Merck & Co. details positive late-stage data for Keytruda in adjuvant melanoma

Merck & Co. announced Sunday that Keytruda (pembrolizumab) significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 43 percent compared to placebo, in a Phase III study as adjuvant therapy in patients with resected, high-risk stage III melanoma. The data from the KEYNOTE-054 trial, which the company said in January hit its main goal, were presented at the American Association for Cancer Research (AACR) annual meeting.

The study randomised 1019 patients with resected high-risk melanoma to receive adjuvant therapy with Keytruda or placebo. The trial's co-primary endpoints were RFS for all patients and RFS in patients whose tumours express PD-L1, while secondary goals include distant metastases-free survival and overall survival in the two populations.

Results, which were also published in the NEJM, showed that in the overall study population, the one-year RFS rate was 75.4 percent for Keytruda versus 61 percent for placebo. Merck added that for the co-main goal of RFS in patients whose tumours were considered PD-L1 positive, Keytruda demonstrated significantly prolonged RFS compared to placebo, with RFS rates of 77.1 percent and 62.6 percent, respectively.

Detailed results indicated that the benefits of Keytruda were similar in patients with PD-L1-positive and -negative tumours. Results showed that among the 852 patients with PD-L1-positive tumours, those given Merck's drug were 46 percent less likely to have a recurrence or death event compared to placebo, while among the 116 patients with PD-L1-negative tumours, those administered Keytruda were 53 percent less likely to have a recurrence or death event.

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Study investigator Alexander Eggermont remarked "an important aspect of this trial is that patients randomised to placebo who have recurrence are offered access to [Keytruda]." Eggermont noted that the cross-over design "will permit us to analyse if adjuvant therapy with [Keytruda] right after surgery is better or not than treating only those who relapse and start treatment at relapse."

Roy Baynes, head of global clinical development at Merck, said "these are the first data for Keytruda in the adjuvant setting and mark an important advancement for the treatment of resected stage III melanoma." Keytruda is currently approved for the treatment of patients with unresectable or metastatic melanoma, with Merck noting that it is working to expand approval of the anti-PD-1 therapy with the submission of data from the KEYNOTE-054 study to regulatory agencies in the US and around the world.

Last year, the product generated sales of $3.8 billion, with analysts at Credit Suisse predicting that revenue from Keytruda will surpass $10 billion in 2022. For related analysis, see ViewPoints: King Keytruda the apple of Merck & Co.'s eye.

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