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Thomas Flaig, MD


ASCO 2023: Final NORSE Trial Results on Erdafitinib Plus Cetrelimab in Metastatic Urothelial Carcinoma

By: Celeste L. Dixon
Posted: Monday, June 12, 2023

The results of the 87-patient, randomized phase II NORSE study indicated that erdafitinib plus cetrelimab may fill an unmet need in the first-line treatment of cisplatin-ineligible patients with FGFR-altered metastatic urothelial carcinoma. The combination demonstrated clinically meaningful activity, with no additive toxicity beyond the known safety profiles of erdafitinib, an FGFR inhibitor, and cetrelimab, an anti–PD-1 monoclonal antibody. The combination yielded a better overall response rate than did erdafitinib alone, reported Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4504).

The combination arm included 44 patients (median age, 69; visceral metastases in 60.0%), whereas the single-agent arm included 43 patients (median age, 72; visceral metastases in 63.6%). After a median follow-up of 14.2 months, the overall response rate with the combination therapy was 54.5%, with six (13.6%) complete responses and a 12-month overall survival rate of 68%. A total of 11 of 24 responses were ongoing. In comparison, in the single-agent arm, the overall response rate was 44.2%, with one complete response and a 12-month overall survival rate of 56%. A total of 9 of 19 responses were ongoing.

Treatment-related adverse events of grade 3 or higher occurred at about the same rate in both cohorts (45.5% with the combination vs. 46.5% with the single agent). The most frequent treatment-emergent adverse events of any grade were hyperphosphatemia, stomatitis, and diarrhea.

The team noted that, additionally, four patients in each arm had PD-L1–positive disease. Three of the four patients in the combination arm responded to the drugs, but none of the four patients in the erdafitinib-alone arm did so.

Disclosure: The study authors’ disclosure information can be found at

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