Interim results of fight-201, a phase II, open-label, multicenter study of INCB054828 in patients (pts) with metastatic or surgically unresectable urothelial carcinoma (UC) harboring fibroblast growth factor (FGF)/FGF receptor (FGFR) genetic alterations (GA)

Necchi, Andrea; Pouessel, Damien; Leibowitz-Amit, Raya; Fléchon, Aude; Gupta, Sumati; Barthélémy, Philippe; Maio, M.; Zhu, Xinhua; Asatiani, Ekaterine; Serbest, Gulyeter; Zhen, Huiling; Loriot, Yohann

doi:10.1093/annonc/mdy283.109

Cited by 43 publications

(32 citation statements)

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“…Specifically, 26% of patients treated with infigratinib [35], 46% of those treated with pemigatinib [22], and 24% of patients treated with derazantinib [39] experienced grade 1 or 2 alopecia. In patients with urothelial carcinoma, grade 1 or 2 alopecia occurred in 31%, 39%, and 29% of patients treated with infigratinib [40], pemigatinib [41], and erdafitinib [34].…”

Section: Dermatologic Events In Patients Treated With Fgfr Tkis: Skin Hair Nails and Oral Mucosamentioning

confidence: 99%

Dermatologic Adverse Events Associated with Selective Fibroblast Growth Factor Receptor Inhibitors: Overview, Prevention, and Management Guidelines

et al. 2020

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Fibroblast growth factor receptor (FGFR) tyrosine kinases, which are expressed on the cell membrane, are involved in a wide range of biological functions such as cell proliferation, survival, migration, and differentiation. The identification of FGFR fusions and other alterations in a wide range of solid tumors, including cholangiocarcinoma and bladder cancer, has resulted in the development of several selective FGFR inhibitors for use in these indications, for example, infigratinib, erdafitinib, derazantinib, pemigatinib, and futibatinib. In addition to the typical adverse events associated with tyrosine kinases, the FGFR inhibitors appear to give rise to a number of adverse events affecting the skin. Here we describe these skin events, which include the more common nail adverse events (e.g., onycholysis), palmar-plantar erythrodysesthesia syndrome, and stomatitis, as well as less common reactions such as calciphylaxis. This review aims to provide oncologists with an understanding of these dermatologic events and proposes guidelines for the management of treatment-emergent dermatologic adverse events. Awareness of possible adverse events associated with specific drugs should allow physicians to educate patients as to what to expect and implement effective management plans at the earliest possible opportunity, thereby preventing premature discontinuation while maintaining patient quality of life. The Oncologist 2020;25:1-11 Implications for Practice: Identification of fibroblast growth factor receptor (FGFR) aberrations in cholangiocarcinoma and bladder cancer led to development of selective FGFR inhibitors for these indications, based on clinical benefit and safety profiles. The most frequent adverse events (AEs) include those affecting skin, hair, and nails, a unique class effect of these agents. These are usually mild to moderate in severity. This work reviewed skin AEs reported with FGFR inhibitors and provides management guidelines for physicians, aiming to increase awareness of skin events and provide effective treatment strategies. Early intervention and effective management may improve treatment adherence, optimize outcomes, and improve quality of life.

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Section: Dermatologic Events In Patients Treated With Fgfr Tkis: Skin Hair Nails and Oral Mucosamentioning

confidence: 99%

Dermatologic Adverse Events Associated with Selective Fibroblast Growth Factor Receptor Inhibitors: Overview, Prevention, and Management Guidelines

et al. 2020

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“…Pemigatinib is another potent and competitive oral inhibitor of the kinase activity of FGFRs 1, 2 and 3. There was a phase II clinical trial (FIGHT-201) with mUC patients who progressed on one or several lines of therapy or were platinum ineligible [ 74 ]. Sixty-four patients with some FGFR3 mutation or fusion were assigned to cohort A, and 36 patients with other FGF/FGFR genetic mutations were assigned to cohort B and received pemigatinib.…”

Section: Targeting Fibroblast Growth Factor Receptor (Fgfr)mentioning

confidence: 99%

Novel Tyrosine Kinase Targets in Urothelial Carcinoma

Torres-Jiménez

Albarrán-Fernández

Pozas

et al. 2021

IJMS

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Urothelial carcinoma represents one of the most prevalent types of cancer worldwide, and its incidence is expected to grow. Although the treatment of the advanced disease was based on chemotherapy for decades, the developments of different therapies, such as immune checkpoint inhibitors, antibody drug conjugates and tyrosine kinase inhibitors, are revolutionizing the therapeutic landscape of this tumor. This development coincides with the increasing knowledge of the pathogenesis and genetic alterations in urothelial carcinoma, from the non-muscle invasive setting to the metastatic one. The purpose of this article is to provide a comprehensive review of the different tyrosine kinase targets and their roles in the therapeutic scene of urothelial carcinoma.

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“…Pemigatinib is a potent, oral, selective inhibitor of FGFR1–3. Necchi and colleagues presented an interim analysis of phase II clinical trial (FIGHT‐201) in patients with advanced or metastatic urothelial cancer who previously progressed on one or more lines of therapy or are platinum ineligible [26]. Sixty‐four patients with FGFR3 mutation or fusion were assigned to cohort A, and 36 patients with other FGF/ FGFR genetic mutations were assigned to cohort B and received pemigatinib.…”

Section: Pemigatinibmentioning

confidence: 99%

Fibroblast Growth Factor Receptor (FGFR) Inhibitors in Urothelial Cancer

Garje

Obeidat

et al. 2020

The Oncologist

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Dysregulated fibroblast growth factor receptor (FGFR) signaling is associated with several cancers, including urothelial carcinoma. Preclinical studies with FGFR inhibitors have shown significant antitumor activity, which has led to clinical evaluation of multiple FGFR inhibitors. Recently, erdafitinib was approved by the U.S. Food and Drug Administration for advanced urothelial carcinoma with FGFR gene alterations as the first molecularly targeted therapy. Additional ongoing clinical trials with other types of FGFR inhibitors have shown encouraging results. This review summarizes the oncogenic signaling of FGFR alterations, completed and ongoing clinical trials of FGFR inhibitors, and resistance patterns. Implications for Practice Dysregulated fibroblast growth factor receptor (FGFR) signaling is associated with several cancers, including urothelial carcinoma. Preclinical studies with FGFR inhibitors have shown significant antitumor activity, which has led to clinical evaluation of multiple FGFR inhibitors. Most recently, erdafitinib was approved by the U.S. Food and Drug Administration for advanced urothelial carcinoma with FGFR gene alterations as the first molecularly targeted therapy. Additional ongoing clinical trials with other types of FGFR inhibitors have shown encouraging results. This review summarizes the oncogenic signaling of FGFR alterations, completed and ongoing clinical trials of FGFR inhibitors, and resistance patterns.

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Interim results of fight-201, a phase II, open-label, multicenter study of INCB054828 in patients (pts) with metastatic or surgically unresectable urothelial carcinoma (UC) harboring fibroblast growth factor (FGF)/FGF receptor (FGFR) genetic alterations (GA)

Cited by 43 publications

References 0 publications

Dermatologic Adverse Events Associated with Selective Fibroblast Growth Factor Receptor Inhibitors: Overview, Prevention, and Management Guidelines

Dermatologic Adverse Events Associated with Selective Fibroblast Growth Factor Receptor Inhibitors: Overview, Prevention, and Management Guidelines

Novel Tyrosine Kinase Targets in Urothelial Carcinoma

Fibroblast Growth Factor Receptor (FGFR) Inhibitors in Urothelial Cancer

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