USA – Bristol-Myers Squibb (BMS) announced that the first drug in a new class of cancer immunotherapies has been approved by US FDA as an initial treatment for advanced melanoma, the deadliest form of skin cancer.
The Food and Drug Administration approved relatlimab, a LAG-3 inhibitor – short for lymphocyte-activation gene 3 – for use as an initial treatment for advanced melanoma in combination with Bristol’s blockbuster immunotherapy Opdivo.
In clinical trials, relatlimab, which will be marketed as Opdualag, more than doubled the time it took for advanced melanoma to worsen when compared to Opdivo alone, a metric known as progression-free survival.
In clinical trials, relatlimab, which will be marketed as Opdualag, more than doubled the time it took for advanced melanoma to worsen when compared to Opdivo alone, a metric known as progression-free survival.
The drug is Bristol Myers’ third approved cancer immunotherapy – drugs that use the body’s own defenses to fight tumors. Opdivo targets a protein known as PD-1. The drugmaker’s first such product, Yervoy, is a CTLA-4 inhibitor.
Currently, about one-third of advanced melanoma patients are treated with PD-1 monotherapy, including Merck & Co.’s Keytruda, according to BMS.
A third are getting Opdivo-plus-Yervoy, and the remaining third— mainly with BRAF mutations—use targeted therapies such as Novartis’ Tafinlar and Mekinist.
According to Chief Medical Officer Samit Hirawat, Relatlimab will only be used in conjunction with Opdivo.
According to Hirawat, LAG-3 inhibitors such as relatlimab can reinvigorate the immune system by restoring the function of “exhausted” T cells – a key component of the immune system – potentially improving Opdivo’s performance.
“Our hypothesis is that the best applicability of a LAG-3 inhibitor will be in combination with a PD-1 inhibitor” like Opdivo, he said.
The combination is expected to cost US$27,389 according to the company.
Bristol Myers said it expects the combination therapy to generate more than US$4 billion in sales per year by 2029.
Bristol Myers Squibb is testing the combination of Opdivo and relatlimab in other cancer types such as colorectal, lung, and liver cancer in the phase 3 RELATIVITY-098 trial.
The Opdualag approval comes on the heels of a high-profile melanoma failure for BMS.
Bempegaldesleukin, or bempeg, a long-acting interleukin-12 drug developed by Nektar Therapeutics that BMS paid US$1.85 billion upfront in 2018 to pair with Opdivo, failed in a phase 3 trial in first-line melanoma.
When combined with Opdivo, the drug failed to provide a benefit in tumor shrinkage, disease progression, or patient survival, dealing a blow to BMS’ I-O ambitions.
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