BMS celebrates a new day in cancer treatment with the approval of Opdualag

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Every week, BioSpace reports on incremental advances in cancer treatment, and while they may seem like that to the average eye, they mean a lot to these patients. But on Friday Bristol Myers Squibb took a monumental step when the U.S. Food and Drug Administration Opdualag approved (nivolumab and relatlimab-rmbw) for treatment of patients aged 12 years and over with unresectable or metastatic melanoma.

In addition to adding another valuable weapon against melanoma, the FDA decision officially validates LAG-3 as a clinically effective checkpoint inhibitor – the first since the Merck’s Keytruda approval in 2014.

The decision, announced Friday afternoon, is based on the Phase II/III RELATIVITY-047 trial, which compared Opdualag (a combination therapy of relatlimab and nivolumab) to nivolumab alone. data, presented in March by BMS, showed that Opdualag met the primary endpoint of progression-free survival (PFS) in first-line metastatic or unresectable melanoma. And it definitely more than doubled the median PFS compared to treatment with only nivolumab (Opdivo), to the tune of 10.1 months versus 4.6 months. This was the first-ever data ever announced from a phase III trial of an LAG-3 antibody.

In a previous interview with BioSpace, Dr. Frédéric Triebel, MD, Ph.D., who discovered LAG-3 in 1990, noted these results were “very convincing” and “very significant”. Triebel is Scientific Director and Chief Medical Officer at Immutep.

“Since the approval of the first immune checkpoint inhibitor more than 10 years ago, we have seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma,” noted F. Stephen Hodi, MD, director of the Melanoma Center and the Center for Immuno-Oncology at the Dana-Farber Cancer Institute. “Today’s approval is particularly significant as it introduces an entirely new combination of two immunotherapies that can work together to help improve anti-tumor response by targeting two different immune checkpoints – LAG-3 and PD. -1.”

The very first checkpoint inhibitor to be approved by the FDA was BMS’s anti-CTLA-4 mAb Yervoy (ipilimumab) in 2011. Yervoy’s first approved indication was also metastatic melanoma. Since then, it has been given the green light for a number of other indications, including hepatocellular carcinoma (in combination with Opdivo) and Non-small cell lung cancer (with Opdivo).

Opdivo, BMS’s lead cancer drug, has been FDA approved in 2014 – just a few months after competitor Keytruda. Like Keytruda, it is a PD-1 inhibitor. It works by blocking PD-1 (Programmed Cell Death Protein 1), which is a cellular pathway. PD-1 inhibits the immune response – essential to the body’s ability to fight cancer. Blocking this pathway revives this much-needed response.

LAG-3 regulates an inhibitory immune control pathway that limits the activity of T cells – another key player in the immune response – impairing their ability to attack and destroy tumor cells. A drug like Opdualag that counteracts this could restore the effector function of depleted T cells and lead to more remissions, hence the interest in combining the two mechanisms.

“While we have made great strides in the treatment of advanced melanoma over the past decade, we are committed to expanding dual immunotherapy treatment options for these patients,” said Samit Hirawat, Medical Director of Global Drug Development. drugs at BMS, in a press release. “LAG-3 inhibition with relatlimab, in fixed-dose combination with nivolumab, represents a new therapeutic approach that builds on our heritage of bringing innovative immunotherapy options to patients.”

Opdualag joins Opdivo and Yervoy in BMS’s arsenal of single checkpoint inhibitors. Based on recent history, this new addition is only expected to increase the company’s dominance in cancer immunotherapy.

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