Keytruda continues success with new Phase 3 data in adjuvant melanoma

pharmafile | April 16, 2018 | News story | Research and Development, Sales and Marketing Cancer, MSD, keytruda, melanoma, pharma, skinc cancer 

MSD has revealed new efficacy data for Keytruda (permbrolizumab) as an adjuvant therapy in the treatment of resected, high-risk stage III melanoma. It is the third such reveal in weeks, following the drug’s success as a monotherapy in NSCLC with any PD-L1 expression but failure as a combo therapy in unresectable or metastatic melanoma.

Findings from the Phase 3 trial, which was conducted in partnership with the European Organisation for Research and Treatment of Cancer, showed that the anti-PD-1 therapy met its primary endpoint by prolonging recurrence-free survival (RFS), reducing disease recurrence or death risk by 43% compared to placebo.

In the overall population of just over 1,000 patients, rate of RFS was 75.4% after one year versus 61% for placebo. In the 852 patients whose tumours were PD-L1 positive these rates rose to 77.1% and 62.6% respectively, and the group were 46% less likely to experience disease recurrence or death, compared to 53% in the 116 participants with PD-L1-negative tumours.

These benefits were also shown to be irrespective of BRAF mutation status. According to the firm, the findings make Keytruda the first therapy of its kind to demonstrate benefit in RFS across stage 3A, 3 B and 3C melanoma.

While MSD said the drug’s safety profile was consistent with what had been found in earlier studies, it did confirm that one trial participant died in the Keytruda group as a result of myositis.

“These data demonstrate compelling evidence that adjuvant treatment with Keytruda provides significant recurrence-free survival benefit after surgery in patients with high-risk Stage 3 melanoma,” said Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at MSD. “These are the first data for Keytruda in the adjuvant setting and mark an important advancement for the treatment of resected stage 3 melanoma. We are pleased to be sharing these data with global regulatory authorities.”

Keytruda generated $3.8 billion in sales during the course of 2017, and analysts predict it could go on to break the $10 billion mark by 2022.

Matt Fellows

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