FDA approve's Merck's Keytruda in patients with recurring carcinoma
Merck announced that the FDA has approved KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, based on the results of the Cancer Immunotherapy Trials Network's CITN-09/KEYNOTE-017 trial. In this Phase 2 trial of 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease, KEYTRUDA monotherapy demonstrated an objective response rate of 56 percent, with a complete response rate of 24 percent and a partial response rate of 32 percent. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Patients received KEYTRUDA 2 mg/kg every three weeks until unacceptable toxicity or disease progression that was symptomatic, rapidly progressive, required urgent intervention, occurred with a decline in performance status, or was confirmed at least four weeks later with repeat imaging. Patients without disease progression were treated for up to 24 months. Assessment of tumor status was performed at 13 weeks followed by every nine weeks for the first year and every 12 weeks thereafter. The major efficacy outcome measures were objective response rate and duration of response as assessed by blinded independent central review per RECIST v1.1.