Pemigatinib administered orally once daily.

Pemigatinib

Incyte Medical Monitor

The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.

Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 \[excluding kinase domain\]) but there is no difference in the treatment regimen between the cohorts.

Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology \[RANO\]) or death (whichever is first) in each cohort.

Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.

Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.

Defined as the time from first dose of study drug to death of any cause in each cohort.

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Incyte Corporation

Treatment-emergent adverse events, 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).

Participants will receive 13.5mg QD Pemigatinib

Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements

Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

No participants were enrolled in Cohort B.

The Sponsor made a decision unrelated to safety to halt study enrollment. Due to early termination of the study with only1 participant, no analysis of efficacy endpoints was done.

Spots Global Cancer Trial Database for fgfr translocation