead of gastrointestinal cancers at Bristol-Myers Squibb, said in the release. “We look forward to working with the FDA with the goal of bringing this combination to these [patients with colorectal cancer].”

The FDA assigned an action date of July 10 for this review.

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