The immunotherapy Relatlimab will be used in combination with the company’s already approved Opdivo.
On Friday the Food and Drug Administration (FDA) approved Bristol Myers Squibb’s (BMS) cancer immunotherapy as a first line treatment for advanced melanoma in patients 12 and older. The drug which is the first of its class is expected to generate over $4 billion in annual sales. Samit Hirawat, BMS Chie Medical Officer stated, “The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.” The lymphocyte-activation gene (LAG) 3 inhibitor will be used in combination with the company’s immunotherapy Opdivo. Hirawat said, “Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab (Opdivo), represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients.”
The FDA granted approval based on results from a Phase II/III study which enrolled over 700 participants. The participants in the study were randomised to either a combination treatment or Opdivo as a single therapy. Relatlimab doubles the time it takes for an advanced melanoma to worsen compared to Opdivo when administered on its own. "Our hypothesis is that the best applicability of a LAG-3 inhibitor will be in combination with a PD-1 inhibitor" like Opdivo Hirawat noted. He further added that LAG-3 inhibitors can revive the immune system by repairing the function of “exhausted” T cells. BMS expects the combination therapy to cost $27,389. Opdivo and relatlimab are being tested as a combination therapy in other cancer types such as lung, colorectal and liver cancer.