Pemazyre (pemigatinib) / Incyte, Innovent Biologics, Knight Therap, Specialised Therap - LARVOL DELTA

Comparative Efficacy and Safety of Biomarker-Guided Targeted Therapies Versus Conventional Treatment in Advanced Biliary Tract Cancer: A Systematic Review and Network Meta-Analysis (ACG 2026) - "14 studies involving 3,842 patients were included, comprising 2,116 males (55.1%) and 1,726 females (44.9%), with median age ranging from 58â69 years. Evaluated therapies included FGFR inhibitors (pemigatinib, futibatinib, infigratinib), the IDH1 inhibitor ivosidenib, HER2-directed regimens (trastuzumab-based therapies and zanidatamab), dabrafenib plus trametinib, zenocutuzumab, and conventional chemotherapy/immunotherapy controls. Most patients had metastatic disease (81.6%), ECOG 0â1 status (87.3%), and prior systemic therapy exposure."

Biomarker • IO biomarker • Metastases • Retrospective data • Review • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • FGFR2 • IDH1 • NRG1

Futibatinib, pemigatinib, or lirafugratinib for patients with biliary tract cancers and FGFR Alterations (ESMO 2026) - No abstract available

Clinical • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • FGFR

The Rome trial from histology to target: The road to personalize targeted therapy and immunotherapy (ESMO 2024) - P2 | "The most frequently assigned TTs were IPI/NIVO (37%), ipatasertib (16%), pemigatinib (8%), TDM1 (8%), and atezo/ipatasertib (6%). The ROME Trial demonstrated that a mutational-based treatment approach based on the MTB discussion of CGP results may significantly improve ORR and PFS compared to SoC in pretreated patients with metastatic solid tumors, particularly with immunotherapy."

IO biomarker • Late-breaking abstract • Tumor mutational burden • Biliary Cancer • Biliary Tract Cancer • Brain Cancer • CNS Tumor • Gastrointestinal Cancer • Glioblastoma • Oncology • Solid Tumor • FGFR • HER-2 • PIK3CA • PTEN

Pemigatinib + Afatinib in Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Massachusetts General Hospital | N=70 ➔ 32

Enrollment change • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • FGFR2

Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial. (PubMed, Lancet Gastroenterol Hepatol) - P2 | "These findings suggest that tinengotinib might have activity in patients with cholangiocarcinoma with FGFR2 fusions that progressed following FGFR inhibitor therapy. Anti-tumour activity was also observed in patients with other FGFR alterations. The data from this phase 2 study supported the initiation of a phase 3 registration trial."

Journal • P2 data • Biliary Cancer • Cardiovascular • Cholangiocarcinoma • CNS Disorders • Dental Disorders • Dermatology • Hypertension • Oncology • Solid Tumor • Stomatitis • FGFR2

Open-label, dose-escalation FIGHT-101 study of pemigatinib combined with targeted therapy, chemotherapy, or immunotherapy in patients with advanced malignancies. (PubMed, ESMO Open) - P1/2 | "Pemigatinib combination therapy showed no unexpected toxicities. PK and pharmacodynamics were mostly consistent with pemigatinib monotherapy. Pemi/gem/cis (37.5%) and pemi/pembro (26.9%) had the highest ORR; most responders had FGFR alterations."

IO biomarker • Journal • Metastases • Oncology • Solid Tumor

Pemigatinib for Metastatic or Surgically Unresectable Urothelial Carcinoma With FGF/FGFR Genomic Alterations: Final Results From FIGHT-201. (PubMed, Ann Oncol) - P2 | "Pemigatinib was generally well tolerated and demonstrated clinical activity in previously treated, unresectable or metastatic UC with FGFR3 mutations or fusions/rearrangements."

