Title:
New treatment for rare cancer cholangiocarcinoma approved in Australia
Excerpt:PEMAZYRE® (pemigatinib) has been provisionally approved by the Therapeutic Goods Administration (TGA) "for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy.
Title:
Innovent Announces the Approval of Pemazyre® (pemigatinib) by the NMPA for the Treatment of Adults with Locally Advanced or Metastatic Cholangiocarcinoma with A FGFR2 Fusion or Rearrangement As Confirmed By A Validated Diagnostic Test That Have Progressed
Excerpt:Innovent Biologics...announced that the National Medical Products Administration (NMPA) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy.
Title:
Innovent Announces the Approval of Pemazyre® (pemigatinib) in Hong Kong Market for the Treatment of Adults With Locally Advanced Or Metastatic Cholangiocarcinoma With A FGFR2 Fusion Or Rearrangement That Have Progressed After At Least One Prior Line Of Sy
Excerpt:Innovent Biologics, Inc. (Innovent) (HKEX: 01801)...announced that the Hong Kong Department of Health (DH) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Title:
Innovent Announces the Approval of Pemazyre® (pemigatinib) in Taiwan Market for the Treatment of Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with a FGFR2 Fusion or Rearrangement
Excerpt:Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company...announced that the Taiwan market has approved Pemazyre® (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement....Among the 107 patients with FGFR 2 fusion/rearrangement, the ORR was 35.5% (95% CI: 27%, 45%), including 3 complete responses.
Title:
Innovent Announces the Approval of Pemazyre® (pemigatinib) in Taiwan Market for the Treatment of Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with a FGFR2 Fusion or Rearrangement
Excerpt:Innovent Biologics, Inc. (Innovent) (HKEX: 01801)...announced that the Taiwan market has approved Pemazyre® (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement....The approval was based on the FIGHT-202 study, which is a Phase 2, multi-center, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of Pemazyre...
Excerpt:Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Title:
Incyte Announces Approval of Pemazyre (pemigatinib) in Japan for the Treatment of Patients with Unresectable Biliary Tract Cancer (BTC) with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene, Worsening After Cancer Chemotherapy
Excerpt:Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.
Excerpt: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 as detected by an FDA-approved test.
Evidence Level:Sensitive: A2 - Guideline
Title:
NICE recommends Incyte’s Pemazyre for rare bile duct cancer
Excerpt:NICE’s guidance recommends Pemazyre (pemigatinib) for the treatment of CCA with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy....The NICE decision is based on data from the FIGHT-202 study, which evaluated the FGFR isoform 1,2 and 3 inhibitor in adult patients with previously treated, locally advanced or metastatic CCA with documented FGF/FGFR status.
Evidence Level:Sensitive: A2 - Guideline
New
Excerpt:Biliary Tract Cancer: Useful in Certain Circumstances…For cholangiocarcinoma with FGFR2 fusions or rearrangements: Pemigatinib.
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Excerpt:...The existence of FGFR2 fusion/rearrangement was confirmed by gene detection; 4....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Excerpt:...ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions`ORR in All Participants With FGF/FGFR Alterations`ORR in Participants Negative for FGF/FGFR Alterations`Progression-free Survival (PFS)`Duration of Response (DOR)`Disease Control Rate (DCR)`Overall Survival`Number of Participants With Any Treatment-emergent Adverse Event (TEAE)`First-order Absorption Rate Constant (ka) of Pemigatinib`CL/F of Pemigatinib`Vc/F of Pemigatinib`Vp/F of Pemigatinib...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements
Excerpt:...Only CE-IVD marked NGS-tests are applicable which cover FGFR2 fusions and rearrangements...
