2020-04-27 06:57:17 MRK Merck
04/27/20 04/2706:57 04/27/2006:57 | Merck reports interim data from Cohort B of KEYNOTE-555 Phase 1 trialMerck announced the presentation of interim data from Cohort B of KEYNOTE-555, a Phase 1 trial evaluating a 400 mg every six-week 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 of 38.6% in patients who received KEYTRUDA 400 mg Q6W, the primary endpoint of the study. As previously announced, Merck resubmitted supplemental Biologics License Applications to the U.S. 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. |
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