Erdafitinib Plus Cetrelimab Elicits Durable Responses in Metastatic Urothelial Carcinoma

Erdafitinib alone or in combination with cetrelimab has shown activity in patients with FGFR-altered metastatic urothelial carcinoma who are ineligible for cisplatin, according to research presented at the ASCO Annual Meeting 2023.

The durable complete responses (CRs) seen with erdafitinib and cetrelimab support further study of the combination, said study presenter Arlene O. Siefker-Radtke, MD, of the University of Texas MD Anderson Cancer Center in Houston.

These findings come from the phase 2 NORSE study (ClinicalTrials.gov Identifier: NCT03473743), which included 89 patients with metastatic urothelial carcinoma. All patients were ineligible for cisplatin, had susceptible FGFR alterations, had measurable disease, and had received no prior systemic therapy.

The patients were randomly assigned to receive either erdafitinib plus cetrelimab (n=45) or erdafitinib alone (n=44). Baseline characteristics were generally balanced between the treatment arms.

The objective response rate was 54.5% in the erdafitinib-cetrelimab arm and 44.2% in the erdafitinib monotherapy arm. Six patients in the combination arm and 1 patient in the monotherapy arm had a CR.

The median duration of response was 11.1 months for the combination arm and 9.7 months for the monotherapy arm. The disease control rate was 88.4% and 79.5%, respectively.

The median progression-free survival was 11.0 months in the combination arm and 5.6 months in the monotherapy arm. The median overall survival was 20.8 months and 16.2 months, respectively. The 12-month overall survival rates were 68% and 56%, respectively. 

The most frequent treatment-related adverse events (AEs) of any grade in the combination and monotherapy arms were hyperphosphatemia (68.2% and 83.7%, respectively) and stomatitis (56.8% and 69.8%). Grade 3-4 treatment-related AEs occurred in 45.5% of patients in the combination arm and 46.5% of those in the monotherapy arm.

“Overall, these results support the use of erdafitinib in metastatic urothelial carcinoma patients with FGFR alterations,” Dr Siefker-Radtke concluded.

Disclosures: This research was supported by Janssen Research & Development. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Siefker-Radtke AO, Powles T, Moreno V, et al. Erdafitinib (ERDA) vs ERDA plus cetrelimab (ERDA+CET) for patients (pts) with metastatic urothelial carcinoma (mUC) and fibroblast growth factor receptor alterations (FGFRa): Final results from the phase 2 Norse study. ASCO 2023. June 2-6, 2023. Abstract 4504.

This article originally appeared on Cancer Therapy Advisor