Therapy Detail
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| Therapy Name | Pemigatinib |
| Synonyms | |
| Therapy Description |
Pemigatinib (INCB054828) is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR1/2/3 signaling, which results in growth inhibition in tumor cells (Ann Oncol, 29 (suppl 8), October 2018, abstract 756P). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Pemigatinib | Pemazyre | INCB54828|INCB054828 | FGFR1 Inhibitor 23 FGFR2 Inhibitor 16 FGFR3 Inhibitor 12 | Pemazyre (pemigatinib) is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR1/2/3 signaling, which results in growth inhibition in tumor cells (PMID: 32203698). Pemazyre (pemigatinib) is FDA approved for use in patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR1 mutant | Advanced Solid Tumor | sensitive | Pemigatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). | detail... |
| FGFR2 mutant | Advanced Solid Tumor | sensitive | Pemigatinib | Preclinical - Cell culture | Actionable | In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). | detail... |
| FGFR2 - CLIP1 FGFR2 N549H | cholangiocarcinoma | predicted - resistant | Pemigatinib | Case Reports/Case Series | Actionable | In a clinical case study, a cholangiocarinoma patient harboring FGFR2-CLIP1 demonstrated an initial partial response following treatment with Pemazyre (pemigatinib), but progressed after 5 months, and was determined to have an acquired FGFR2 N549H mutation (PMID: 31371345). | 31371345 |
| FGFR1 rearrange | myeloid and lymphoid neoplasms associated with FGFR1 abnormalities | sensitive | Pemigatinib | Guideline | Actionable | Pemazyre (pemigatinib) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an FGFR1 rearrangement (NCCN.org). | detail... |
| FGFR2 - BICC1 | cholangiocarcinoma | sensitive | Pemigatinib | Phase II | Actionable | In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response rate (ORR) of 35.5% (38/107, 3 complete response, 35 partial response) in patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, 29% (31/107) of the patients harbored FGFR2-BICC1 and achieved an ORR (32.3%, 10/31) and a median progression-free survival (6.80 vs 6.93 months) comparable to the entire group (PMID: 32203698; NCT02924376). | 32203698 |
| FGFR2 - CLIP1 | cholangiocarcinoma | predicted - sensitive | Pemigatinib | Case Reports/Case Series | Actionable | In a clinical case study, a cholangiocarinoma patient harboring FGFR2-CLIP1 demonstrated a partial response following treatment with Pemazyre (pemigatinib) (PMID: 31371345). | 31371345 |
| FGFR2 rearrange | cholangiocarcinoma | sensitive | Pemigatinib | FDA approved - Has Companion Diagnostic | Actionable | In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response in 35.5% (38/107, 3 complete response, 35 partial response) of patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, with a disease control rate of 82% (88/107), median time-to-response of 2.7 months, and a median progression-free survival of 6.9 months (PMID: 32203698; NCT02924376). | detail... 32203698 detail... |
| FGFR2 rearrange | cholangiocarcinoma | sensitive | Pemigatinib | Guideline | Actionable | Pemazyre (pemigatinib) is included in guidelines as subsequent-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (NCCN.org). | detail... |
| FGFR3 mutant | Advanced Solid Tumor | sensitive | Pemigatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). | detail... |
| FGFR2 - CLIP1 | Advanced Solid Tumor | sensitive | Pemigatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Pemazyre (pemigatinib) treatment inhibited viability of a transformed cell line expressing FGFR2-CLIP1 in culture (PMID: 31371345). | 31371345 |
| FGFR2 - CLIP1 FGFR2 N549H | Advanced Solid Tumor | resistant | Pemigatinib | Preclinical - Cell culture | Actionable | In a preclinical study, a transformed cell line expressing both FGFR2-CLIP1 and FGFR2 N549H demonstrated resistance to Pemazyre (pemigatinib) treatment in culture (PMID: 31371345). | 31371345 |
| FGFR2 fusion | cholangiocarcinoma | sensitive | Pemigatinib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response in 35.5% (38/107, 3 complete response, 35 partial response) of patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, with a disease control rate of 82% (88/107), median time-to-response of 2.7 months, and a median progression-free survival of 6.9 months (PMID: 32203698; NCT02924376). | detail... 32203698 detail... |
| FGFR2 fusion | cholangiocarcinoma | sensitive | Pemigatinib | Guideline | Actionable | Pemazyre (pemigatinib) is included in guidelines as subsequent-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02872714 | Phase II | Pemigatinib | A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) | Active, not recruiting | USA | 10 |
| NCT03011372 | Phase II | Pemigatinib | A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) | Recruiting | USA | CAN | 9 |
| NCT03914794 | Phase II | Pemigatinib | A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors | Recruiting | USA | 0 |
| NCT03822117 | Phase II | Pemigatinib | Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) | Recruiting | USA | 10 |
| NCT02924376 | Phase II | Pemigatinib | Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy | Active, not recruiting | USA | 11 |
| NCT03656536 | Phase III | Pemigatinib Cisplatin + Gemcitabine | A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302) | Recruiting | USA | CAN | 16 |
| NCT04003623 | Phase II | Pemigatinib | Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) | Recruiting | USA | 0 |
| NCT04096417 | Phase II | Pemigatinib | Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations | Recruiting | USA | 0 |
| NCT04003610 | Phase II | Pembrolizumab + Pemigatinib Pembrolizumab Carboplatin + Gemcitabine Pemigatinib | Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) | Active, not recruiting | USA | CAN | 14 |
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