The purpose of this study is to confirm the efficacy and safety of pemigatinib in participants with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 fusion or rearrangements after at least 1 prior line of systemic therapy.
Histologically or cytologically confirmed unresectable, locally advanced or metastatic cholangiocarcinoma (CCA).
Documented FGFR2 fusion or rearrangement
Documented disease progression after at least 1 prior line of systemic chemotherapy, with or without immune checkpoint inhibitors (ICI).
Life expectancy ≥ 12 weeks.
Prior treatment with any FGFR inhibitor for any indication.
Liver cirrhosis, Child-Pugh B and C.
Known CNS metastases or history of uncontrolled seizures, except participants with treated brain metastases and no evidence of progression for => 4 weeks and on stable or decreasing dose of corticosteroids for management of CNS metastases for =>1 week.
Current evidence of clinically significant corneal or retinal as confirmed by ophthalmologic examination.
Single group
Pemigatinib
DrugPemigatinib at the protocol-defined dose administered orally once daily in 21-day cycles with 14 days on therapy followed by 7 days off therapy.
Objective Response
Defined as having a confirmed best response of complete response (CR) or partial response (PR), as determined by an independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Duration of Response (DoR)
Determined from earliest date of CR or PR until the earliest date of progressive disease (PD) as determined by an ICR per RECIST v1.1 or death due to any cause.
Progression-free survival (PFS)
Determined from start of therapy until the earliest date of PD as determined by an ICR per RECIST v1.1 or death due to any cause.
Overall Survival (OS)
Determined from the start of therapy until death due to any cause.
Number of treatment-emergent adverse events
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until up to 30 days after the last dose of study drug.
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