FDA Approves Opdualag, a New Fixed-Dose Combination Treatment, For Certain Patients With Skin Cancer


The FDA’s decision to greenlight Opdualag is based on data that showed that the combination more than doubled survival without disease progression when compared with Opdivo in patients with previously untreated metastatic or unresectable melanoma, a type of skin cancer.

The Food and Drug Administration (FDA) approved Opdualag, a fixed-dose combination of Opdivo (nivolumab) and relatlimab-rmbw, as a treatment option for children and adults aged 12 years or older with unresectable or metastatic melanoma, a type of skin cancer, according to Bristol Myers Squibb.

“(This) approval is exciting news and offers new hope to the melanoma community,” Michael Kaplan, the president and CEO of Melanoma Research Alliance, said in a news release. “The availability of this treatment combination may enable patients to potentially benefit from a new, first-in-class dual immunotherapy.”

The FDA based its decision to OK Opdualag in this patient population using data from the phase 2/3 RELATIVITY-047 trial. Earlier this week, the trial’s authors presented newly released findings that showed that at a median follow-up of 19.3 months, treatment with Opdualog induced a median progression-free survival (the time during and after treatment when the patient lives without disease progression) of 10.22 months in 355 patients. That finding was still more than double the median progression-free survival of 4.63 months that was associated with the single-agent use of Opdivo among 359 patients.

Moreover, the use of the combination was associated with an improvement in overall survival and objective response rates (the proportion of patients who had a complete or partial response to treatment).

Any-severity side effect occurred in 99.2% of the patients treated with the combination compared with 95.8% in those who received Opdivo alone. Serious or severe side effects were reported in 43.4% of those given the combination and 35.1% on Opdivo. Nine percent of patients in the group that received the combination had to discontinue treatment as a result of serious or severe treatment-related side effects, compared with 3.6% who were administered the single-agent.

At the time of the presentation of the additional seven months of follow-up data, lead study author Dr. Georgina Long, chair of melanoma medical oncology & translation research at University of Sydney in Australia said, “(Opdivo) plus relatlimab had a manageable safety profile, with no new or unexpected safety signals. These data further validate (Opdivo) plus relatlimab as a potential new treatment option in patients with advanced melanoma and support the benefit of dual checkpoint inhibition.”

Now just days later, patients with previously untreated metastatic or unresectable melanoma have a new treatment option available to them.

“Since the approval of the first immune checkpoint inhibitor more than 10 years ago, we’ve seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma,” Dr. F. Stephen Hodi, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute in Boston, said in the release. “(This) approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints — LAG-3 and PD-1.”

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