Journal • Metastases • Alopecia • Dental Disorders • Immunology • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • Stomatitis • Urothelial Cancer • FGFR • FGFR3

An open-label study of pemigatinib in cholangiocarcinoma: final results from FIGHT-202. (PubMed, ESMO Open) - P2 | "Pemigatinib demonstrated durable response and prolonged OS with manageable AEs in patients with previously treated, advanced/metastatic CCA with FGFR2 alterations in the extended follow-up period of FIGHT-202."

Journal • Acute Kidney Injury • Alopecia • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • FGFR2

From upfront NGS to targeted therapy in cholangiocarcinoma: Real-world experience with pemigatinib (KSMO 2026) - "Sponsored by Hanidox"

Clinical • Next-generation sequencing • Real-world • Real-world evidence • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Progression-Free Survival in Patients With Cholangiocarcinoma With or Without FGF/FGFR Alterations: A FIGHT-202 Post Hoc Analysis of Prior Systemic Therapy Response. (PubMed, JCO Precis Oncol) - P2 | "In patients with CCA and FGFR2 fusions or rearrangements, second-line treatment with pemigatinib may be associated with longer PFS compared with second-line treatment with systemic therapy received before study enrollment; however, a prospective controlled trial is required to confirm this. The results support the therapeutic potential of pemigatinib previously demonstrated in FIGHT-202."

Journal • Retrospective data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR • FGFR2

Pemigatinib for Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement. (PubMed, NEJM Evid) - P2 | "In our study, pemigatinib manifested near complete efficacy in chronic-phase patients with MLN-FGFR1, while the complete response rate was close to 50% in blast-phase patients. Toxicities were manageable with dose modifications. (Funded by Incyte Corporation; FIGHT-203 ClinicalTrials.gov number, NCT03011372.)."

Journal • Dental Disorders • Hematological Malignancies • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Stomatitis • FGFR1

A phase 2 study of pemigatinib for pre-treated glioblastoma or other gliomas with activating FGFR1-3 alterations: Results from FIGHT-209. (ASCO 2025) - P2 | "ORR did not meet the pre-specified goal of > 28% among pts with GBM harboring pemigatinib-sensitizing FGFR alterations. However, durable disease stabilization was observed, notably in pts with CNS tumors other than GBM, and toxicities were manageable. More mature PFS and OS data will be presented with exploratory molecular correlations."

P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Glioneuronal Tumor • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • FGFR1

Establishing a Patient-derived organoid model to study FGFR inhibition response in FGFR3-TACC3 fusion Glioblastoma (EANO 2026) - "A pilot F3T3+ GBO model was exposed to four conditions: control (DMSO), FGFR inhibition (pemigatinib), standard chemoradiation (temozolomide plus radiotherapy), and combination therapy. We developed a patient-derived GBO platform to investigate resistance and sensitivity to FGFRi in F3T3+ GBMs. Initial findings indicate fusion-specific sensitivity to FGFR inhibition and reveal early adaptive responses under therapeutic pressure. Long-term cultures will be used to monitor the emergence of resistance mechanisms."

Clinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • FGFR3 • TACC3

Phase I results of a multicenter, open-label, dose de-escalation and expansion study of gemcitabine and cisplatin with ivosidenib or pemigatinib for advanced cholangiocarcinoma. (PubMed, Invest New Drugs) - "Adding ivosidenib to gemcitabine and cisplatin in this study demonstrated a challenging safety profile in advanced CCA. Further research and dose optimization are warranted to confirm these findings and optimize the integration of targeted therapies into first-line regimens."

IO biomarker • Journal • P1 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • FGFR2 • IDH1

Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for the Treatment of Unresectable, Locally Advanced or Metastatic Biliary Tract Cancers With FGFR2 Alterations (clinicaltrials.gov) - P2 | N=29 | Recruiting | Sponsor: Ohio State University Comprehensive Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Ampulla of Vater Carcinoma • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor • FGFR2

FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. (PubMed, Ann Oncol) - P1/2 | "Pemigatinib was associated with a manageable safety profile and pharmacodynamic and clinical activity, with responses seen across tumors and driven by FGFR fusions/rearrangements and mutations. These results prompted a registrational study in cholangiocarcinoma and phase II/III trials in multiple tumor types demonstrating the benefit of precision therapy even in early phase trials."

