-Merck’s Keytruda 400mg in 6 weeks good vs 200mg in 3

Data showed the efficacy and safety of Keytruda 400 mg every six weeks (Q6W) comparable to approved 200 mg every three weeks (Q3W) regimen.

Resubmitted Supplemental Biologics License Applications (sBLAs) for KEYTRUDA Q6W Dosing Under Review with US FDA Across All Approved Adult Indications.

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of interim data from Cohort B of KEYNOTE-555, a Phase 1 trial evaluating a 400 mg every six-week (Q6W) dosing regimen for KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with metastatic melanoma. Results of the study – which represent the first clinical outcomes evaluating Q6W dosing for KEYTRUDA – demonstrated efficacy and safety comparable to findings from previous melanoma trials evaluating KEYTRUDA monotherapy. Interim data showed an overall response rate (ORR) of 38.6% (n=17/44) (95% CI, 24.4-54.5) in patients who received KEYTRUDA 400 mg Q6W, the primary endpoint of the study.

As previously announced, Merck resubmitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) to update the dosing frequency for KEYTRUDA to include a 400 mg Q6W option across all approved adult indications. The results of KEYNOTE-555 supported the resubmission. In the EU, 400 mg Q6W dosing for KEYTRUDA monotherapy was approved by the European Commission in March 2019.

“We remain committed to improving cancer care, which includes the ability to offer greater flexibility in administering KEYTRUDA,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “These data, coupled with extensive model-based assessments, provide strong evidence for a six-week dosing regimen for KEYTRUDA.”

Results from KEYNOTE-555 Cohort B will be presented tomorrow in an online plenary session at the American Association for Cancer Research (AACR) Virtual Annual Meeting I (Abstract #CT042).