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. Author manuscript; available in PMC: 2021 Apr 1.
Published in final edited form as: Int Ophthalmol Clin. 2020 Spring;60(2):91–102. doi: 10.1097/IIO.0000000000000306

Table 1.

JAVELIN Merkel 200 trial data of avelumab for the treatment of mMCC. The trial comprises two cohorts: individuals with disease refractory to chemotherapy (Part A), and patients with no prior systemic therapy for mMCC (Part B).

Trial Design Subjects Dosage Median Treatment Duration Selected Outcomes
Phase II

JAVELIN Merkel 200, Part A(Second-line or later therapy) Multicenter, international,open-label,single-arm 88 10 mg/kg 3.9 m Confirmed ORR: 33.0%
Complete response: 11.4%
2-year PFS: 26%
2-year OS: 36%
Median OS: 12.6 m
Clinical activity independent of PD-L1 or MCPyV status
JAVELIN Merkel 200, Part B(First-line therapy) Multicenter, international,open-label,single-arm, pre-planned interim analysis 39 10 mg/kg 12 w Confirmed ORR: 62.1%
Complete response: 13.8%%
3-month PFS: 67%a
Median PFS: 9.1 ma

Dosing of avelumab in both parts of this trial was by intravenous infusion every two weeks.

*

Number of subjects in the dose escalation cohort, 18 of whom were included in dose-limiting toxicity analysis set. 53 were then included in the dose-escalation safety analysis set, who were then combined with 33 patients from the dose-expansion part of the same trial to comprise 86 patients assess for pharmacokinetic parameters.

From expanded data from this cohort in patients with ≥ 2 years follow up

In subset of 29 patients with at least 3 months follow up

a

Of cohort of all 39 treated patients

mMCC, metastatic Merkel cell carcinoma; Mg, milligrams; kg, kilograms; w, weeks; m, months; ORR, objective response rate; PFS, progression-free survival; OS, overall survival; PD-L1, programmed death-ligand 1; MCPyV, Merkel cell polyoma virus