Journal • P1 data • Pan tumor • Astrocytoma • Biliary Cancer • Brain Cancer • Cholangiocarcinoma • Fatigue • Gastrointestinal Cancer • Lung Cancer • Metabolic Disorders • Nephrology • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Disease • Solid Tumor

Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. (PubMed, Nat Med) - P2 | "New therapeutic areas for FGFR inhibition and drug failure mechanisms were identified across tumor types. ClinicalTrials.gov identifier: NCT03822117 ."

Journal • P2 data • Pan tumor • Dental Disorders • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • Stomatitis • BAP1 • FGFR1 • FGFR3 • TP53

Genomic architecture of FGFR2 fusions in cholangiocarcinoma and its implication for molecular testing. (PubMed, Br J Cancer) - "This study provides a detailed presentation and dissection of the technical and biological aspects regarding FGFR2 fusion detection, which aims to support molecular pathologists, pathologists and clinicians in diagnostics, reporting of the results and decision-making."

Journal • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Mehmet Akce | Trial completion date: Jul 2027 ➔ Jul 2028 | Trial primary completion date: Jul 2026 ➔ Jul 2027

Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor • FGFR2

Activity of Pemigatinib in Pilocytic Astrocytoma and FGFR1 Mutation. (PubMed, JCO Precis Oncol) - No abstract available

Journal • Astrocytoma • Brain Cancer • Oncology • Solid Tumor • FGFR1

Improving public cancer care by implementing precision medicine in Norway (clinicaltrialsregister.eu) - P1/2 | N=1000 | Recruiting | Sponsor: Oslo University Hospital HF | N=6000 ➔ 1000

Enrollment change • Oncology

Pemigatinib for previously treated locally advanced or metastatic cholangiocarcinoma: final results from FIGHT-202 (ESMO-GI 2022) - P2 | "Conclusions 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."

Clinical • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR1 • FGFR2

Pemigatinib for Unresectable or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor-2 Rearrangement: Results From the Phase 3 FIGHT-302 Trial. (PubMed, J Clin Oncol) - P3 | "This was the largest, first-line, randomized, phase 3 trial of a targeted therapy for advanced FGFR2-rearranged cholangiocarcinoma. Pemigatinib demonstrated prolonged median PFS compared with chemotherapy, with no new safety findings."

Journal • P3 data • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • FGFR2

Pemigatinib for untreated unresectable/metastatic cholangiocarcinoma (mCCA) with fibroblast growth factor receptor-2 (FGFR2) rearrangement: Phase 3 FIGHT-302 results. (ASCO 2026) - P3 | " Patients (pts) aged ≥18 y with previously untreated mCCA with FGFR2 rearrangement were randomized 1:1 to receive oral pemigatinib (13.5 mg once daily q21) or intravenous chemotherapy (1000 mg/m2 gemcitabine + 25 mg/m2 cisplatin d1,8 q21 ≤8 cycles) stratified by previous receipt of 1 chemotherapy cycle, geographic region, and tumor burden. FIGHT-302 was the first phase 3 trial of a targeted therapy for untreated mCCA. Pemigatinb demonstrated superior activity and prolonged mPFS compared with first-line chemotherapy. The results confirm the current management paradigm of pemigatinib administration after disease progression on chemotherapy."

IO biomarker • Metastases • P3 data • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • FGFR2

Satellite Symposium 7 (SL07) From upfront NGS to targeted therapy in cholangiocarcinoma: Real-world experience with pemigatinib (KSMO 2026) - "Sponsored by Hanidox"

Clinical • Next-generation sequencing • Real-world • Real-world evidence • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor