Merck’s KEYTRUDA (pembrolizumab) Showed Overall Response Rate of Nearly 40 Percent as First-Line Therapy

Merck 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).

“Until now, there have been limited data evaluating anti-PD-1 monotherapy in the first-line treatment of advanced clear cell renal cell cancer,” said Dr. David F. McDermott, lead study investigator, director, Biologic Therapy and Cutaneous Oncology Programs, Beth Israel Deaconess Medical Center, leader, Dana Farber/Harvard Cancer Center, Kidney Cancer Program, professor of medicine, Harvard Medical School. “With an overall response rate of nearly 40 percent as monotherapy, these data from KEYNOTE-427 are encouraging for clinicians and for patients living with this difficult-to-treat cancer.”

“We are pleased by the promising results for KEYTRUDA from KEYNOTE-427 – the first Phase 2 study to evaluate an anti-PD-1 therapy as first-line monotherapy for patients with advanced clear cell renal cell cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These findings support the continued evaluation of KEYTRUDA in the first-line setting, and we look forward to progressing ongoing studies in renal cell cancer investigating KEYTRUDA as both monotherapy and in combination with other therapies.”

Merck has an extensive clinical development program across RCC and is advancing multiple potential registration-enabling studies with KEYTRUDA, as monotherapy and in combination with other treatments, including KEYNOTE-564, KEYNOTE-426 and KEYNOTE-581.