Trial Outcomes & Findings for A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy (NCT NCT04995419)
NCT ID: NCT04995419
Last Updated: 2025-10-07
Results Overview
ORR was defined as the percentage of participants with best overall response (BOR) as complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.
COMPLETED
PHASE2
40 participants
From first dose up to progressive disease or death (maximum duration: 9.33 months)
2025-10-07
Participant Flow
Adult Chinese participants with locally advanced or metastatic urothelial cancer (mUC) who had received a platinum-containing chemotherapy and programmed cell death protein-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.
Participants who met inclusion criteria and none of the exclusion criteria were enrolled.
Participant milestones
| Measure |
Enfortumab Vedotin 1.25 mg/kg
Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Enfortumab Vedotin 1.25 mg/kg
Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Progressive Disease
|
19
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Ongoing
|
16
|
Baseline Characteristics
A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy
Baseline characteristics by cohort
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose up to progressive disease or death (maximum duration: 9.33 months)Population: FAS population
ORR was defined as the percentage of participants with best overall response (BOR) as complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors V1.1 (RECIST V1.1)
|
37.5 percentage of participants
Interval 22.7 to 54.2
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days)Population: Pharmacokinetic Analysis Set (PKAS) included all participants in the PK cohort who had received at least 3 of 4 doses up through Cycle 2 Day 1, and had at least 5 blood samples collected and assayed for measurement of ADC, TAb or unconjugated MMAE serum/plasma concentrations to determine at least 1 PK parameter.
Cmax was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=13 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1
ADC
|
28.1 micrograms per milliliter (ug/mL)
Standard Deviation 4.52
|
|
Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1
TAb
|
31.7 micrograms per milliliter (ug/mL)
Standard Deviation 5.73
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population.
Cmax was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=13 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
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|---|---|
|
PK of Monomethyl Auristatin E (MMAE) in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1
|
3.33 nanograms per milliliter (ng/mL)
Standard Deviation 1.74
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
Cmax was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
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|---|---|
|
PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15
ADC
|
27.6 ug/mL
Standard Deviation 4.01
|
|
PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15
TAb
|
34.4 ug/mL
Standard Deviation 4.64
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
Cmax was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of MMAE in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15
|
4.49 ng/mL
Standard Deviation 3.58
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-dosePopulation: PKAS population.
As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=13 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
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|---|---|
|
PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1
ADC
|
0 ug/mL
Standard Deviation NA
Standard Deviation was not reported in summary statistics because more than 50% of ADC concentrations at pre-dose were 0.
|
|
PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1
TAb
|
0 ug/mL
Standard Deviation NA
Standard Deviation was not reported in summary statistics because more than 50% of TAb concentrations at pre-dose were 0.
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-dosePopulation: PKAS population.
As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=13 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1
|
0 ng/mL
Standard Deviation NA
Standard Deviation was not reported in summary statistics because more than 50% of MMAE concentrations at pre-dose were 0.
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dosePopulation: PKAS population with available data were analyzed.
Ctrough was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=12 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15
ADC
|
1020 ug/mL
Standard Deviation 410
|
|
PK of ADC, TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15
TAb
|
4620 ug/mL
Standard Deviation 1590
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dosePopulation: PKAS population with available data were analyzed.
Ctrough was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=12 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15
|
1880 picograms per milliliter (pg/mL)
Standard Deviation 1680
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population.
Tmax was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=13 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1
ADC
|
0.0340 days
Interval 0.0278 to 0.0917
|
|
PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1
TAb
|
0.0340 days
Interval 0.0243 to 1.89
|
|
PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1
MMAE
|
2.00 days
Interval 1.87 to 2.93
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
Tmax was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 15
ADC
|
0.0337 days
Interval 0.0257 to 0.0805
|
|
PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 15
TAb
|
0.0337 days
Interval 0.0278 to 0.0854
|
|
PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 15
MMAE
|
1.93 days
Interval 0.858 to 2.92
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: Per protocol, data for AUC0-28d was planned to be calculated using non-compartment analysis (NCA) only if data permits, therefore AUC 0-28d was removed from the planned analysis in SAP.
AUC0-28d was derived from the PK blood samples collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: Per protocol, data for AUC0-28d was planned to be calculated using non-compartment analysis (NCA) only if data permits, therefore AUC 0-28d was removed from the planned analysis in SAP.
AUC0-28d was derived from the PK blood samples collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Cycle 1 Day 1 : pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
AUC0-7d was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=12 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 1
ADC
|
32.4 day*ug/mL
Standard Deviation 6.24
|
|
PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 1
TAb
|
77.4 day*ug/mL
Standard Deviation 17.3
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 : pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
AUC0-7d was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=12 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 1
|
16.9 day*ng/mL
Standard Deviation 9.21
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
AUC0-7d was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 15
ADC
|
36.5 day*ug/mL
Standard Deviation 7.93
|
|
PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 15
TAb
|
94.7 day*ug/mL
Standard Deviation 15.7
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
AUC0-7d was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 15
|
23.3 day*ng/mL
Standard Deviation 16.4
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
Accumulation ratio is the ratio of Cmax after the dosing interval (Cycle 1 Day 15) divided by Cmax after the first dosing interval (Cycle 1 Day 1).
