A New Bristol-Myers Squibb Combination Therapy Now Available officially recognized The FDA offers a new treatment option for patients with severe melanoma. The decision also opens the door to a class of cancer immunotherapies targeting new targets.
The approval, announced late Friday, covers the treatment of patients 12 and older whose melanoma cannot be surgically removed or has spread. The therapy pairs the new drug relatlimab with the approved BMS drug Opdivo. The combination of the two drugs is administered as a single intravenous infusion. BMS will market relatlimab under the name “Opdualag”.
Opdivo and Opdualag block so-called checkpoint proteins that keep T cells from recognizing and fighting tumors. While both drugs are checkpoint inhibitors, they each block a different checkpoint protein. Opdivo targets PD-1; Opdualag targets lymphocyte activation gene 3 or LAG-3. The idea is that blocking both checkpoint proteins could lead to a better immune response.
The FDA’s decision was based on results from a Phase 2/3 study that enrolled 714 patients. The participants were randomly assigned to receive the combination therapy or Opdivo alone. The primary goal was to measure progression-free survival—how long a patient lived without the disease getting worse. The results showed that median progression-free survival was 10.1 months in the combination arm and 4.6 months in the Opdivo arm. Preliminary results from the study were reported about a year ago, More detailed data presented at American Society of Clinical Oncology 2021 Annual Meeting.
The new BMS drug does come with warnings that the treatment could lead to a series of serious and potentially fatal immune responses. Opdivo’s drug label carries a similar warning. In clinical testing, BMS reported that Opdualag’s safety profile was similar to Opdivo’s previously reported.
Opdualag’s regulatory green light gives BMS its third approved checkpoint inhibitor. Yervoy, which targets CTLA-4, was first approved in 2010 for the treatment of advanced melanoma. Four years later, Opdivo was first approved, also for advanced melanoma.
“Inhibition of LAG-3 with relatlimab, in a fixed-dose combination with nivolumab (Opdivo), represents a new therapeutic approach that builds on our ability to provide patients with Building on a legacy of bringing innovative immunotherapy options.” . “The approval of a new drug containing our third unique checkpoint inhibitor marks an important step in providing patients with more options beyond monotherapy.”
BMS isn’t the only company developing LAG-3 inhibitors. Merck is looking for favezelimab, which it is testing in combination with its approved PD-1-blocking blockbuster drug Keytruda, as a treatment for colorectal cancer. Meanwhile, Immutep is evaluating its LAG-3 inhibitor eftilagimod alpha in several different types of cancer, including a head and neck squamous cell carcinoma study that is testing the drug in combination with Keytruda.
Public domain image by Julio C. Valencia National Cancer Institute
