Trial Outcomes & Findings for A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (NCT NCT01871727)

Last Updated: 2024-11-13

Results Overview

DLTs as per NCI CTCAE v4.03 were defined as 1) serious infusion reaction (CTCAE) Grade 4 adverse event of "Infusion related reaction," or recurrent CTCAE Grade 3 despite administration of systemic steroid premedication after initial occurrence. Infusion reactions were defined as symptoms (example, fatigue, nausea, vomiting, arthralgia, myalgia, pyrexia, chills, rigors) occurring within 24 hours of E7777 infusion. 2) Capillary leak syndrome (CLS) CTCAE Grade 4 or Grade 3 (with exceptions). A CLS event was defined as the noted occurrence of at least 2 of the following: hypotension, edema, or serum albumin less than (\<) 3.0 gram per decilitre (g/dL). 3) Clinical visual impairment. 4) Any CTCAE Grade greater than or equal to (\>=) 4 adverse event (AE) that may represent an infusion reaction. 5) Any other Grade 3 or greater toxicity assessed as related to E7777 treatment and which in the opinion of a safety consultancy investigator panel, was a dose-limiting toxicity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

Cycle 1 (cycle length was 21 days)

Results posted on

2024-11-13

Participant Flow

Participants took part in the study at 20 investigative sites in the United States and Australia from 30 May 2013 to 14 December 2021.

36 participants were screened in Lead-In Part, out of which 21 were enrolled and treated.143 participants were screened in Main Study Part, out of which 91 were enrolled and 90 were treated. As per planned analysis, data was collectively reported for total 98 participants (Full analysis set/Safety analysis set) from Main Study Part and Lead-In Part who received study drug at 9 micrograms per kilograms (mcg/kg) dose. 8 participants were from Lead-In Part and 90 were from Main Study Part.

Participant milestones

Participant milestones
Measure	Lead-In Part: E7777 6 mcg/kg Participants were treated with E7777 6 mcg/kg by intravenous (IV) infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Main Study Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Main study part.
Lead-In Part (1 Year 2 Months) STARTED	2	8	9	2	0
Lead-In Part (1 Year 2 Months) Primary Efficacy Analysis Set	0	5	0	0	0
Lead-In Part (1 Year 2 Months) COMPLETED	1	4	5	2	0
Lead-In Part (1 Year 2 Months) NOT COMPLETED	1	4	4	0	0
Main Study Part (2 Years 4 Months) STARTED	0	0	0	0	91
Main Study Part (2 Years 4 Months) Primary Efficacy Analysis Set	0	0	0	0	64
Main Study Part (2 Years 4 Months) COMPLETED	0	0	0	0	46
Main Study Part (2 Years 4 Months) NOT COMPLETED	0	0	0	0	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Lead-In Part: E7777 6 mcg/kg Participants were treated with E7777 6 mcg/kg by intravenous (IV) infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Main study part.
Lead-In Part (1 Year 2 Months) Disease Progression	1	4	4	0
Main Study Part (2 Years 4 Months) Other	0	0	0	2
Main Study Part (2 Years 4 Months) Sponsor Decision	0	0	0	11
Main Study Part (2 Years 4 Months) Withdrawal by Subject	0	0	0	9
Main Study Part (2 Years 4 Months) Disease progression	0	0	0	20
Main Study Part (2 Years 4 Months) Lost to Follow-up	0	0	0	2
Main Study Part (2 Years 4 Months) Not treated	0	0	0	1

Baseline Characteristics

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 12 mcg/kg n=9 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=2 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part and Main Study Part: E7777 9 mcg/kg n=98 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.	Total n=111 Participants Total of all reporting groups
Age, Continuous	54.0 years STANDARD_DEVIATION 22.63 • n=5 Participants	58.4 years STANDARD_DEVIATION 15.88 • n=7 Participants	69.0 years STANDARD_DEVIATION 2.83 • n=5 Participants	62.9 years STANDARD_DEVIATION 11.91 • n=4 Participants	62.5 years STANDARD_DEVIATION 12.32 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	37 Participants n=4 Participants	45 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	61 Participants n=4 Participants	66 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	14 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	81 Participants n=4 Participants	93 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	16 Participants n=4 Participants	20 Participants n=21 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	73 Participants n=4 Participants	82 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants

