SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides

Progression-free Survival (PFS)

Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as ≥ 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score.

Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Complete Response Rate

Percentage of subjects with a complete response in the skin based on mSWAT

Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Time to Progression

Time from date of randomization until the earliest date of confirmed progression

Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Time to Maximal Effect in mSWAT

Time to greatest improvement in mSWAT score

Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)

Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration

Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days

Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose

Time frame: 28 days after first dose

Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months

Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose

Time frame: 4 months after first dose

Time to ≥ 50% Improvement in mSWAT

Time from date of randomization until ≥ 50% improvement in mSWAT score

Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Duration of Response in Skin

Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT)

Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Pruritus Medication Utilization

Change from baseline in number of pruritus medications taken per subject

Time frame: Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months