Erdafitinib Prolonged Overall Survival Among Patients With FGFR-Altered Metastatic Urothelial Carcinoma Treated With Checkpoint Inhibitors

According to results from the phase 3 THOR trial, erdafitinib significantly prolonged the overall survival (OS) among patients with metastatic urothelial carcinoma and FGFR alterations who had previously received anti–PD-1/L1 treatment, when compared with chemotherapy.

Yohann Loriot, MD, PhD, Gustave Roussy, Villejuif, France, and coauthors wrote, “Erdafitinib is a pan-fibrolast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-based chemotherapy.” The efficacy of erdafitinib among patients with FGFR-altered metastatic urothelial carcinoma who have progression during or following treatment with anti–PD-1/L1 therapies is unknown.

In the THOR trial, 266 patients in this patient population who had progressed following 1 to 2 lines of treatment that included an anti-PD-1 or anti-PD-L1 agent were randomized on a 1-to-1 basis. Those in the erdafitinib arm (n = 136) received 8 mg erdafinitib once daily. Those in the chemotherapy arm (n = 130) received investigator’s choice of either docetaxel or vinflunine. The primary end point of this study was overall survival (OS).

The median OS in the erdafitinib arm was 12.1 months compared with 7.8 months in the chemotherapy arm (hazard ratio [HR] for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P = .005). The median progression-free survival (PFS) was also longer in the erdafitinib arm vs the chemotherapy arm (5.6 months vs 2.7 months, respectively; HR for progression or death, 0.58; 95% CI, 0.44 to 0.78; P < .001). The incidence of grade 3 or 4 treatment-related adverse events was 45.9% in the erdafitinib arm and 46.4% in the chemotherapy arm. Those treatment-related adverse events which led to death were less common in the erdaftinib arm (0.7%) than the chemotherapy arm (5.43%).

Dr Loriot et al concluded, “Erdaftinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and FGFR alterations after previous anti–PD-L1 or anti–PD-L1 treatment.”

Source:

Loriot Y, Matsubara N, Park SH, et al. Erdafitinib or chemotherapy in advanced or metastatic urothelial carcinoma. N Eng J Med. Published online November 23, 2023. doi:10.1056/NEJMoa2308849