Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its drug Opdivo, in combination with Yervoy, as therapy for adults with advanced melanoma. The recommendation will next be reviewed by the European Commission (EC), which approves medicines for use in the European Union.
Melanoma, a form of skin cancer that develops from pigmented cells, is relatively easy to treat in early stages, but once it has metastasized and become an advanced cancer, treatment is more challenging and generally requires multidisciplinary approaches.
Immunotherapy is an approach that activates and stimulates the immune system to destroy melanoma cells. So far, various immunotherapeutic strategies have been developed, among them Opdivo (nivolumab), an inhibitory antibody that blocks the PD-1-PD-L1 pathway, uncovering tumor cells and allowing the immune system to attack and destroy them.
The CHMP’s recommendation for approval comes from the positive data of two trials, CheckMate -067 and CheckMate -069, as well as supportive data from the CA209-004 study.
CheckMate -067 was a Phase 3 trial designed to evaluate Opdivo in combination with Yervoy, or Opdivo monotherapy versus Yervoy monotherapy, in advanced untreated melanoma patients. The study evaluated progression-free survival (PFS) and overall survival (OS) in trial participants.
CheckMate -069 is a Phase 2 study designed to evaluate Opdivo in combination with Yervoy versus Yervoy monotherapy in untreated unresectable or metastatic melanoma patients. The study is investigating objective response rate (ORR), PFS, safety, and OS in this patient population.
CA209-004 is a Phase 1b study evaluating the combination of Opdivo and Yervoy in patients with advanced melanoma.
“Our pioneering Immuno-Oncology science began with the study of Yervoy in advanced melanoma. This scientific knowledge led to the development of Opdivo, which is now an important treatment option for patients with advanced melanoma. Now, we continue our progress in finding new treatment options for this devastating disease through the study of the combination of these two Immuno-Oncology agents. We are pleased the CHMP has recommended approval of Opdivo in combination with Yervoy in a broad melanoma patient population, and look forward to the European Commission’s decision,” Jean Viallet, MD, Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, said in a press release.
In the United States, nivolumab is approved for the treatment of patients with metastatic squamous non-small cell lung cancer whose disease continues to progress during or after chemotherapy, and for previously treated unresectable or metastatic melanoma patients.
In Europe, an estimated 100,000 people are diagnosed with melanoma each year.