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Re: DewDiligence post# 430

Saturday, 09/19/2020 12:15:32 PM

Saturday, September 19, 2020 12:15:32 PM

Post# of 875
Keytruda monotherapy in adjuvant-melanoma—>statsig DMFS* benefit @3.5 years:

https://www.businesswire.com/news/home/20200919005015/en

Merck…and the European Organisation for Research and Treatment of Cancer (EORTC) today announced new and updated findings from the Phase 3 EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA…as adjuvant therapy in resected, high-risk stage III melanoma.

Late-breaking, first-time study results showed that with 3.5 years of follow-up, adjuvant KEYTRUDA met the key secondary endpoint of distant metastasis-free survival (DMFS), reducing the risk of distant metastasis or death by 40% versus placebo (HR=0.60 [95% CI, 0.49-0.73]; p<0.001), with 3.5-year DMFS rates of 65.3% and 49.4%, respectively.

Keytruda monotherapy is already FDA-approved in adjuvant melanoma with lymph-node involvement, based on the study mentioned above (#msg-146940594).

*Distant Metastases-Free Survival.

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