Erdafitinib demonstrates improved responses in FGFR-altered advanced urinary tract cancers (36% lower death risk than platinum chemo)

Medical Xpress / Univ of Texas M. D. Anderson Cancer Center / New Eng Jrnl of Med / Annals of Oncol ^ | Oct. 23, 2023 | Yohann Loriot et al / A.O. Siefker-Radtke et al

[ConservativeMind]

Targeted treatment with the fibroblast growth factor receptor (FGFR) inhibitor erdafitinib improved responses and overall survival compared to standard chemotherapy for patients with metastatic urothelial cancers with FGFR alterations. Results from the Phase III THOR trial were reported.

Genetic changes in FGFR are present in approximately 20% of patients with metastatic bladder cancer and up to 35% of patients with other urothelial cancers, including renal pelvis and ureter cancers. In 2019, erdafitinib was approved by the Food and Drug Administration.

The ongoing randomized THOR trial, conducted at 121 sites in 23 countries, evaluated the efficacy and safety of erdafitinib in patients with metastatic urothelial carcinoma and selected FGFR gene alterations. Patients were screened for the presence of FGFR gene alterations and assigned to two cohorts based on prior treatment with platinum-containing chemotherapy or immune checkpoint inhibitors.

The median overall survival (OS) was 12.1 months and 7.8 months, respectively, corresponding to a 36% lower risk of death for those treated with erdafitinib. The OS benefit was seen across subgroups.

Further, erdafitinib achieved a median progression-free survival of six months compared to just three months for chemotherapy. Nearly half (46%) of patients treated with erdafitinib had an objective response, meaning their tumors shrank, while just 12% on the chemotherapy arm had an objective response.

In the second cohort, 351 patients who had not received prior immunotherapy were randomized to receive either erdafitinib or pembrolizumab (anti-PD-1). There was no statistically significant difference in OS between the treatment arms, as erdafitinib had similar survival compared to immunotherapy in patients who received prior pembrolizumab.

Erdafitinib did achieve a median progression-free survival of 4.4 months compared to 2.7 months for pembrolizumab. Further, 40% of patients treated with erdafitinib had an objective response, while just 21.6% on the pembrolizumab arm had an objective response.

[ConservativeMind]

This is available today.

46% of tumors in the first study, shrank. However, in the second study, the duration of response rates were quite reduced over pembrolizumab, despite a greater response rate of 40% versus 21.6%.

[ConservativeMind]

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