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb, MMAE in Plasma: Accumulation Ratio of Cmax (RacCmax)
ADC
|
1.03 ratio
Standard Deviation 0.150
|
|
PK of ADC, TAb, MMAE in Plasma: Accumulation Ratio of Cmax (RacCmax)
TAb
|
1.13 ratio
Standard Deviation 0.137
|
|
PK of ADC, TAb, MMAE in Plasma: Accumulation Ratio of Cmax (RacCmax)
MMAE
|
1.28 ratio
Standard Deviation 0.499
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
RacAUC0-7d was calculated using AUC0-7d and derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb, MMAE in Serum: Accumulation Ratio of AUC0-7d ( RacAUC0-7d)
ADC
|
1.20 ratio
Standard Deviation 0.228
|
|
PK of ADC, TAb, MMAE in Serum: Accumulation Ratio of AUC0-7d ( RacAUC0-7d)
TAb
|
1.29 ratio
Standard Deviation 0.208
|
|
PK of ADC, TAb, MMAE in Serum: Accumulation Ratio of AUC0-7d ( RacAUC0-7d)
MMAE
|
1.32 ratio
Standard Deviation 0.486
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
t1/2 was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb, MMAE in Serum: Terminal Elimination Half-life (t1/2)
ADC
|
2.81 days
Interval 2.28 to 3.7
|
|
PK of ADC, TAb, MMAE in Serum: Terminal Elimination Half-life (t1/2)
TAb
|
3.82 days
Interval 3.11 to 5.49
|
|
PK of ADC, TAb, MMAE in Serum: Terminal Elimination Half-life (t1/2)
MMAE
|
3.12 days
Interval 2.83 to 3.82
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
CL was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb, MMAE in Serum: Systemic Clearance (CL)
ADC
|
0.104 Liters/hour (L/hr)
Standard Deviation 0.0239
|
|
PK of ADC, TAb, MMAE in Serum: Systemic Clearance (CL)
TAb
|
0.0396 Liters/hour (L/hr)
Standard Deviation 0.00847
|
|
PK of ADC, TAb, MMAE in Serum: Systemic Clearance (CL)
MMAE
|
196 Liters/hour (L/hr)
Standard Deviation 76.2
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)Population: PKAS population with available data were analyzed.
Vss was derived from the PK blood samples collected.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=10 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
PK of ADC, TAb, MMAE in Serum: Volume of Distribution at Steady State (Vss)
ADC
|
7.13 Liters
Standard Deviation 1.39
|
|
PK of ADC, TAb, MMAE in Serum: Volume of Distribution at Steady State (Vss)
TAb
|
4.97 Liters
Standard Deviation 1.27
|
|
PK of ADC, TAb, MMAE in Serum: Volume of Distribution at Steady State (Vss)
MMAE
|
28900 Liters
Standard Deviation 10800
|
SECONDARY outcome
Timeframe: From date of the first CR/PR up to progressive disease or death (maximum duration: 9.33 months)Population: FAS population with available data were analyzed.
DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by IRC to the date of documented progressive disease. or death due to any cause whichever occurred first. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. Progressive Disease:\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \>= 5 mm. Appearance of 1 or more new lesions is also considered progression.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=15 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Duration of Response (DOR) as Per RECIST V1.1 Per IRC
|
NA months
Interval 2.04 to
Due to low number of events, median and upper limit of CI was not estimable.
|
SECONDARY outcome
Timeframe: From date of the first CR/PR up to progressive disease or death (maximum duration: 9.33 months)Population: FAS population with available data were analyzed.
DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by Investigator's Assesment to the date of documented progressive disease or death due to any cause whichever occurred first. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. Progressive disease:\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \>= 5 mm. Appearance of 1 or more new lesions is also considered progression.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=17 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Duration of Response (DOR) as Per RECIST V1.1 Per Investigator's Assessment
|
NA months
Interval 2.04 to
Due to low number of events, median and upper limit of CI was not estimable.
|
SECONDARY outcome
Timeframe: From first dose up to progressive disease or death (maximum duration: 9.33 months)Population: FAS population
ORR was defined as the percentage of participants with BOR as CR or PR based on the RECIST v1.1 as per investigator's assesment. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Objective Response Rate (ORR) as Per Investigator Assessment
|
42.5 percentage of participants
Interval 27.0 to 59.1
|
SECONDARY outcome
Timeframe: From first dose up to progressive disease or death (maximum duration: 9.33 months)Population: FAS population.
