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

^aOf 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