"For appropriate patients with cholangiocarcinoma, the approval of Pemazyre in
"Cholangiocarcinoma is a rare cancer of the bile duct with limited treatment options. As a result, patients face a poor prognosis," said Dr.
The conditional approval 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 harbouring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 35.5 percent (primary endpoint) and median duration of response (DOR) of 9.1 months (secondary endpoint) with a median follow-up of 15.4 months. Adverse events observed included serous retinal detachment (SRD) and hyperphosphatemia. The most common adverse reactions (incidence ≥15%) are hyperphosphatemia, alopecia, diarrhea, fatigue, nail toxicity, dysgeusia, nausea, constipation, stomatitis, dry mouth, decreased appetite, vomiting, dry eye, arthralgia, abdominal pain, hypophosphatemia, dry skin, edema peripheral, weight decreased, headache, urinary tract infection, dehydration, hypercalcemia, and palmar-plantar erythrodysaesthesia syndrome.
"We are pleased that
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.
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 tumour malignancies harbouring activating FGFR mutations or translocations, irrespective of tumour 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 harbouring 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 Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.6
In
In
In
Pemazyre 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.
Pemazyre is marketed by
Pemazyre is a trademark of
About
Incyte is a Wilmington,
To learn more about Incyte Biosciences Canada, visit https://incytebiosciences.ca.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the FIGHT clinical trial program and whether Pemazyre might provide a successful treatment option for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by Canadian regulatory authorities or other regulatory authorities, including the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company's reports filed with the
_______________________________ | |
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. |
6 | Pemazyre® (pemigatinib) [Product Monograph]. |
SOURCE Incyte Biosciences Canada
© Canada Newswire, source