FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with
 FGFR2
 rearrangements

Bekaii‐Saab, Tanios; Valle, Juan W.; Cutsem, Éric Van; Rimassa, Lorenza; Furuse, Junji; Ioka, Tatsuya; Melisi, Davide; Macarulla, Teresa; Bridgewater, John; Wasan, Harpreet; Borad, Mitesh J.; Abou‐Alfa, Ghassan K.; Jiang, Ping; Lihou, Christine; Zhen, Huiling; Asatiani, Ekaterine; Féliz, Luis; Vogel, Arndt

doi:10.2217/fon-2020-0429

Cited by 132 publications

(97 citation statements)

References 54 publications

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“…Moreover, systemic chemotherapy (SYS) alone has limited efficacy, with an overall survival (OS) of 15-19 -months for patients with liver-limited IHC in some series 12,13 . Although tumor mutational profiling has led to the use of targeted therapies for patients with IDH1 mutations (mut) and FGFR2 fusions (fus), the role and impact of these agents remains to be determined, and a survival benefit over SYS has not yet been demonstrated [14][15][16] .…”

Section: Introductionmentioning

confidence: 99%

Intrahepatic Cholangiocarcinoma with Lymph Node Metastasis: Treatment-Related Outcomes and the Role of Tumor Genomics in Patient Selection

Jolissaint

Soares

Seier

et al. 2021

Clinical Cancer Research

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In this manuscript, we demonstrate that hepatic arterial infusion chemotherapy (HAIC) may provide comparable survival to resection for patients with liver-limited intrahepatic cholangiocarcinoma (IHC) and lymph node metastases (LNM). HAIC is an attractive form of liver-directed therapy and can be offered with lower morbidity and mortality risk than liver resection, while also providing adequate disease control for traditionally unresectable patients.Moreover, this manuscript bridges the translational connection between genomics and clinical care by analyzing the next generation sequencing (NGS) data for this cohort of patients, treated with both modalities. Patients with N1 disease and high-risk alterations, which included mutations in KRAS and TP53, and deletions in CDKN2A and CDKN2B, had significantly worse prognosis, regardless of treatment. Conversely, mutations in IDH1 and IDH2 as well as FGFR2 fusion events, had no association with survival. Our results support the routine use of NGS in all patients with IHC, which may provide valuable insights into which patients are unlikely to derive benefit from any form of liver-directed therapy Research.

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Section: Introductionmentioning

confidence: 99%

Intrahepatic Cholangiocarcinoma with Lymph Node Metastasis: Treatment-Related Outcomes and the Role of Tumor Genomics in Patient Selection

Jolissaint

Soares

Seier

et al. 2021

Clinical Cancer Research

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“…On the basis of these positive results, pemigatinib has been recently approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma, with a FGFR2 fusion or other rearrangement. Pemigatinib is also under evaluation as a first-line treatment vs. gemcitabine plus cisplatin in patients with advanced CCA, with FGFR2 rearrangements in a phase III study (FIGHT-302) (NCT03656536) [ 54 ]. Infigratinib (BGJ398) is currently being evaluated in Phase III clinical trial as a first-line treatment in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations (NCT03773302).…”

Section: Targeted Therapy: State-of-the-art and Future Perspectivesmentioning

confidence: 99%

Molecular Landscape and Therapeutic Strategies in Cholangiocarcinoma: An Integrated Translational Approach towards Precision Medicine

Casadio

Biancaniello

Overi

et al. 2021

IJMS

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Cholangiocarcinomas (CCAs) are heterogeneous biliary tract malignancies with dismal prognosis, mainly due to tumor aggressiveness, late diagnosis, and poor response to current therapeutic options. High-throughput technologies have been used as a fundamental tool in unveiling CCA molecular landscape, and several molecular classifications have been proposed, leading to various targeted therapy trials. In this review, we aim to analyze the critical issues concerning the status of precision medicine in CCA, discussing molecular signatures and clusters, related to both anatomical classification and different etiopathogenesis, and the latest therapeutic strategies. Furthermore, we propose an integrated approach comprising the CCA molecular mechanism, pathobiology, clinical and histological findings, and treatment perspectives for the ultimate purpose of improving the methods of patient allocations in clinical trials and the response to personalized therapies.

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“…Since early 2019, the randomized trial “PROOF” has been recruiting patients in the first line for treatment with infigratinib versus GemCis (and possible crossover into the infigratinib arm) [33]. In addition, pemigatinib is further developed in first line in comparison to standard of care (GemCis) in the FIGHT-302 study (NCT03656536) [34], whereas derazantinib is evaluated in the FIDES-01 study in second line (NCT03230318).…”

Section: Targeted Therapiesmentioning

confidence: 99%

Current and Future Systemic Therapies in Biliary Tract Cancer

Vogel¹

2021

Visc Med

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Background: Despite an increasing incidence, biliary tumors are still considered a rare tumor entity. Due to an often long clinically inapparent course and a lack of early detection strategies, surgical resection is often not possible at the time of diagnosis. Since 2010, chemotherapy with gemcitabine and cisplatin is considered the standard of care in the palliative situation. Only recently, first studies have been published or initiated that expand the treatment options in the first line and, for the first time, also suggest valid systemic approaches in the second line. Summary: Molecularly targeted therapies in selected patient subgroups are rapidly changing the field. In addition to IDH1 mutations and FGFR2 fusions in patients with intrahepatic tumors, the therapeutic relevance of rare but targetable alterations such as HER2/neu amplification, NTRK fusions, or BRAF mutations should be considered in patients with biliary tract cancers. Key Message: The current study landscape clearly shows that precision medicine will play an important role in the therapy of biliary malignancies and underlines the importance of early tumor genetic diagnostics. In this article we provide an overview of systemic therapy concepts in the adjuvant and palliative setting.

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FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements

Cited by 132 publications

References 54 publications

Intrahepatic Cholangiocarcinoma with Lymph Node Metastasis: Treatment-Related Outcomes and the Role of Tumor Genomics in Patient Selection

Intrahepatic Cholangiocarcinoma with Lymph Node Metastasis: Treatment-Related Outcomes and the Role of Tumor Genomics in Patient Selection

Molecular Landscape and Therapeutic Strategies in Cholangiocarcinoma: An Integrated Translational Approach towards Precision Medicine

Current and Future Systemic Therapies in Biliary Tract Cancer

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