Bristol-Myers Receives FDA Approval For Opdivo + Yervoy Regimen

Bristol-Myers Squibb’s combination immunotherapy drug has been approved by the United States Food and Drug Administration to treat a type of skin cancer. “We are now witnessing a turning point in cancer history, based on the significant impact immuno-oncology is making in the lives of patients with metastatic melanoma”, Tim Turnham, executive director, Melanoma Research Foundation, said in a statement.

The combination was approved through an accelerated pathway based on tumor response rate and durability of response.

The FDA approval for this combination therapy is based on results from the pivotal study CheckMate 069, a Phase 2 trial evaluating Opdivo plus Yervoy versus Yervoy alone in previously untreated patients with advanced melanoma.

Opdivo is a PD-1 checkpoint inhibitor and Yervoy is a CTLA-4 checkpoint inhibitor.

Today’s announcement marks the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.

Results showed that the confirmed objective response rate in patients with BRAF wild-type disease was 60% (95% CI: 48-71; P 0.001) with nivolumab plus ipilimumab compared with 11% (95% CI: 3-25) in patients treated with ipilimumab alone. Complete responses were reported in 17% of patients, while a partial response was observed in 43% of the patients in the Opdivo plus Yervoy group.

Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, other adverse reactions; infusion reactions; and embryofetal toxicity.

The combination of Yervoy, which was approved in 2011, and Opdivo caused serious side effects in 62 percent of study participants, compared with 39 percent of those who got only Yervoy, and many of those patients had to stop or delay treatment. “For the first time patients will have access to a regimen that utilizes two critical findings-that the patient’s own immune system can be engaged in the fight against cancer, and that the right combination of two or more drugs can have a synergistic effect”.