Efficacy of erdafitinib before or after enfortumab vedotin in FGFR3-altered advanced urothelial cancer: analysis of the UNITE collaborative study.
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Jiang Cindy Y, Hwang Hyunsoo, Epstein Ilana Y, Bakaloudi Dimitra Rafailia, Talukder Rafee, Taylor Amy K, Nizam Amanda, Jindal Tanya, Glover Michael J, Khaki Ali Raza, Barata Pedro C, Nguyen Charles B, Oh Eugene, Davis Nancy B, Mabey Hannah, Hoimes Christopher J, Evans Sean T, Abuqayas Bashar, Lemke Emily, Tsung Irene, Qiao Wei, Kilari Deepak, Zakharia Yousef, Bilen Mehmet A, Milowsky Matthew I, Shah Sumit A, Gupta Shilpa, Emamekhoo Hamid, Bellmunt Joaquim, Alva Ajjai S, Grivas Petros, Msaouel Pavlos, Koshkin Vadim S, Campbell Matthew T, Alhalabi Omar
Аннотация
METHODS: UNITE is a multi-institutional retrospective study of patients with LA/mUC treated with novel targeted agents. All patients with FGFR3 alterations treated with EV only, erdafitinib then EV (Erda->EV), and EV then erdafitinib (EV->Erda) were included. Sequential treatment with EV and Erda was not required. Primary endpoints were observed response rates (ORR) and progression-free survival (PFS); secondary endpoint was overall survival (OS).
RESULTS: We identified 83 patients with FGFR3 alterations and separated them into three cohorts: EV only (n = 44), Erda->EV (n = 24), and EV->Erda (n = 15). Most (72%) received ≥2 lines of therapy before erdafitinib (checkpoint inhibitor [87%], platinum-based chemotherapy [64%]). Median PFS with erdafitinib for EV-naïve cohort was 7.5 months and in EV-treated cohort 4.0 months (HR 0.78; 95% CI 0.35-1.7). ORR with erdafitinib for EV-naïve was 33% and EV-treated 31% (OR 1.1; 95% CI 0.29-4.1). Median PFS with EV for patients who were erdafitinib-naïve was 6 months and in erdafitinib-treated 5.3 months (HR 0.61; 95% CI 0.34-1.09). ORR with EV was 54% in erdafitinib-naïve cohort and 32% in erdafitinib-treated cohort (OR 2.5; 95% CI 0.87-6.3).
CONCLUSION: In patients with FGFR3-altered LA/mUC, erdafitinib is active pre- and post-EV. Outcomes with erdafitinib were consistent with clinical trial data generated prior to broader frontline use of EV. Findings are hypothesis-generating and given small sample size should be interpreted with caution.