DCR: percentage of participants with a CR, PR or SD based on RECIST v1.1 as assessed by IRC. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease:\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \>= 5 mm. Appearance of 1 or more new lesions is also considered progression.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Disease Control Rate (DCR) as Per RECIST V1.1 Per IRC
|
72.5 percentage of participants
Interval 56.1 to 85.4
|
SECONDARY outcome
Timeframe: From first dose up to progressive disease or death (maximum duration: 9.33 months)Population: FAS population.
DCR: percentage of participants with a CR, PR or SD based on RECIST v1.1 as assessed by investigator's assessment. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease:\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \>= 5 mm. Appearance of 1 or more new lesions is also considered progression.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Disease Control Rate (DCR) as Per RECIST V1.1 Per Investigator's Assesment
|
82.5 percentage of participants
Interval 67.2 to 92.7
|
SECONDARY outcome
Timeframe: From first dose up to progressive disease or death (maximum duration: 9.33 months)Population: FAS population
PFS: time from first dose of the study drug until date of documented radiological disease progression per IRC based on RECIST V1.1, or until death due to any cause, whichever occurred first. Progressive disease: \>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \>= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last radiological assessment (RA)/ date of randomization if no post-baseline RA was available. Participants who received any further anticancer therapy (ACT) for disease before radiological progression was censored at date of last RA before ACT started and participants who had PD/death after \>=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Progression Free-Survival Per RECIST V1.1 Per IRC
|
4.67 months
Interval 3.65 to 5.62
|
SECONDARY outcome
Timeframe: From first dose up to progressive disease or death (maximum duration: 9.33 months)Population: FAS population
PFS: time from first dose of the study drug until date of documented radiological disease progression per investigator based on RECIST V1.1, or until death due to any cause, whichever occurred first. Progressive disease: \>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \>= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last RA/ date of randomization if no post-baseline RA was available. Participants who received any further ACT for disease before radiological progression was censored at date of last RA before ACT started and participants who had progressive disease/death after \>=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Progression Free-Survival Per RECIST V1.1 Per Investigator's Assessment
|
4.24 months
Interval 3.75 to 7.2
|
SECONDARY outcome
Timeframe: From first dose up to death (maximum duration: 9.33 months)Population: FAS population
OS was defined as the time from first dose of the study drug until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 6.74 to
Due to low number of events, median and upper limit of CI was not estimable.
|
SECONDARY outcome
Timeframe: From first dose until 9.33 monthsPopulation: FAS population with available data were analyzed.
Number of participants with ATA were reported.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=38 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
Baseline Positive, Positive post-baseline
|
0 Participants
|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
Baseline Negative, Negative post-baseline
|
37 Participants
|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
Baseline Negative, Positive post-baseline
|
0 Participants
|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
Baseline Positive, Negative post-baseline
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 9.33 monthsPopulation: Safety analysis set (SAF) included all participants who were enrolled and received any amount of study drug in the study.
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE is defined as an adverse event observed after starting administration of the study drug and within 30 days after taking the last dose of study drug.
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
40 Participants
|
SECONDARY outcome
Timeframe: End of Treatment (Baseline up to 9.33 months)Population: SAF population
ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead. Number of participants with ECOG PS was reported."
Outcome measures
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 Participants
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS= 0
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS= 1
|
8 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS= 2
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS= 3
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS= 4
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS= 5
|
0 Participants
|
Adverse Events
Enfortumab Vedotin 1.25 mg/kg
Serious adverse events
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 participants at risk
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
2/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Cardiac disorders
Acute coronary syndrome
|
2.5%
1/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Eye disorders
Cataract
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
General disorders
Chest pain
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Febrile infection
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Pneumonia
|
12.5%
5/40 • Number of events 6 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Respiratory tract infection
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Investigations
Neutrophil count decreased
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.5%
1/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
1/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Psychiatric disorders
Confusional state
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.5%
1/40 • Number of events 1 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
2.5%
1/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
5.0%
2/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
3/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
1/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
Other adverse events
| Measure |
Enfortumab Vedotin 1.25 mg/kg
n=40 participants at risk
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
70.0%
28/40 • Number of events 81 • Baseline up to 9.33 months
SAF
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
4/40 • Number of events 6 • Baseline up to 9.33 months
SAF
|
|
Eye disorders
Dry eye
|
7.5%
3/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Eye disorders
Eye discharge
|
12.5%
5/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Eye disorders
Vision blurred
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
4/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
