FDA grants priority review of Opdivo plus Yervoy in previously untreated advanced melanoma

Source: Healio.com/dermatology, September 2015

The FDA has accepted a supplemental biologics license application for the Opdivo plus Yervoy regimen to include data from a phase 3 trial of patients with previously untreated advanced melanoma, according to a press release from Bristol-Myers Squibb.

The agency also granted priority review of the application, with a target action date of Jan. 23, according to the release

”Findings from CheckMate -067 provide additional evidence that the combination of the two immuno-oncology agents, Opdivo [nivolumab] and Yervoy [ipilimumab], may provide improved outcomes for patients with advanced melanoma, and has the potential to become the basis of how this devastating disease is treated,” Michael Giordano, senior vice president, head of development for oncology at Bristol-Myers Squibb, said in a press release. “We saw significant clinical benefit from the Opdivo+Yervoy regimen in these patients, including an increase in the time patients lived without disease progression, and we look forward to working with the FDA to review this data.”

The CheckMate -067 study is the first phase 3 trial evaluating nivolumab plus ipilimumab or nivolumab vs. ipilimuamb monotherapy in previously untreated patients with advanced melanoma, regardless of BRAF status, according to the release. The application would expand upon the initial application for the combined regimen, which was based on tumor response rate and safety data from a phase 2 randomized trial.

Patients in the ongoing phase 3 trial will continue to be followed for overall survival, which is the study’s primary endpoint.

Severe adverse events reported with nivolumab, a monoclonal antibody and PD-1 checkpoint inhibitor, include immune-mediated pneumonitis, colitis, hepatitis, nephritis and renal dysfunction, hypothyroidism and hyperthyroidism and embryofetal toxicity, according to the release.

Severe adverse events reported with ipilimumab, also a monoclonal antibody and immune checkpoint inhibitor, include immune-mediated enterocolitis, hepatitis, dermatitis, neuropathies, and endocrinopathies, the release reported.