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domingo, 3 de junho de 2018

Merck's KEYTRUDAR (pembrolizumab) Showed Overall Response Rate of Nearly 40 Percent as First-Line Therapy in Patients with Advanced Clear Cell Renal Cell Carcinoma (RCC) in Phase 2 KEYNOTE-427 Study


First-Time KEYTRUDA Monotherapy Data in Clear Cell RCC to be Presented at 2018 ASCO Annual Meeting

KENILWORTH, N.J., June 3, 2018 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced interim results from Cohort A of KEYNOTE-427, a Phase 2 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as first-line treatment for advanced clear cell renal cell carcinoma (RCC). Interim data showed an overall response rate (ORR) of 38.2 percent (95% CI, 29.1-47.9) in patients who received KEYTRUDA monotherapy as first-line therapy, the primary endpoint of the study. In a pre-specified, exploratory sub-group analysis based on PD-L1 status, ORR was 50.0 percent (95% CI, 34.9-65.1) in patients whose tumors expressed PD-L1 (CPS ≥1). In a pre-specified exploratory sub-group analysis based on the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk model, ORR was 42.0 percent (95% CI, 30.2-54.5) in patients with intermediate/poor prognostic risk. This is the first presentation of Phase 2 data for an anti-PD-1 monotherapy as first-line treatment for advanced clear cell RCC. These results, as well as other study findings, are being presented today in an oral session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4500).
The attached news release crossed the wire today, Sunday, June 3, 2018 at 9:00 a.m. ET. 



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