4/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
5/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Constipation
|
47.5%
19/40 • Number of events 25 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Diarrhoea
|
47.5%
19/40 • Number of events 31 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Dyspepsia
|
17.5%
7/40 • Number of events 10 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Dysphagia
|
15.0%
6/40 • Number of events 10 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
4/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Mouth ulceration
|
17.5%
7/40 • Number of events 7 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Nausea
|
50.0%
20/40 • Number of events 39 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
12/40 • Number of events 17 • Baseline up to 9.33 months
SAF
|
|
General disorders
Asthenia
|
10.0%
4/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
General disorders
Fatigue
|
25.0%
10/40 • Number of events 31 • Baseline up to 9.33 months
SAF
|
|
General disorders
Malaise
|
15.0%
6/40 • Number of events 7 • Baseline up to 9.33 months
SAF
|
|
General disorders
Oedema peripheral
|
17.5%
7/40 • Number of events 15 • Baseline up to 9.33 months
SAF
|
|
General disorders
Pyrexia
|
35.0%
14/40 • Number of events 17 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Herpes dermatitis
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Herpes virus infection
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Pneumonia
|
7.5%
3/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Skin infection
|
15.0%
6/40 • Number of events 8 • Baseline up to 9.33 months
SAF
|
|
Infections and infestations
Urinary tract infection
|
7.5%
3/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Investigations
Alanine aminotransferase increased
|
45.0%
18/40 • Number of events 30 • Baseline up to 9.33 months
SAF
|
|
Investigations
Aspartate aminotransferase increased
|
65.0%
26/40 • Number of events 43 • Baseline up to 9.33 months
SAF
|
|
Investigations
Bilirubin conjugated increased
|
5.0%
2/40 • Number of events 8 • Baseline up to 9.33 months
SAF
|
|
Investigations
Blood bilirubin increased
|
10.0%
4/40 • Number of events 18 • Baseline up to 9.33 months
SAF
|
|
Investigations
Blood bilirubin unconjugated increased
|
5.0%
2/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Investigations
Blood creatinine increased
|
12.5%
5/40 • Number of events 7 • Baseline up to 9.33 months
SAF
|
|
Investigations
Blood glucose increased
|
10.0%
4/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.0%
2/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Investigations
Blood triglycerides increased
|
5.0%
2/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.5%
3/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Investigations
Glycosylated haemoglobin increased
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Investigations
Lymphocyte count decreased
|
7.5%
3/40 • Number of events 6 • Baseline up to 9.33 months
SAF
|
|
Investigations
Neutrophil count decreased
|
47.5%
19/40 • Number of events 36 • Baseline up to 9.33 months
SAF
|
|
Investigations
Occult blood positive
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Investigations
Platelet count decreased
|
22.5%
9/40 • Number of events 22 • Baseline up to 9.33 months
SAF
|
|
Investigations
Weight decreased
|
25.0%
10/40 • Number of events 17 • Baseline up to 9.33 months
SAF
|
|
Investigations
White blood cell count decreased
|
40.0%
16/40 • Number of events 43 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Decreased appetite
|
65.0%
26/40 • Number of events 46 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
5/40 • Number of events 20 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
10.0%
4/40 • Number of events 6 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
20/40 • Number of events 57 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
15.0%
6/40 • Number of events 17 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
27.5%
11/40 • Number of events 24 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
10/40 • Number of events 22 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
8/40 • Number of events 22 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
12.5%
5/40 • Number of events 9 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
2/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
37.5%
15/40 • Number of events 28 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
32.5%
13/40 • Number of events 35 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
17.5%
7/40 • Number of events 14 • Baseline up to 9.33 months
SAF
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.0%
2/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
4/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
4/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Nervous system disorders
Dizziness
|
7.5%
3/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Nervous system disorders
Dysgeusia
|
25.0%
10/40 • Number of events 21 • Baseline up to 9.33 months
SAF
|
|
Nervous system disorders
Hypoaesthesia
|
15.0%
6/40 • Number of events 7 • Baseline up to 9.33 months
SAF
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
8/40 • Number of events 9 • Baseline up to 9.33 months
SAF
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Psychiatric disorders
Insomnia
|
20.0%
8/40 • Number of events 15 • Baseline up to 9.33 months
SAF
|
|
Renal and urinary disorders
Dysuria
|
7.5%
3/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Renal and urinary disorders
Haematuria
|
7.5%
3/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
8/40 • Number of events 12 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
10.0%
4/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
2/40 • Number of events 3 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
7.5%
3/40 • Number of events 4 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
4/40 • Number of events 6 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.0%
12/40 • Number of events 17 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
10.0%
4/40 • Number of events 8 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.5%
3/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Papule
|
12.5%
5/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
20.0%
8/40 • Number of events 8 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
35.0%
14/40 • Number of events 27 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.5%
17/40 • Number of events 56 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.0%
6/40 • Number of events 13 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
12.5%
5/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
7.5%
3/40 • Number of events 5 • Baseline up to 9.33 months
SAF
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • Number of events 2 • Baseline up to 9.33 months
SAF
|
Additional Information
Clinical Transparency
Astellas Pharma China, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER