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Merck’s Keytruda shows improved ORR in phase 2 renal cell carcinoma study

PBR Staff Writer Published 04 June 2018

A phase 2 trial assessing Merck’s Keytruda (pembrolizumab) demonstrated overall response rate (ORR) of about 40% as first-line therapy in patients with advanced clear cell renal cell carcinoma (RCC).

The interim data from the phase 2 KEYNOTE-427 study showed an ORR of 38.2% in patients who received Keytruda monotherapy as first-line therapy. It is the primary endpoint of the trial.

Keytruda is a humanized monoclonal antibody, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, to activate T lymphocytes to affect both tumor cells and healthy cells.

The lead study investigator David McDermott said: “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.”

The ORR was 50.0% in patients whose tumors expressed PD-L1 in a pre-specified and exploratory sub-group analysis based on PD-L1 status.

The ORR was 42% in patients with intermediate/poor prognostic risk in a pre-specified exploratory sub-group analysis based on the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk model.

Merck Research Laboratories chief medical officer and global clinical development head Roy Baynes said: “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.”

Keynote-427 is a single-arm, open-label, non-randomized, multi-cohort and phase 2 study designed to assess the safety and efficacy of Keytruda as as monotherapy in patients with advanced RCC who have not received prior systemic therapy.

The study’s primary endpoint is ORR, and secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety and tolerability.

In the Keynote-427 trial, Merck recruited 275 patients with advanced RCC across two cohorts, including patients with clear cell RCC in cohort A and patients with non-clear cell RCC in cohort B.