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ESMO 2021: Erdafitinib Plus Cetrelimab in Advanced Urothelial Carcinoma With FGFR Alterations

By: Sarah Campen, PharmD
Posted: Friday, September 24, 2021

The combination of the FGFR inhibitor erdafitinib and the monoclonal antibody cetrelimab resulted in clinically meaningful responses in patients with metastatic urothelial carcinoma and fibroblast growth factor receptor (FGFR) alterations who are not eligible for cisplatin, according to Thomas B. Powles, MD, of Barts Cancer Institute, London, and colleagues. The first results of the phase II NORSE study, presented during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract LBA27), also revealed that safety for the treatment combination was consistent with erdafitinib monotherapy. Enrollment in the NORSE trial is ongoing.

To date, this study has enrolled 53 patients with cisplatin-ineligible metastatic or locally advanced urothelial carcinoma with FGFR alterations to receive first-line therapy with either erdafitinib orally at 8 mg daily (n = 26), with pharmacodynamically guided uptitration to 9 mg, or erdafitinib at 8 mg daily plus cetrelimab at 240 mg intravenously every 2 weeks at cycles 1 to 4 and 480 mg every 4 weeks thereafter (n = 27). Visceral metastases were present in 54% and 52% of patients in the monotherapy and combination-therapy arms, respectively.

The overall response rate in evaluable patients was 33% with erdafitinib monotherapy (n = 18) compared with 68% with the combination therapy (n = 19). Complete responses were confirmed in one versus four patients, respectively. As for safety, the most frequent treatment-emergent adverse events in the monotherapy and combination-therapy arms were hyperphosphatemia (58% vs. 58%), stomatitis (63% vs. 54%), and diarrhea (50% vs. 42%).

Disclosure: For full disclosures of the study authors, visit

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