A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma

Response rate is percentage of participants with confirmed CR or PR as per modified Severity-Weighted Assessment Tool (mSWAT) for MF group; mSWAT and Sezary count for SS group. mSWAT is a weighted sum of percent (%) of total body surface area attributed to skin lesions which yield a mSWAT score \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks; PR: ≥50% mSWAT score reduction from baseline). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline). Response rate is calculated as total number of participants with CR or PR from the start of study treatment until PD or recurrence divided by the number of participants treated, then multiplied by 100.

Time frame: Baseline to measured Progressive Disease (PD) [up to 9 cycles (28-day cycles)]

Population: All participants who received at least 1 dose of study drug.

The Itchy QoL is a non-validated 22-item questionnaire designed to assess pruritus-associated symptoms with a 7-day recall using 3 domains: Emotions (9 items), Functions (7 items) and Symptoms domain (6 items). Each Itchy QoL item was evaluated by level of itch frequency through the use of a 5-point adjectival scale 1 (never), 2 (rarely), 3 (sometimes), 4 (often), 5 (all the time). Unweighted means were calculated individually for the 3 domains each with scores range from 1 to 5 and the total score is expressed as the mean of the three dimension scores and ranges from 1 (no itch) to 5 (worst imaginable itch).

Time frame: Baseline, up to study completion [up to 9 cycles (28-day cycles)], end of treatment reported

Population: Enrolled participants who had a baseline and at least 1 post-baseline Itchy QoL observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary.

Time from first confirmed response \[Complete Response (CR) or Partial Response (PR)\] until Progressive Disease (PD) as per mSWAT for MF group; mSWAT and Sezary count for SS group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks; PR: ≥50% reduction in mSWAT score from baseline; PD: ≥25% of mSWAT score from nadir). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline; PD: ≥40% of Sezary cells from nadir). Responders or those who died without PD were censored at date of last progression-free disease assessment. Responders who received subsequent systemic anticancer therapy were censored at date of last progression-free disease assessment prior to post-discontinuation therapy.

Time frame: Time of response to PD [up to 9 cycles (28-day cycles)]

Population: Participants with confirmed response (CR or PR). Only 1 participant in MF group had confirmed PR.

EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (1 (no problem), 2 (some problems), and 3 (extreme problems)). These combinations of attributes were converted into a single summary health-state index score by applying weights from the US-specific value set to the scoring algorithm. The EQ-5D US value set of health state index scores ranged from 0 (worst imagined health state) to 1 (best imagined health state).

Time frame: Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reported

Population: Enrolled participants who had a baseline and at least 1 post-baseline EQ-5D observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary.

Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality, deaths during the study including 30 days after treatment discontinuation. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module.

Time frame: Baseline to study completion [up to 9 cycles (28-day cycles)] plus 30-day safety follow-up

Population: Participants who received at least 1 dose of study drug.

Participants assessed their present level of itch through the use of an 11-point numeric rating scale anchored at 0 (no itch) and 10 (itch as bad as can be imagined).

Time frame: Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reported

Population: Enrolled participants who had a baseline and at least 1 post-baseline pruritus assessment observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary.

Elapsed time from date of study enrollment (baseline) to first evidence of Complete Response (CR) or Partial Response (PR) as per mSWAT for Mycosis Fungoides (MF) group; mSWAT and Sezary count for Sezary Syndrome (SS) group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks. PR: ≥50% mSWAT score reduction from baseline). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline). Response must be confirmed, but the time to objective response ended at the first assessment. Participants who were not confirmed responders did not contribute to the time to objective response calculation.

Time frame: Baseline to confirmed response [up to 9 cycles (28-day cycles)]

Population: Participants with confirmed response (CR or PR). Only 1 participant in MF group had confirmed PR.

Elapsed time from enrollment (baseline) to date of Progressive Disease (PD) as per mSWAT for Mycosis Fungoides (MF) group; mSWAT and Sezary count for Sezary Syndrome (SS) group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed to responses. PD: ≥25% of mSWAT score from nadir. Sezary cells percentage in lymphocytes measured using flow cytometry. PD: ≥40% Sezary cells from nadir. Responders or those who died without PD were censored at the date of the last progression-free disease assessment. Responders who received subsequent systemic anticancer therapy were censored at the date of the last progression-free disease assessment prior to post-discontinuation therapy.

Time frame: Baseline to measured PD [up to 9 cycles (28-day cycles)]

Population: All participants who received at least 1 dose of study drug. Ten (10) participants were censored for MF group and 2 participants were censored for SS group for this analysis.