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news.The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol-Myers Squibb's Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
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The CHMP also added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with Yervoy is established only in patients with low tumor PD-L1 expression. This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union.
Opdivo monotherapy is already approved by the EC for advanced melanoma and previously treated advanced squamous non-small cell lung cancer (NSCLC), and was recommended for approval by the CHMP in February for previously treated advanced or metastatic non-squamous NSCLC and renal cell carcinoma (RCC).
Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, commented, "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."
The CHMP adopted the positive opinion based on data from two trials, CheckMate -067 and CheckMate -069, in addition to supportive data from CA209-004, a Phase 1b study which evaluated the combination of Opdivo and Yervoy in patients with advanced melanoma. CheckMate -067 is a Phase 3, double-blind trial which evaluated Opdivo in combination with Yervoy or Opdivo monotherapy vs. Yervoy monotherapy in patients with previously untreated advanced melanoma, and included patients with both BRAF V600 mutation-positive and wild-type advanced melanoma. The co-primary endpoints were PFS and overall survival (OS).
CheckMate -069 is a Phase 2, double-blind, randomized study which evaluated Opdivo in combination with Yervoy vs. Yervoy monotherapy in patients with previously untreated unresectable or metastatic melanoma, and included patients with both BRAF wild-type and BRAF V600 mutation-positive melanoma.
The primary endpoint was objective response rate (ORR) in patients with BRAF wild-type tumors. Secondary endpoints included PFS in patients with BRAF wild-type tumors, ORR in patients with BRAF V600 mutation positive tumors, and safety. Overall survival was an exploratory endpoint.
About Advanced Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease, and occurs when cancer spreads beyond the surface of the skin to the other organs, such as the lymph nodes, lungs, brain or other areas of the body. Melanoma is the ninth most common cancer in Europe, with an estimated 100,000 new cases diagnosed annually and more than 20,000 deaths.