The findings, according to the study’s lead author, justify the use of Opdivo plus relatlimab as a new treatment option for patients with advanced melanoma, a form of skin cancer.
An additional seven months of follow-up data show that the use of Opdivo (nivolumab) plus relatlimab continues to be associated with better outcomes that Opdivo alone in the treatment of patients with previously untreated metastatic or unresectable melanoma, a type of skin cancer.
The newly released findings from the phase 2/3 RELATIVITY-047 trial, which were presented during the March 2022 American Society of Clinical Oncology Plenary Series, demonstrate that the combination continues to elicit a progression-free survival (the time during and after treatment when the patient lives without disease progression) benefit, as well as improve overall survival and objective response rates (the proportion of patients who had a complete or partial response to treatment) in this patient population.
“(Opdivo) plus relatlimab had a manageable safety profile, with no new or unexpected safety signals,” lead study author Dr. Georgina Long, chair of Melanoma Medical Oncology & Translational Research at University of Sydney in Australia, said during a presentation of the study results. “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.”
In 2021, the Food and Drug Administration (FDA) granted a priority review to an application seeking approval of the combination treatment in certain patients with unresectable or metastatic melanoma who are aged 12 years and older. The application is supported by earlier results from the RELATIVITY-047 trial, which demonstrated that Opdivo plus relatlimab more than doubled the median progression-free survival compared with Opdivo alone, at 10.2 months versus 4.63 months, respectively.
Of note, a priority review designation by the FDA ensures that more attention and resources will be directed to the application of a drug that, if approved, would be a significant upgrade over current treatment methods.
The FDA plans to decide on the approval of Opdivo plus relatlimab within this patient population by March 19, 2022.
The study authors enrolled 714 patients with previously untreated, unresectable, or metastatic melanoma onto the RELATIVITY-047 trial to assess the safety and efficacy of a fixed-dose (which is the combination of two drugs into a single dose) of Opdivo and relatlimab versus Opdivo alone.
The authors’ main goal was to evaluate if treatment with Opdivo plus relatlimab would result in a significant improvement of progression-free survival among the study participants. Additionally, other goals were to see if the combination led to better overall survival and objective response rate outcomes.
At a median follow-up of 19.3 months, the updated results showed that treatment with the combination induced a median progression-free survival 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. This result indicated that the use of the combination translated to a 22% reduction in the risk of disease progression or death.
Overall survival rates were higher in the combination group than those who received Opdivo alone at 12, 24 and 36 months (77% versus 71.6%; 63.7% versus 58.3%; 55.8% versus 48.8%, respectively).
Moreover, the addition of relatlimab to Opdivo resulted in an improved objective response rate of 43.1% compared with 32.6% in those who were treated with single-agent Opdivo.
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.
Treatment-related side effects that patients receiving the combination most commonly experienced included increased urge to scratch oneself (any severity, 24.5%), fatigue (any severity, 23.4%), rash (any severity, 16.6%), joint stiffness (any-grade, 14.9%) diarrhea (any severity, 14.9%) and vitiligo (any severity, 12.7%), a disease that causes the loss of skin color in patches.
A version of this story first appeared on OncLive® as, “Relatlimab/Nivolumab Combo Continues to Impress in Previously Untreated Metastatic or Unresectable Melanoma.”
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