Trial Outcomes & Findings for Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) (NCT NCT04003610)

Last Updated: 2025-11-04

Results Overview

PFS was defined as the time from the randomization date until the date of disease progression (as measured by a blinded independent central review \[BICR\] per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) or death due to any cause, whichever occurred first.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

up to 130 days

Results posted on

2025-11-04

Participant Flow

This study was conducted (enrolled participants) at 7 sites located in France, Italy, Spain, and Japan.

Participant milestones

Participant milestones
Measure	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Overall Study STARTED	1	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Overall Study Lost to Follow-up	1	0
Overall Study Death	0	3
Overall Study Study Terminated by Sponsor	0	3

Baseline Characteristics

Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=6 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Total n=7 Participants Total of all reporting groups
Age, Customized 57 to 84 years old	0 Participants n=15 Participants	1 Participants n=161 Participants	6 Participants n=100 Participants	7 Participants n=3 Participants
Sex: Female, Male Female	—	NA Participants n=161 Participants	4 Participants n=100 Participants	NA Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	NA Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	NA Participants n=161 Participants	5 Participants n=100 Participants	NA Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	NA Participants n=161 Participants	1 Participants n=100 Participants	NA Participants n=3 Participants
Sex: Female, Male Male	—	NA Participants n=161 Participants	2 Participants n=100 Participants	NA Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	NA Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants
Race (NIH/OMB) Asian	—	NA Participants n=161 Participants	3 Participants n=100 Participants	NA Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	NA Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants
Race (NIH/OMB) Black or African American	—	NA Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants
Race (NIH/OMB) White	—	NA Participants n=161 Participants	3 Participants n=100 Participants	NA Participants n=3 Participants
Race (NIH/OMB) More than one race	—	NA Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	—	NA Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants

PRIMARY outcome

Timeframe: up to 130 days

Population: Intent-to-Treat (ITT) Population: all participants who were randomized into the study. Treatment groups for this population were to be determined according to the treatment assignment at the time of randomization. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.

Outcome measures

Outcome measures
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=6 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Progression-free Survival (PFS)	—	1.81 months The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.	2.12 months Interval 1.51 to The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 225 days

Population: ITT Population. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.

OS was defined as the time from the date of randomization until death due to any cause.

Outcome measures

Outcome measures
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=6 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Overall Survival (OS)	—	NA months The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.	NA months Interval 1.51 to The median and the upper limit of the confidence interval were not estimable because too few participants died.

SECONDARY outcome

Timeframe: up to 148 days

ORR was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 (as measured by BICR).

Outcome measures

Outcome measures
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=6 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Objective Response Rate (ORR)	—	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: up to 148 days

Population: As measured by BICR, there were no responders; thus, DOR was not calculated.

DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression (per RECIST v1.1) or death, whichever occurred first (as measured by BICR).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 178 days

Population: Safety Population: all randomized participants who received at least one dose of study treatment. Treatment groups for this population were to be determined according to the actual treatment the participant received regardless of assigned study drug treatment.

A treatment-emergent adverse event was defined as an adverse event that was either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=6 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Number of Participants With Treatment-emergent Adverse Events	—	1 Participants	6 Participants

SECONDARY outcome

Timeframe: up to 160 days

Population: ITT Population. Only participants with available data were analyzed.

The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual.

