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Bristol Myers melanoma drug approved by FDA in immunotherapy advance

The Food and Drug Administration on Friday approved a new type of immunotherapy for skin cancer that's spread to other parts of the body or can't be removed surgically, clearing an infusion of Bristol Myers Squibb's drug Opdualag.

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While melanoma patients have a very good prognosis if their disease is caught early, survival rates are much lower after cancerous cells have spread through the body. Opdivo and Yervoy have proved capable of checking melanoma when it has advanced and Opdualag could help further.

The approval of Opdualag is another milestone for cancer immunotherapy, which over the past decade has become standard treatment for a wide range of cancers, including melanoma. That progress is due to the success of two types of drugs that target immune cell proteins which tumors can coopt to evade the body's attack. Yervoy, first approved in 2011, represents the first, while Opdivo is an example of the second.

The novel antibody contained in Opdualag, a drug known medically as relatlimab, is a third and its clearance by the FDA validates a new direction for immunotherapy research. Other drugmakers, including Merck & Co. and Regeneron, are also developing drugs like relatlimab, which are aimed at a protein dubbed LAG-3.

Adil Daud, a clinical professor at the University of California, San Francisco, called relatlimab a "major advance for immunotherapy," in a March 15 discussion of study results hosted by the American Society of Clinical Oncology.

In the clinical trial supporting Opdualag's approval, treatment with the drug reduced the risk of cancer progression or death by 25% versus Opdivo alone, a notable result given Opdivo's well-established benefit in treating melanoma. Updated results disclosed this month showed more trial participants responded to treatment with Opdualag than Opdivo, although the difference in survival rates between the two groups was not statistically significant.

Opdualag can cause a wide range of side effects similar to those associated with Opdivo alone. In about a fifth of participants, the side effects reported were judged to be more severe and, in 15% of volunteers, led to treatment discontinuation.

While higher than with Opdivo monotherapy, those rates of side effects are lower than with Opdivo and Yervoy together, a potent treatment combination that's considered a benchmark in treating metastatic melanoma. In a key study supporting Opdivo and Yervoy, side effects classified as Grade 3 or Grade 4 occurred in nearly 60% of volunteers.

In a Jan. 6 editorial accompanying the publication of Opdualag's results in The New England Journal of Medicine, two cancer doctors from the U.K. noted the potential for the drug to become the new standard of care in advanced melanoma should survival rates look similar to Opdivo plus Yervoy. While the final trial analysis didn't show a meaningful benefit, participants had not yet been followed for long enough to measure the median overall survival in those who received Opdualag.

Daud, in his Mar. 15 presentation, noted questions around Opdualag's long-term efficacy as well as uncertainty around which biomarkers might predict better responses.

For Bristol Myers, approval of Opdualag expands its immunotherapy business while giving it an opportunity to stake out a leading market position after losing ground to Merck and Swiss drugmaker Roche.

The drugmaker priced Opdualag at $27,389 per infusion for an adult, which it claimed in an emailed statement is "in line with other combination therapies for metastatic melanoma." The recommended treatment dose for adults is two vials every month until disease progression or unacceptable side effects occur.

Approval of Opdualag, which combines Bristol Myers' immunotherapy Opdivo with a novel antibody medicine it developed, gives doctors another option for treating metastatic melanoma that's more effective than Opdivo alone. Clinical trial results also indicated that Opdualag may be less toxic than a widely used combination of Opdivo with an older Bristol Myers drug called Yervoy.

Published March 21, 2022

Ned Pagliarulo, Lead Editor

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