Dr. Pierre Frères, a medical oncologist at CHU de Liège, provided an overview of the genitourinary tumors session at ESMO2023.
In the Phase 3 THOR-2 study, erdafitinib was compared to pembrolizumab in patients with metastatic urothelial carcinoma (mUC) and specific FGFR alterations. No significant difference in overall survival was observed, and both groups exhibited similar hazard ratios. While erdafitinib demonstrated a superior response rate and progression-free survival, it also resulted in higher toxicity. FGFR inhibitors reaffirmed their efficacy in this patient subgroup. However, the question persists regarding the optimal sequencing of FGFR inhibitors with immunotherapy, whether they should be administered before or after immunotherapy.
Erdafitinib was also investigated in the THOR2 study for high-risk non-muscle-invasive bladder cancer (HR NMIBC) patients who had previously undergone bacillus Calmette-Guérin (BCG) treatment. Patients were selected based on specific fibroblast growth factor receptor alterations (FGFRALT). Those ineligible for or unwilling to undergo radical cystectomy were assigned to either erdafitinib or intravesical chemotherapy. Despite the premature closure of the trial, the primary endpoint, recurrence-free survival, was met. Erdafitinib could potentially have a role in this disease, pending availability of long-term data, possibly limited to local therapy.
Finally, the results from a Phase 1 trial involving a Double Antibody Drug (DAD) conjugate in mUC were presented. This trial marked the first instance of combining antibody treatment with sacituzumab govitecan (SG) and enfortumab vedotin (EV) simultaneously, rather than sequentially. The trial determined the maximum tolerated dose of the combination products and their associated toxicity profile. While the combination therapy exhibited a remarkably high response rate, it also displayed significant toxicity. Consequently, the authors proposed advancing to a Phase 2 trial, exploring a triplet therapy where both antibodies are combined with immunotherapy.
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