Format

Send to

Choose Destination
Cancer Discov. 2018 Jul;8(7):812-821. doi: 10.1158/2159-8290.CD-18-0229. Epub 2018 May 30.

Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations.

Author information

1
City of Hope, Duarte, California.
2
Memorial Sloan Kettering Cancer Center, New York, New York.
3
Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania.
4
The Chaim Sheba Medical Center, Ramat Gan, Israel.
5
USC Norris Cancer Center, Los Angeles, California.
6
The Mount Sinai Hospital, New York, New York.
7
Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany.
8
Applied Cancer Research-Institution for Translational Research Vienna (ACR-ITR VIEnna), Kaiser-Franz-Josef-Spital, Vienna, Austria.
9
Seoul National University Hospital, Seoul, South Korea.
10
IUCT Oncopole, Toulouse, France.
11
The Netherlands Cancer Institute, Amsterdam, the Netherlands.
12
Institut Paoli Calmettes, Marseilles, France.
13
Hôpital Européen Georges Pompidou, Paris, France.
14
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
15
Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
16
Maharaj Nakorn Chiangmai Hospital, Chiang Mai, Thailand.
17
Sarah Cannon Research Institute, Nashville, Tennessee.
18
Medical School Hannover, Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover, Germany.
19
Yale School of Medicine, New Haven, Connecticut.
20
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan.
21
Tel-Aviv Sourasky Medical Center (Ichilov), Tel Aviv, Israel.
22
Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
23
Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
24
VU University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands.
25
Huntsman Cancer Institute (University of Utah), Salt Lake City, Utah.
26
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
27
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania.
28
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
29
Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.
30
Novartis Pharma AG, Basel, Switzerland.
31
Memorial Sloan Kettering Cancer Center, New York, New York. bajorind@mskcc.org.
#
Contributed equally

Abstract

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.

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center