In a phase II study (NORSE) reported in the Journal of Clinical Oncology, Loriot et al found that both erdafitinib monotherapy and the combination of erdafitinib and cetrelimab were active as first-line treatment in cisplatin-ineligible patients with metastatic urothelial carcinoma with FGFR alterations.
Study Details
In the noncomparative multicenter trial, 87 patients were randomly assigned between October 2019 and March 2022 to receive erdafitinib at 8 mg once daily (with pharmacodynamically guided uptitration to 9 mg once daily) (n = 43) or erdafitinib at 8 mg once daily plus cetrelimab at 240 mg once every 2 weeks during cycles 1 to 4 and at 480 mg once every 4 weeks thereafter (n = 44). The primary endpoint was investigator-assessed objective response rate.
Key Findings
In the erdafitinib monotherapy group, the objective response rate was 44.2% (95% confidence interval [CI] = 29.1%–60.1%), with complete response in one patient. Median duration of response was 9.7 months (95% CI = 4.6 months to not estimable). Median overall survival was 16.2 months (95% CI = 8.3 months to not estimable).
In the erdafitinib plus cetrelimab group, the objective response rate was 54.5% (95% CI = 38.8%–69.6%), with complete response in six patients. Median duration of response was 11.1 months (95% CI = 8.8 months to not estimable). Median overall survival was 20.8 months (95% CI = 12.0 months to not estimable).
The most common treatment-related adverse events of any grade in the erdafitinib and erdafitinib plus cetrelimab groups were hyperphosphatemia (83.7% and 68.2%), stomatitis (69.8% and 56.8%), and dry mouth (37.2% and 56.8%). Grade ≥ 3 treatment-related adverse events occurred in 46.5% and 45.5% of patients, respectively, with the most common being stomatitis (16.3% and 9.1%). One death considered related to study treatment occurred in the combination group, due to respiratory failure.
The investigators concluded: “First-line erdafitinib monotherapy and erdafitinib plus cetrelimab demonstrated antitumor activity and a manageable safety profile in cisplatin-ineligible patients with [metastatic urothelial carcinoma].”
Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, Houston, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by Johnson & Johnson. For full disclosures of the study authors, visit ascopubs.org.