PRIMARY outcome

Timeframe: Cycle 1 (cycle length was 21 days)

Population: Lead-in analysis set included all participants enrolled in lead-in part.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=8 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=9 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=2 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03)	0 Participants	0 Participants	0 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Cycle 1 (cycle length was 21 days)

Population: Dose-finding analysis set included all participants in the Lead-in part who completed Cycle 1 treatment and were evaluated for DLT, and those who discontinued during Cycle 1 due to DLT.

The MTD was defined as the safe dose level established in Lead-In Part. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the Lead-In Part.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=21 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Maximum Tolerated Dose (MTD) of E7777	12.0 mcg/kg	—	—	—	—

PRIMARY outcome

Timeframe: From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)

Population: Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose

ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review committee on 2 assessments at least 3 weeks apart. The tumor response was based on global response score (GRS) Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=69 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Objective Response Rate (ORR) by Independent Review Committee (IRC) Based on Olsen 2011 Criteria	36.2 percentage of participants Interval 25.0 to 48.7	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 1 year 2 months)

Population: Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead in part.

DOR per investigator assessment was defined as the time from date when criteria for response (CR or PR) was first met until the date of the first documentation of disease progression (PD) or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=1 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=4 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=3 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Duration of Response (DOR) Per Investigator Assessment	43.0 days Interval 43.0 to 43.0	106.0 days Interval 71.0 to 134.0	113.0 days Interval 92.0 to 351.0	—	—

SECONDARY outcome

Timeframe: From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 3 years 6 months)

Population: Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here, 'overall number of participants analyzed' were those who had CR or PR in Lead-in part and in Main study part.

DOR per independent review committee was defined as the time from the date when criteria for response (CR or PR) was first met until the date of the first documentation of PD or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=25 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Duration of Response (DOR) Per Independent Review Committee	6.47 months Interval 3.0 to 23.5	—	—	—	—

SECONDARY outcome

Timeframe: From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 1 year 2 months)

Population: Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead-in part of the study.

Time to response per investigator assessment was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=1 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=4 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=3 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Time to Response (TTR) Per Investigator Assessment	106.0 days Interval 106.0 to 106.0	53.5 days Interval 22.0 to 85.0	64.0 days Interval 57.0 to 106.0	—	—

SECONDARY outcome

Timeframe: From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 3 years 6 months)

Time to response per independent review committee was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=25 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Time to Response (TTR) Per Independent Review Committee	1.41 months Interval 0.7 to 5.6	—	—	—	—

SECONDARY outcome

Timeframe: From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)

Population: Lead-in analysis set included all participants enrolled in the lead-in part and Investigator efficacy analysis set included all Stage I to III participants (both Main Study \[n=66\] and Lead-In \[n=5\]) who received study drug at 9 mcg/kg dose.

ORR per investigator assessment was defined as the percentage of participants whose BOR was CR or PR. The tumor response was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=8 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=9 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=2 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg n=71 Participants Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part and Main Study Part: ORR Per Investigator Assessment	50.0 percentage of participants Interval 1.3 to 98.7	50.0 percentage of participants Interval 15.7 to 84.3	33.3 percentage of participants Interval 7.5 to 70.1	0 percentage of participants Interval 0.0 to 84.2	42.3 percentage of participants Interval 30.6 to 54.6

SECONDARY outcome

Timeframe: From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)

Population: Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose.

ORR was defined as the percentage of participants whose BOR was CR, clinical complete response (CCR) or PR per IRC. The tumor response was based on Prince 2010 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. CCR was defined as tumor residue not visible on esophagogram, computed tomography (CT), endoscopy, positron emission tomography (PET)-CT.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=69 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: ORR Per IRC Based on Prince 2010 Criteria	36.2 percentage of participants Interval 25.0 to 48.7	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months)

Population: Lead-In Part: SAS included all participants who received study drug. Main Study Part: SAS included all participants (both Main Study and Lead-In) who received study drug at 9 mcg/kg.

TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=9 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=2 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=98 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part and Main Study Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	2 Participants	9 Participants	2 Participants	97 Participants	—
Lead-In Part and Main Study Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	4 Participants	2 Participants	36 Participants	—

SECONDARY outcome

Timeframe: Cycles 1, 3, 5 Day 1: Pre-dose up to 300 minutes post-dose (Cycle length was 21 days)

Population: Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints.

Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no Pharmacokinetic (PK) data was collected and analyzed for these doses and cycles.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=7 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=8 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=2 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Maximum Serum Concentration (Cmax) of E7777 Cycle 1 Day 1	135 nanogram per milliliter (ng/mL) Standard Deviation 26.2	118 nanogram per milliliter (ng/mL) Standard Deviation 70.8	183 nanogram per milliliter (ng/mL) Standard Deviation 65.3	383 nanogram per milliliter (ng/mL) Standard Deviation 133	—
Lead-In Part: Maximum Serum Concentration (Cmax) of E7777 Cycle 3 Day 1	59.5 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—	—	—
Lead-In Part: Maximum Serum Concentration (Cmax) of E7777 Cycle 5 Day 1	—	—	105 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 minutes post-dose (Cycle length was 21 days)

Population: Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given timepoints.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=20 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Maximum Serum Concentration (Cmax) of E7777 Cycle 1 Day 1	114 ng/mL Standard Deviation 62.5	—	—	—	—
Main Study Part: Maximum Serum Concentration (Cmax) of E7777 Cycle 3 Day 1	37.5 ng/mL Standard Deviation 19.4	—	—	—	—
Main Study Part: Maximum Serum Concentration (Cmax) of E7777 Cycle 5 Day 1	45.5 ng/mL Standard Deviation 46.8	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours Post-dose (Cycle length was 21 days)

Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. Here, min\*ng/mL means minute\*nanogram per milliliter.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=7 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=8 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=2 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777 Cycle 1 Day 1	18500 min*ng/mL Standard Deviation 6080	18200 min*ng/mL Standard Deviation 13100	23600 min*ng/mL Standard Deviation 12900	39800 min*ng/mL Standard Deviation 4170	—
Lead-In Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777 Cycle 3 Day 1	4670 min*ng/mL Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—	—	—
Lead-In Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777 Cycle 5 Day 1	—	—	6730 min*ng/mL Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=20 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777 Cycle 1 Day 1	16300 min*ng/mL Standard Deviation 12600	—	—	—	—
Main Study Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777 Cycle 3 Day 1	2170 min*ng/mL Standard Deviation 974	—	—	—	—
Main Study Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777 Cycle 5 Day 1	2660 min*ng/mL Standard Deviation 2570	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=4 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=5 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=1 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777 Cycle 1 Day 1	20600 min*ng/mL Standard Deviation 7850	27000 min*ng/mL Standard Deviation 16500	30000 min*ng/mL Standard Deviation 12900	43500 min*ng/mL Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—
Lead-In Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777 Cycle 3 Day 1	4960 min*ng/mL Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—	—	—
Lead-In Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777 Cycle 5 Day 1	—	—	6900 min*ng/mL Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=10 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777 Cycle 1 Day 1	23700 min*ng/mL Standard Deviation 12700	—	—	—	—
Main Study Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777 Cycle 5 Day 1	4630 min*ng/mL Standard Deviation NA Standard deviation could not be estimated for Cycle 5 Day 1 as insufficient number of participants were available for analysis.	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=4 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=5 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=2 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Terminal Elimination Half-life (t1/2) of E7777 Cycle 1 Day 1	92.0 minutes Interval 74.5 to 109.0	116 minutes Interval 55.9 to 138.0	100 minutes Interval 47.9 to 120.0	100 minutes Interval 71.5 to 129.0	—
Lead-In Part: Terminal Elimination Half-life (t1/2) of E7777 Cycle 3 Day 1	39.6 minutes Interval 39.6 to 39.6	—	—	—	—
Lead-In Part: Terminal Elimination Half-life (t1/2) of E7777 Cycle 5 Day 1	—	—	20.5 minutes Interval 20.5 to 20.5	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=12 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Terminal Elimination Half-life (t1/2) of E7777 Cycle 1 Day 1	109 minutes Interval 58.9 to 168.0	—	—	—	—
Main Study Part: Terminal Elimination Half-life (t1/2) of E7777 Cycle 3 Day 1	90.8 minutes Interval 90.8 to 90.8	—	—	—	—
Main Study Part: Terminal Elimination Half-life (t1/2) of E7777 Cycle 5 Day 1	51.7 minutes Interval 51.7 to 51.7	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=7 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=8 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=2 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax) Cycle 1 Day 1	75 minute Interval 60.0 to 90.0	60 minute Interval 30.0 to 180.0	61.5 minute Interval 49.2 to 90.0	60 minute Interval 60.0 to 60.0	—
Lead-In Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax) Cycle 3 Day 1	60 minute Interval 60.0 to 60.0	—	—	—	—
Lead-In Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax) Cycle 5 Day 1	—	—	60 minute Interval 60.0 to 60.0	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=20 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax) Cycle 1 Day 1	60 minutes Interval 28.0 to 180.0	—	—	—	—
Main Study Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax) Cycle 3 Day 1	60 minutes Interval 30.0 to 74.0	—	—	—	—
Main Study Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax) Cycle 5 Day 1	60 minutes Interval 30.0 to 64.0	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=4 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=5 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=1 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Total Body Clearance (CL) of E7777 Cycle 1 Day 1	0.316 mL/min/kg Standard Deviation 0.12	0.492 mL/min/kg Standard Deviation 0.38	0.551 mL/min/kg Standard Deviation 0.48	0.359 mL/min/kg Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—
Lead-In Part: Total Body Clearance (CL) of E7777 Cycle 3 Day 1	1.21 mL/min/kg Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—	—	—
Lead-In Part: Total Body Clearance (CL) of E7777 Cycle 5 Day 1	—	—	1.80 mL/min/kg Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=10 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Total Body Clearance (CL) of E7777 Cycle 1 Day 1	44.6 mL/min/kg Standard Deviation 32.6	—	—	—	—
Main Study Part: Total Body Clearance (CL) of E7777 Cycle 5 Day 1	133 mL/min/kg Standard Deviation NA Standard deviation could not be estimated for Cycle 5 Day 1 as insufficient number of participants were available for analysis.	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=4 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=5 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=1 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Volume of Distribution at Steady State (Vdss) of E7777 Cycle 1 Day 1	39.8 milliliter per kilogram (mL/kg) Standard Deviation 4.81	60.3 milliliter per kilogram (mL/kg) Standard Deviation 19.50	61 milliliter per kilogram (mL/kg) Standard Deviation 21.80	37 milliliter per kilogram (mL/kg) Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—
Lead-In Part: Volume of Distribution at Steady State (Vdss) of E7777 Cycle 3 Day 1	69.1 milliliter per kilogram (mL/kg) Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—	—	—
Lead-In Part: Volume of Distribution at Steady State (Vdss) of E7777 Cycle 5 Day 1	—	—	53.3 milliliter per kilogram (mL/kg) Standard Deviation NA Standard deviation could not be estimated as insufficient number of participants were available for analysis.	—	—

SECONDARY outcome

Timeframe: Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=20 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Volume of Distribution at Steady State (Vdss) of E7777 Cycle 1 Day 1	5430 milliliter (mL) Standard Deviation 2210	—	—	—	—
Main Study Part: Volume of Distribution at Steady State (Vdss) of E7777 Cycle 5 Day 1	10700 milliliter (mL) Standard Deviation NA Standard deviation could not be estimated for Cycle 5 Day 1 as insufficient number of participants were available for analysis.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1

Population: Lead-in PK Analysis Set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained.

Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=2 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg n=8 Participants Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg n=9 Participants Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg n=2 Participants Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies Cycle 1 Day 1 (Anti-E7777 Antibodies)	50.0 percentage of participants	100.0 percentage of participants	88.9 percentage of participants	100.0 percentage of participants	—
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies Cycle 2 Day 1 (Anti-E7777 Antibodies)	100.0 percentage of participants	100.0 percentage of participants	83.3 percentage of participants	0 percentage of participants	—
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies Cycle 3 Day 1 (Anti-E7777 Antibodies)	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	0 percentage of participants	—
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies Cycle 5 Day 1 (Anti-E7777 Antibodies)	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	0 percentage of participants	—
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies Cycle 1 Day 1 (Anti-IL-2 Antibodies)	0 percentage of participants	37.5 percentage of participants	33.3 percentage of participants	0 percentage of participants	—
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies Cycle 2 Day 1 (Anti-IL-2 Antibodies)	0 percentage of participants	87.5 percentage of participants	83.3 percentage of participants	0 percentage of participants	—
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies Cycle 3 Day 1 (Anti-IL-2 Antibodies)	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	0 percentage of participants	—
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies Cycle 5 Day 1 (Anti-IL-2 Antibodies)	100.0 percentage of participants	83.3 percentage of participants	100.0 percentage of participants	0 percentage of participants	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1

Population: Main Study Part PK Analysis Set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In).

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=94 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies Cycle 1 Day 1 (Anti-E7777 Antibodies)	85.7 percentage of participants	—	—	—	—
Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies Cycle 2 Day 1 (Anti-E7777 Antibodies)	91.7 percentage of participants	—	—	—	—
Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies Cycle 3 Day 1 (Anti-E7777 Antibodies)	95.7 percentage of participants	—	—	—	—
Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies Cycle 1 Day 1 (Anti-IL-2 Antibodies)	5.5 percentage of participants	—	—	—	—
Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies Cycle 2 Day 1 (Anti-IL-2 Antibodies)	52.3 percentage of participants	—	—	—	—
Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies Cycle 3 Day 1 (Anti-IL-2 Antibodies)	88.6 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 30 months

Population: Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose.

Modified severity weighted assessment tool (mSWAT) was used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=69 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Number of Participants With Objective Skin Response	25 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 30 months

Population: Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here 'overall number of participants analyzed' were those who had a skin response.

The duration of skin response based on the mSWAT score was defined as time from the date when criteria for skin response (CR or PR) was first met until the date of documented PD or death due to any cause for those participants with a confirmed PR or CR. mSWAT was used to measure skin disease severity based on the percentage of BSA with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=25 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Duration of Skin Response	6.47 months Interval 3.0 to 23.5	—	—	—	—

SECONDARY outcome

Timeframe: Up to 30 months

Population: Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here 'overall number of participants analyzed' were those who had a skin response.

The time to skin response based on the mSWAT score was defined as time from the date of first dose to the date when criteria for skin response (CR or PR) were first met. mSWAT was used to measure skin disease severity based on the percentage of BSA with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.

Outcome measures

Outcome measures
Measure	Lead-In Part: E7777 6 mcg/kg n=25 Participants Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 9 mcg/kg Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.	Lead-In Part: E7777 12 mcg/kg Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Lead-In Part: E7777 15 mcg/kg Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.	Main Study Part: E7777 9 mcg/kg Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Main Study Part: Time to Skin Response	1.41 months Interval 0.7 to 5.6	—	—	—	—

Adverse Events

Lead-In Part: E7777 6 mcg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Lead-In Part: E7777 12 mcg/kg

Serious events: 4 serious events

Other events: 9 other events

Deaths: 3 deaths

Lead-In Part: E7777 15 mcg/kg

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Lead-In Part and Main Study Part: E7777 9 mcg/kg

Serious events: 36 serious events

Other events: 95 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place