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D'Angelo et al. 1227P - Avelumab treatment in chemotherapy-naïve patients with distant metastatic Merkel cell carcinoma (mMCC)


MCC is a rare, aggressive skin cancer. In a phase 2 study of patients with mMCC progressed on or after chemotherapy (JAVELIN Merkel 200; NCT02155647), avelumab (a human anti–PD-L1 antibody) showed durable responses and a manageable safety profile, including an objective response rate (ORR) of 33.0%, proportion of responses with ≥1-year duration of 74% (Kaplan-Meier estimate), and estimated 1-year overall survival (OS) rate of 52%. Based on these results, avelumab was approved by the US FDA in March 2017 and is the only approved treatment for patients with mMCC. Here, we report early interim results from patients with mMCC receiving first-line avelumab.


Eligible patients with mMCC and no prior systemic treatment for metastatic disease received avelumab 10 mg/kg Q2W. Tumors were assessed every 6 weeks (RECIST v1.1) by independent review committee (IRC). Adverse events (AEs) were assessed by NCI CTCAE v4.0.


At data cutoff on Dec 30, 2016, 29 of 112 planned patients had been enrolled. Median follow-up was 3.1 months (range 0.3–8.5) and median duration of treatment was 8.1 weeks (range 2.0–37.9). Of 16 patients with ≥13 weeks of follow-up, confirmed ORR by IRC was 62.5% (95% CI 35.4–84.8) with response ongoing in all 10 patients, including in all 5 patients with ≥6 months of follow-up. Of 25 patients with ≥6 weeks of follow-up, unconfirmed ORR by IRC was 68.0% (95% CI 46.5–85.1); responses were ongoing at last follow-up in 16 of 17 responders (94.1%; 1 censored due to other therapy). 23 of 29 patients (79.3%) had a treatment-related AE (TRAE), including 5 (17.2%) with a grade 3 or 4 TRAE. There was 1 immune-mediated TRAE (grade 1 rash). 5 patients (17.2%) discontinued avelumab due to a TRAE. There were no treatment-related deaths. Updated analyses of 39 patients will be presented (n = 29 and n = 14 with ≥13 weeks and ≥6 months of follow-up, respectively; data cutoff Mar 24, 2017), including PFS and OS analyses.


First-line avelumab treatment resulted in early responses and a high ORR in distant mMCC, substantiating prior findings with second-line or later avelumab treatment. Most responses were ongoing, including all responders with ≥6 months of follow-up. Enrollment is ongoing.

Clinical trial identification

NCT02155647 EMR100070-003

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany; Pfizer Inc, New York, NY, USA.


Merck KGaA, Darmstadt, Germany; Pfizer Inc, New York, NY, USA.