Approvals

This indication has been approved under the Accelerated Approval pathway based on the tumour response rate and durability of response (DOR), however continued approval for this indication may depend on the outcome of some confirmatory trials.

This approval marks the first of an anti-PD-1 therapy in combination with an antibody-drug conjugate in the US for this indication. This is based on data from the Keynote-869 trial, which assessed the dose escalation with three cohorts (the dose escalation cohort, cohort A and cohort K). The median follow-up time for the dose escalation cohort and cohort A was 44.7 months, whereas for cohort K it was 14.8 months. The median DOR for the dose escalation cohort and cohort A was 22.1 months, whereas for cohort K it was not reached.

Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck, commented: “This approval is a major milestone in the treatment of patients with locally advanced or metastatic urothelial carcinoma because it is the first approved combination of an immunotherapy and an antibody drug conjugate for these patients. This expands the use of Keytruda-based regimens to more patients with advanced urothelial carcinoma and demonstrates the value of collaboration in creating new combination approaches for patients in need of more options.”