Outcome measures

Outcome measures
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=5 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
EORTC QLQ-C30 Score Dyspnea, Cycle 6 Day 1	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Emotional Functioning, Baseline	—	50.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	73.3 scores on a scale Standard Deviation 19.00
EORTC QLQ-C30 Score Pain, Follow Up	—	—	16.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Role Functioning, Follow Up	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Appetite Loss, Baseline	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	26.7 scores on a scale Standard Deviation 36.51
EORTC QLQ-C30 Score Appetite Loss, Cycle 3 Day 1	—	—	16.7 scores on a scale Standard Deviation 23.57
EORTC QLQ-C30 Score Appetite Loss, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Appetite Loss, Follow Up	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Cognitive Functioning, Baseline	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	66.7 scores on a scale Standard Deviation 20.41
EORTC QLQ-C30 Score Cognitive Functioning, Cycle 3 Day 1	—	—	91.7 scores on a scale Standard Deviation 11.79
EORTC QLQ-C30 Score Cognitive Functioning, Cycle 6 Day 1	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Cognitive Functioning, Follow Up	—	—	83.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Constipation, Baseline	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	40.0 scores on a scale Standard Deviation 27.89
EORTC QLQ-C30 Score Constipation, Cycle 3 Day 1	—	—	16.7 scores on a scale Standard Deviation 23.57
EORTC QLQ-C30 Score Constipation, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Constipation, Follow Up	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Diarrhea, Baseline	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	20.0 scores on a scale Standard Deviation 44.72
EORTC QLQ-C30 Score Diarrhea, Cycle 3 Day 1	—	—	0.0 scores on a scale Standard Deviation 0.0
EORTC QLQ-C30 Score Diarrhea, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Diarrhea, Follow Up	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Dyspnea, Baseline	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	26.7 scores on a scale Standard Deviation 27.89
EORTC QLQ-C30 Score Dyspnea, Cycle 3 Day 1	—	—	16.7 scores on a scale Standard Deviation 23.57
EORTC QLQ-C30 Score Dyspnea, Follow Up	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Emotional Functioning, Cycle 3 Day 1	—	—	87.5 scores on a scale Standard Deviation 5.89
EORTC QLQ-C30 Score Emotional Functioning, Cycle 6 Day 1	—	—	91.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Emotional Functioning, Follow Up	—	—	100.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Fatigue, Baseline	—	44.4 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	46.7 scores on a scale Standard Deviation 36.35
EORTC QLQ-C30 Score Fatigue, Cycle 3 Day 1	—	—	50.0 scores on a scale Standard Deviation 39.28
EORTC QLQ-C30 Score Fatigue, Cycle 6 Day 1	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Fatigue, Follow Up	—	—	55.6 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Financial Difficulties, Baseline	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	20.0 scores on a scale Standard Deviation 18.26
EORTC QLQ-C30 Score Financial Difficulties, Cycle 3 Day 1	—	—	16.7 scores on a scale Standard Deviation 23.57
EORTC QLQ-C30 Score Financial Difficulties, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Financial Difficulties, Follow Up	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Global Health Status/Quality of Life (QoL), Baseline	—	16.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	51.7 scores on a scale Standard Deviation 31.95
EORTC QLQ-C30 Score Global Health Status/QoL, Cycle 3 Day 1	—	—	66.7 scores on a scale Standard Deviation 11.79
EORTC QLQ-C30 Score Global Health Status/QoL, Cycle 6 Day 1	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Global Health Status/QoL, Follow Up	—	—	50.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Insomnia, Baseline	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	46.7 scores on a scale Standard Deviation 38.01
EORTC QLQ-C30 Score Insomnia, Cycle 3 Day 1	—	—	33.3 scores on a scale Standard Deviation 47.14
EORTC QLQ-C30 Score Insomnia, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Insomnia, Follow Up	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Nausea and Vomiting, Baseline	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	6.7 scores on a scale Standard Deviation 9.13
EORTC QLQ-C30 Score Nausea and Vomiting, Cycle 3 Day 1	—	—	8.3 scores on a scale Standard Deviation 11.79
EORTC QLQ-C30 Score Nausea and Vomiting, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Nausea and Vomiting, Follow Up	—	—	16.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Pain, Baseline	—	50.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	40.0 scores on a scale Standard Deviation 43.46
EORTC QLQ-C30 Score Pain, Cycle 3 Day 1	—	—	41.7 scores on a scale Standard Deviation 11.79
EORTC QLQ-C30 Score Pain, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Physical Functioning, Baseline	—	73.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	65.3 scores on a scale Standard Deviation 26.83
EORTC QLQ-C30 Score Physical Functioning, Cycle 3 Day 1	—	—	33.3 scores on a scale Standard Deviation 47.14
EORTC QLQ-C30 Score Physical Functioning, Cycle 6 Day 1	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Physical Functioning, Follow Up	—	—	40.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Role Functioning, Baseline	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	56.7 scores on a scale Standard Deviation 40.14
EORTC QLQ-C30 Score Role Functioning, Cycle 3 Day 1	—	—	33.3 scores on a scale Standard Deviation 47.14
EORTC QLQ-C30 Score Role Functioning, Cycle 6 Day 1	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Social Functioning, Baseline	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	53.3 scores on a scale Standard Deviation 36.13
EORTC QLQ-C30 Score Social Functioning, Cycle 3 Day 1	—	—	66.7 scores on a scale Standard Deviation 0.00
EORTC QLQ-C30 Score Social Functioning, Cycle 6 Day 1	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
EORTC QLQ-C30 Score Social Functioning, Follow Up	—	—	83.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.

