Advanced melanoma: a combination of two immunotherapeutic agents, Opdivo and Yervoy, has received positive CHMP opinion
The Committee for Medicinal Products for Human Use ( CHMP ) of the EMA ( European Medicines Agency ) has recommended the approval of Opdivo ( Nivolumab ) in combination with Yervoy ( Ipilimumab ) for the treatment of advanced ( unresectable or metastatic ) melanoma in adults.
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.
Opdivo monotherapy is already approved by the EC ( European Commission ) for advanced melanoma.
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 Nivolumab and Ipilimumab in patients with advanced melanoma.
CheckMate -067 is a phase 3, double-blind trial which evaluated Nivolumab in combination with Ipilimumab or Nivolumab monotherapy versus Ipilimumab 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 progression-free survival and overall survival.
CheckMate -069 is a phase 2, double-blind, randomized study which evaluated Nivolumab in combination with Ipilimumab versus Ipilimumab 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 progression-free survival in patients with BRAF wild-type tumors, ORR in patients with BRAF V600 mutation positive tumors, and safety.
Overall survival was an exploratory endpoint.
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. ( Xagena )
Source: BMS, 2016