FDA grants priority review to Keytruda for stage II resected high-risk melanoma
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The FDA granted priority review to pembrolizumab for adjuvant treatment of certain patients with high-risk melanoma.
The designation applies to use of the agent by patients aged 12 years or older with stage IIB or IIC melanoma who underwent complete resection.
The FDA is expected to make a decision on approval by Dec. 4.
The agency based the priority review on results of the randomized phase 3 KEYNOTE-716 trial, which included 954 patients aged 12 years or older with completely resected high-risk stage II melanoma.
In the first part of the study, patients received pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — or placebo every 3 weeks for up to 17 cycles. Adults received 200 mg pembrolizumab via IV, and pediatric patients received 2 mg/kg pembrolizumab via IV (200 mg maximum).
In the second part of the study, eligible patients — either those who recurred after receiving placebo, or those who completed 17 cycles of pembrolizumab and did not experience recurrence within 6 months of treatment completion — received up to 35 additional cycles of pembrolizumab.
RFS served as the primary endpoint. Secondary endpoints included distant metastasis-free survival, OS and quality of life.
Interim analysis results showed pembrolizumab conferred a statistically significant and clinically meaningful RFS benefit, according to a Merck-issued press release. Researchers observed no new safety signals.
Complete results will be presented at a medical meeting.
“KEYNOTE-716 is the first phase 3 study to evaluate adjuvant therapy solely for stage IIB and IIC melanoma — an area with high unmet need,” Jason J. Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center and a HemOnc Today Next Gen Innovator, said in the release. “By moving immunotherapy with Keytruda to earlier stages of melanoma, we have the opportunity to reduce the risk of recurrence for high-risk stage II patients compared to observation alone following complete resection.”
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