BAVENCIO® (avelumab) Study Design

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BAVENCIO® (avelumab) was studied in the largest clinical trial of immunotherapy in mMCC1,2

BAVENCIO was studied in the JAVELIN Merkel 200 trial, a Phase 2, open-label, single-arm, multinational, multicenter trial

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According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as measured by blinded independent central review committee.
†Assessed by independent central review committee.
  • BAVENCIO was administered at 10 mg/kg IV infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity
  • Patients with radiological disease progression not associated with significant clinical deterioration could continue treatment
  • Tumor response assessments were performed every 6 weeks
  • The efficacy analysis was conducted when the last patient enrolled had completed 12 months of follow-up

Absence of significant clinical deterioration was defined as no new or worsening symptoms, no change in performance status for > 2 weeks, and no need for salvage therapy.

References: 1. Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016;17(10):1374-1385. 2. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/results?term=%22merkel+cell+carcinoma%22+AND+%22immune%22&Search=Search. Accessed August 25, 2017.