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|Ref Type||Journal Article|
|Authors||Pal SK, Rosenberg JE, Hoffman-Censits JH, Berger R, Quinn DI, Galsky MD, Wolf J, Dittrich C, Keam B, Delord JP, Schellens JHM, Gravis G, Medioni J, Maroto P, Sriuranpong V, Charoentum C, Burris HA, Grünwald V, Petrylak D, Vaishampayan U, Gez E, De Giorgi U, Lee JL, Voortman J, Gupta S, Sharma S, Mortazavi A, Vaughn DJ, Isaacs R, Parker K, Chen X, Yu K, Porter D, Graus Porta D, Bajorin DF|
|Title||Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations.|
|Abstract Text||BGJ398, a potent and selective pan-FGFR antagonist, was prospectively evaluated in patients with metastatic urothelial carcinoma bearing a diverse array of FGFR3 alterations. Patients (N = 67) who were unable to receive platinum chemotherapy were enrolled. The majority (70.1%) had received two or more prior antineoplastic therapies. BGJ398 was administered orally at 125 mg/day on a 3 weeks on, 1 week off schedule until unacceptable toxicity or progression. The primary endpoint was the response rate. Among 67 patients treated, an overall response rate of 25.4% was observed and an additional 38.8% of patients had disease stabilization, translating to a disease control rate of 64.2%. The most common treatment-emergent toxicities were hyperphosphatemia, elevated creatinine, fatigue, constipation, and decreased appetite. Further examination of BGJ398 in this disease setting is warranted.Significance: BJG398 is active in patients with alterations in FGFR3, resulting in both reductions in tumor volume and stabilization of disease. Our data highlight putative mechanisms of resistance to the agent, which may be useful in following disease status. Cancer Discov; 8(7); 812-21. ©2018 AACR.This article is highlighted in the In This Issue feature, p. 781.|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Therapy Name||Drugs||Efficacy Evidence||Clinical Trials|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|FGFR3 V555M FGFR3 L608V||transitional cell carcinoma||resistant||Infigratinib||Case Reports/Case Series||Actionable||In a clinical study, a patient with metastatic urothelial carcinoma progressed while being treated with Infigratinib (BGJ398) and subsequent cell-free DNA testing revealed FGFR3 V555M (also corresponds to V443M) and FGFR3 L608V (also corresponds to L496V) (PMID: 29848605).||29848605|
|FGFR3 V555L||transitional cell carcinoma||resistant||Infigratinib||Case Reports/Case Series||Actionable||In a clinical study, two patients with metastatic urothelial carcinoma progressed while being treated with Infigratinib (BGJ398) and subsequent cell-free DNA testing revealed FGFR3 V555L (also corresponds to V443L) (PMID: 29848605).||29848605|
|FGFR3 V555M||transitional cell carcinoma||resistant||Infigratinib||Case Reports/Case Series||Actionable||In a clinical study, a patient with metastatic urothelial carcinoma progressed while being treated with Infigratinib (BGJ398) and subsequent cell-free DNA testing revealed FGFR3 V555M (also corresponds to V443M) (PMID: 29848605).||29848605|
|FGFR3 mutant||transitional cell carcinoma||sensitive||Infigratinib||Clinical Study||Actionable||In a clinical study, Infigratinib (BGJ398) treatment in patients with FGFR3 alterations led to 25.4% (17/67) confirmed responses and a disease control rate of 64% (43/67), which included complete responses, partial responses, and stable disease, and resulted in a median progression-free survival of 3.75 months and a median overall survival of 7.75 months (PMID: 29848605).||29848605|