The NDS is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma. Study results demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 36 percent (primary endpoint), and median duration of response (DOR) of 9.1 months (secondary endpoint) with a median follow-up of 21 months. Adverse events observed included Retinal Pigment Epithelial Detachment (RPED) and hyperphosphatemia. The most common adverse reactions (incidence ≥ 20%) are hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, arthralgia, abdominal pain, hypophosphatemia, back pain, and dry skin.
"The need for new therapies for patients with cholangiocarcinoma remains urgent, as they have limited treatment options beyond first-line chemotherapy and often face a poor prognosis," said
Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its anatomical origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor.1,2 The incidence of cholangiocarcinoma varies regionally and ranges between 0.3-3.4 per 100,000 in
About FIGHT-202
The FIGHT-202 is a multi-center, open-label, single-arm, Phase 2 study (NCT02924376) that evaluated the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement.
Incyte Announces Health Canada Acceptance of the New Drug Submission
for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma
Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genomic alterations) or Cohort C (no FGF/FGFR genomic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.
The primary endpoint of FIGHT-202 was overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; and duration of response (DOR).
For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.
About FIGHT
The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating the safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations, irrespective of tumor type. FIGHT-205 is a Phase 2 study investigating pemigatinib plus pembrolizumab combination therapy and pemigatinib monotherapy as first-line treatment for metastatic or unresectable bladder cancer harboring FGFR3 mutations or rearrangements who are not eligible to receive cisplatin. FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.
About Pemigatinib
Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.
The safety and efficacy of pemigatinib is under review and the market authorization in
Pemigatinib is marketed by
About
Incyte is a Wilmington,
Incyte Announces Health Canada Acceptance of the New Drug Submission
for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma
Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether or when pemigatinib might be approved in
References | |
1. | Banales JM, et al. Nat Rev Gastroenterol Hepatol. 2016;13:261‒280. |
2. | Uhlig J, et al. Ann Surg Oncol. 2019;26:1993–2000. |
3. | Graham RP, et al. Hum Pathol. 2014;45:1630‒1638. |
4. | Farshidfar F, et al. Cell Rep. 2017;18(11):2780–2794. |
5. | Ross JS et al. The Oncologist. 2014;19:235–242. |
SOURCE Incyte Biosciences Canada
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