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Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1–3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations
Sumanta K. Pal ,
Jonathan E. Rosenberg ,
Jean H. Hoffman-Censits ,
Raanan Berger ,
David I. Quinn ,
Matthew D. Galsky ,
Juergen Wolf ,
Christian Dittrich ,
Bhumsuk Keam ,
Jean-Pierre Delord ,
Jan H.M. Schellens ,
Gwenaelle Gravis ,
Jacques Medioni ,
Pablo Maroto ,
Virote Sriuranpong ,
Chaiyut Charoentum ,
Howard A. Burris ,
Viktor Grünwald ,
Daniel Petrylak ,
Ulka Vaishampayan ,
Eliahu Gez ,
Ugo De Giorgi ,
Jae-Lyun Lee ,
Jens Voortman ,
Sumati Gupta ,
Sunil Sharma ,
Amir Mortazavi ,
David J. Vaughn ,
Randi Isaacs ,
Katie Parker ,
Xueying Chen ,
Kun Yu ,
Dale Porter ,
Diana Graus Porta ,
Dean F. Bajorin
July 01 2018
May 30 2018
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Abstract
<p class="first" id="P2">BGJ398, a potent and selective pan-fibroblast growth factor
receptor (FGFR) antagonist,
was prospectively evaluated in patients with metastatic urothelial carcinoma bearing
a diverse array of
<i>FGFR3</i> 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.
</p>