SECONDARY outcome

Timeframe: Baseline; up to 160 days

Population: ITT Population. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=5 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Change From Baseline in the EORTC QLQ-C30 Score Pain, Cycle 3 Day 1	—	—	-8.3 scores on a scale Standard Deviation 58.93
Change From Baseline in the EORTC QLQ-C30 Score Pain, Follow Up	—	—	-83.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Appetite Loss, Cycle 3 Day 1	—	—	-16.7 scores on a scale Standard Deviation 23.57
Change From Baseline in the EORTC QLQ-C30 Score Appetite Loss, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Appetite Loss, Follow Up	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Cognitive Functioning, Cycle 3 Day 1	—	—	33.3 scores on a scale Standard Deviation 23.57
Change From Baseline in the EORTC QLQ-C30 Score Cognitive Functioning, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Cognitive Functioning, Follow Up	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Constipation, Cycle 3 Day 1	—	—	-33.3 scores on a scale Standard Deviation 0.00
Change From Baseline in the EORTC QLQ-C30 Score Constipation, Cycle 6 Day 1	—	—	-33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Constipation, Follow Up	—	—	-33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Diarrhea, Cycle 3 Day 1	—	—	-50.0 scores on a scale Standard Deviation 70.71
Change From Baseline in the EORTC QLQ-C30 Score Diarrhea, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Diarrhea, Follow Up	—	—	-66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Dyspnea, Cycle 3 Day 1	—	—	0.0 scores on a scale Standard Deviation 0.00
Change From Baseline in the EORTC QLQ-C30 Score Dyspnea, Cycle 6 Day 1	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Dyspnea, Follow Up	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Emotional Functioning, Cycle 3 Day 1	—	—	12.5 scores on a scale Standard Deviation 29.46
Change From Baseline in the EORTC QLQ-C30 Score Emotional Functioning, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Emotional Functioning, Follow Up	—	—	41.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Fatigue, Cycle 3 Day 1	—	—	-11.1 scores on a scale Standard Deviation 15.71
Change From Baseline in the EORTC QLQ-C30 Score Fatigue, Cycle 6 Day 1	—	—	11.1 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Fatigue, Follow Up	—	—	-44.4 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Financial Difficulties, Cycle 3 Day 1	—	—	0.0 scores on a scale Standard Deviation 0.00
Change From Baseline in the EORTC QLQ-C30 Score Financial Difficulties, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Financial Difficulties, Follow Up	—	—	-33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Global Health Status/QoL, Cycle 3 Day 1	—	—	33.3 scores on a scale Standard Deviation 35.36
Change From Baseline in the EORTC QLQ-C30 Score Global Health Status/QoL, Cycle 6 Day 1	—	—	16.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Global Health Status/QoL, Follow Up	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Insomnia, Cycle 3 Day 1	—	—	-16.7 scores on a scale Standard Deviation 23.57
Change From Baseline in the EORTC QLQ-C30 Score Insomnia, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Insomnia, Follow Up	—	—	-33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Nausea and Vomiting, Cycle 3 Day 1	—	—	0.0 scores on a scale Standard Deviation 0.00
Change From Baseline in the EORTC QLQ-C30 Score Nausea and Vomiting, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Nausea and Vomiting, Follow Up	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Pain, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Physical Functioning, Cycle 3 Day 1	—	—	-26.7 scores on a scale Standard Deviation 37.71
Change From Baseline in the EORTC QLQ-C30 Score Physical Functioning, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Physical Functioning, Follow Up	—	—	-13.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Role Functioning, Cycle 3 Day 1	—	—	0.0 scores on a scale Standard Deviation 0.00
Change From Baseline in the EORTC QLQ-C30 Score Role Functioning, Cycle 6 Day 1	—	—	0.0 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Role Functioning, Follow Up	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Social Functioning, Cycle 3 Day 1	—	—	41.7 scores on a scale Standard Deviation 11.79
Change From Baseline in the EORTC QLQ-C30 Score Social Functioning, Cycle 6 Day 1	—	—	33.3 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EORTC QLQ-C30 Score Social Functioning, Follow Up	—	—	66.7 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.

SECONDARY outcome

Timeframe: up to 160 days

Population: ITT Population. Only participants with available data were analyzed

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 \[worst overall health\] to 100 \[best overall health\]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.

Outcome measures

Outcome measures
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=5 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 4 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 7 Day 1 · 2	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Baseline · 4	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Baseline · 5	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 4 Day 1 · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 4 Day 1 · 2	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 4 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 4 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 4 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 7 Day 1 · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 7 Day 1 · 2	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 7 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 7 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Cycle 7 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Follow Up · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Follow Up · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Follow Up · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Follow Up · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Follow Up · 5	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Baseline · 1	—	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Baseline · 2	—	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Baseline · 3	—	1 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Baseline · 4	—	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Baseline · 5	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 4 Day 1 · 1	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 4 Day 1 · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 4 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 4 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 4 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 7 Day 1 · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 7 Day 1 · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 7 Day 1 · 3	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 7 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Cycle 7 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Follow Up · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Follow Up · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Follow Up · 3	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Follow Up · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Pain/Discomfort, Follow Up · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Baseline · 1	—	0 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Baseline · 2	—	1 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Baseline · 3	—	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Baseline · 4	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Baseline · 5	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 4 Day 1 · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 4 Day 1 · 2	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 4 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 4 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 4 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 7 Day 1 · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 7 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 7 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Cycle 7 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Follow Up · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Follow Up · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Follow Up · 3	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Follow Up · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Self-care, Follow Up · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Baseline · 1	—	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Baseline · 2	—	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Baseline · 3	—	1 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Baseline · 4	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Baseline · 5	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 4 Day 1 · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 4 Day 1 · 2	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 4 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 4 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 4 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 7 Day 1 · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 7 Day 1 · 2	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 7 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 7 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Cycle 7 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Follow Up · 1	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Follow Up · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Follow Up · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Follow Up · 4	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Usual Activities, Follow Up · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Baseline · 1	—	0 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Baseline · 2	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Baseline · 3	—	1 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Baseline · 4	—	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Baseline · 5	—	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 4 Day 1 · 1	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 4 Day 1 · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 4 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 4 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 7 Day 1 · 1	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 7 Day 1 · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 7 Day 1 · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 7 Day 1 · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Cycle 7 Day 1 · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Follow Up · 1	—	—	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Follow Up · 2	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Follow Up · 3	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Follow Up · 4	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Anxiety/Depression, Follow Up · 5	—	—	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Baseline · 1	—	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Baseline · 2	—	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores Mobility, Baseline · 3	—	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline; up to 160 days

Population: ITT Population. Only participants with available data were analyzed

Outcome measures

Outcome measures
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 Participants Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=5 Participants Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score Baseline	—	40 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.	52 scores on a scale Standard Deviation 30.54
Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score Cycle 4 Day 1	—	—	5 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score Cycle 7 Day 1	—	—	5 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.
Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score Follow Up	—	—	30 scores on a scale Standard Deviation NA A standard deviation was not calculated when only 1 participant contributed to the analysis.

Adverse Events

Pemigatinib 13.5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).	Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg n=1 participants at risk Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.	Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg n=6 participants at risk Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Musculoskeletal and connective tissue disorders Bone pain	— 0/0 • up to 178 days. Deaths were monitored for up to 225 days. Treatment-emergent adverse events (TEAEs) were monitored for up to 178 days (for up to 30 days after last dose of study drug). TEAEs, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).	100.0% 1/1 • Number of events 1 • up to 178 days. Deaths were monitored for up to 225 days. Treatment-emergent adverse events (TEAEs) were monitored for up to 178 days (for up to 30 days after last dose of study drug). TEAEs, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).	0.00% 0/6 • up to 178 days. Deaths were monitored for up to 225 days. Treatment-emergent adverse events (TEAEs) were monitored for up to 178 days (for up to 30 days after last dose of study drug). TEAEs, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
Infections and infestations COVID-19	— 0/0 • up to 178 days. Deaths were monitored for up to 225 days. Treatment-emergent adverse events (TEAEs) were monitored for up to 178 days (for up to 30 days after last dose of study drug). TEAEs, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).	0.00% 0/1 • up to 178 days. Deaths were monitored for up to 225 days. Treatment-emergent adverse events (TEAEs) were monitored for up to 178 days (for up to 30 days after last dose of study drug). TEAEs, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).	16.7% 1/6 • Number of events 1 • up to 178 days. Deaths were monitored for up to 225 days. Treatment-emergent adverse events (TEAEs) were monitored for up to 178 days (for up to 30 days after last dose of study drug). TEAEs, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).

Other adverse events

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Publication restrictions are in place

Restriction type: OTHER