Treatment with avelumab induced durable responses among, and was well tolerated by, patients with advanced Merkel cell carcinoma, according to a study published in The Lancet Oncology.1
Avelumab is an investigational, anti-PD-L1 IgG1 monoclonal antibody. Oncogenesis is associated with Merkel cell polyomavirus integration and ultraviolet-radiation-induced mutations; researchers evaluated PD-L1/PD-1 pathway inhibition with avelumab in patients with stage 4 Merkel cell carcinoma that had progressed after chemotherapy.
For this international, open-label, phase 2 trial, investigators enrolled 88 patients with stage 4 chemotherapy-refractory Merkel cell carcinoma. All patients received avelumab every 2 weeks.
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Median follow-up was 10.4 months; 31.8% of patients achieved an objective response, including 8 complete responses and 20 partial responses.
At the time of analysis, 82% of the 28 responses were ongoing.
Four patients reported grade 3 treatment-related adverse events, including lymphopenia in 2 patients, elevated blood creatine phosphokinase in 1 patient, increased aminotransferase in 1 patient, and elevated blood cholesterol in 1 patient.
Serious treatment-related events were observed in 5 patients and included enterocolitis, infusion-related reaction, increased aminotransferase, chondrocalcinosis, synovitis, and interstitial nephritis.
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The findings suggest that PD-L1/PD-1 pathway inhibition with avelumab may represent a novel treatment option for patients with advanced Merkel cell carcinoma.
Reference
- 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 Sep 1. doi: 10.1016/S1470-2045(16)30364-3 [Epub ahead of print]