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
121P - PemiBil: Efficacy and safety of pemigatinib in advanced cholangiocarcinoma with FGFR2 fusions/rearrangements in real-world, results of multicentric French cohort from ACABI consortium
Excerpt:The objective response rate was 45.3% (3 complete responses and 21 partial responses, n = 24). The median progression-free survival was 9 months (IIQ 6-14) and the median overall survival was 18 months (IIQ 12-NA)….Our study confirms the efficacy of pemigatinib in an unselected population with high response rates and survivals similar to the FIGHT-202 data. It also confirms the good tolerability of pemigatinib and the better prognosis of iCCA with FGFR2 f/r.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Pemigatinib in previously treated Chinese patients with locally advanced or metastatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements: A phase II study
Excerpt:In this ongoing, multicenter, single-arm, phase II study, adult patients with locally advanced or metastatic cholangiocarcinoma carrying centrally confirmed FGFR2 fusions or rearrangements who had progressed on ≥1 systemic therapy received 13.5 mg oral pemigatinib once daily (3-week cycle; 2 weeks on, 1 week off) until disease progression...Among 30 patients with FGFR2 fusions or rearrangements evaluated for efficacy, 15 patients achieved partial response (ORR, 50.0%; 95% confidence interval [CI], 31.3-68.7); 15 achieved stable disease, contributing to a disease control rate of 100% (95% CI, 88.4-100).
Evidence Level:Sensitive: C3 – Early Trials
Title:
PEMIGATINIB FOR PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA: FINAL RESULTS FROM FIGHT-202
Excerpt:Median (range) duration of follow-up was 45.4 (19.9–53.7) months. In total, 98.6% of patients discontinued treatment, most commonly for disease progression (n=105/147; 71.4%). In cohort A, ORR (95% CI) was 37.0% (27.9%–46.9%), DCR (95% CI) was 82.4% (73.9%–89.1%), and median DOR (95% CI) was 9.1 (6.0–14.5) months. For cohorts B and C, DCR was 40.0% (19.1%–63.9%) and 17.6% (3.8%–43.4%), respectively. Median (95% CI) PFS was 7.0 (6.1–10.5) months for cohort A, and 2.1 (1.2–4.9) and 1.5 (1.4–1.8) months for cohorts B and C, respectively. For cohorts A–C, median (95% CI) OS was 17.5 (14.4–22.9), 6.7 (2.1–10.6), and 4.0 (2.0–4.6) months...: In this analysis, pemigatinib continued to demonstrate durable response, prolonged OS, and a manageable safety profile in patients with advanced/metastatic CCA with FGFR2 fusions or rearrangements. These results further highlight the need for molecular testing in patients with CCA.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Real-world genomic testing, treatment, and outcomes in patients with cholangiocarcinoma with FGFR2 fusions/rearrangements.
Excerpt:Three FGFR2 f/r patients received an FGFR inhibitor (pemigatinib) as next treatment after testing in 2020. A trend towards longer median overall survival in the f/r vs wt group (24.5 vs 17.8 mo)…
DOI:10.1200/JCO.2022.40.16_suppl.e16168
Evidence Level:Sensitive: C3 – Early Trials
Title:
Pemigatinib in Chinese patients with advanced/metastatic or surgically unresectable cholangiocarcinoma including FGFR2 fusion or rearrangement: Updated data from an open-label, single-arm, multicenter phase II study (CIBI375A201 study).
Excerpt:The other 31 subjects with documented FGFR2 fusion or rearrangement were enrolled in Part 2 and received 13.5 mg pemigatinib....Pemigatinib was high response rate and manageable tolerability in Chinese patients with recurrent or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement.
DOI:10.1200/JCO.2022.40.16_suppl.e16183
Evidence Level:Sensitive: C3 – Early Trials
Title:
Progression-Free Survival in Patients With Cholangiocarcinoma With or Without FGF/FGFR Alterations: A FIGHT-202 Post Hoc Analysis of Prior Systemic Therapy Response
Excerpt:Patients with locally advanced or metastatic CCA with FGFR2 fusions/rearrangements (n = 107)...documented disease progression after at least one systemic cancer therapy before enrollment in FIGHT-202 were assessed….The median PFS was 7.0 months (4.9 to 11.1) for patients with FGFR2 fusions/rearrangements (n = 65) with second-line pemigatinib received during the FIGHT-202 trial.
Evidence Level:Sensitive: C3 – Early Trials
Title:
SO-4 Progression-free survival in patients with cholangiocarcinoma with FGFR2 fusions or rearrangements: A FIGHT-202 post-hoc analysis of prior systemic therapy response
Excerpt:...patients with CCA harboring FGFR2 fusions or rearrangements (FGFR2+)...For patients who had progressed after 2 lines of prior therapies and then received pemigatinib third-line during FIGHT-202, median PFS was 8.9 (95% CI: 4.9, 13.1) months (n=30)...Median PFS on second- or third-line pemigatinib for FGFR2+ CCA was longer than second- or third-line systemic therapy received prior to FIGHT-202...
DOI:10.1016/j.annonc.2021.05.028
Evidence Level:Sensitive: C3 – Early Trials
Title:
Pemigatinib for previously treated locally advanced/metastatic cholangiocarcinoma (CCA): Update of FIGHT-202.
Excerpt:Pts (≥18 y) with known FGF/FGFR alterations and progression after ≥1 prior therapy had FGFR2 rearrangements/fusions (cohort A)... Independent, centrally confirmed ORR was 37.0%; mOS was 17.5 mo….These results reinforce the primary data, showing continued, durable responses and sustained tolerability in pts receiving PEMI for CCA harboring FGFR2 rearrangements/fusions.
DOI:10.1200/JCO.2021.39.15_suppl.4086
Evidence Level:Sensitive: C3 – Early Trials
Title:
Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement
Excerpt:Incyte (Nasdaq:INCY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement...The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Efficacy and safety of pemigatinib in European patients with previously treated locally advanced or metastatic cholangiocarcinoma: a FIGHT-202 subgroup analysis
Excerpt:FGF/FGFR genomic alterations (GAs)... FGFR2 fusions/rearrangement (RE)..Pts with advanced disease…assigned to cohort A (FGFR2 RE), B (other FGF/FGFR GA), or C (no FGF/FGFR GA). Pts received pemigatinib 13.5 mg QD.... In cohort A, ORR (95% confidence interval) was 40.6% (23.7-59.4) with 1 complete response (Figure); mDOR was 7.5 mo (5.5-7.5), DCR was 87.5% (71.0-96.5), mPFS was 6.9 mo (4.8-9.1), and mOS was 14.7 mo (11.7-not reached).
Evidence Level:Sensitive: C3 – Early Trials
Title:
Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study
Excerpt:...data support the therapeutic potential of pemigatinib in previously treated patients with cholangiocarcinoma who have FGFR2 fusions or rearrangements.
DOI:https://doi.org/10.1016/S1470-2045(20)30109-1
Evidence Level:Sensitive: C3 – Early Trials
Title:
2550 - FIGHT-202: a phase 2 study of pemigatinib in patients (pts) with previously treated locally advanced or metastatic cholangiocarcinoma (CCA)
Excerpt:ORR in cohort A was 35.5% (95% CI, 26.5%–45.4%), with 3 complete responses; median (m) DOR was 7.5 (95% CI, 5.7–14.5) months (mo), DCR was 82% (95% CI, 74%–89%), mPFS and mOS were 6.9 (95% CI, 6.2–9.6) and 21.1 (14.8–not reached) mo (OS not mature at cutoff)....These data support pemigatinib as a potential treatment option for previously treated pts with CCA harboring FGFR2 gene rearrangements/fusions.
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Pemigatinib for previously treated locally advanced or metastatic cholangiocarcinoma: final results from FIGHT-202
Excerpt:In this analysis, pemigatinib continued to demonstrate durable response, prolonged survival, and a manageable safety profile in patients with advanced/metastatic CCA with FGFR2 fusions or rearrangements.
DOI:http://dx.doi.org/10.1136/gutjnl-2022-BASL.69
Evidence Level:Sensitive: C4 – Case Studies
Title:
Pemigatinib treatment for intrahepatic cholangiocarcinoma with FGFR2 fusion detected by a liquid comprehensive genomic profiling test
Excerpt:A liver tumor biopsy was performed, which confirmed ICC….liquid CGP (FoundationOne® Liquid CDx, Foundation Medicine) was performed, and FGFR2 fusion was detected....Two months after initiating pemigatinib, a CT scan showed controlled intrahepatic lesions and other distant metastases, and the state of the cancer was considered a stable disease based on RECIST...