(UroToday.com) The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 16th, 2024 was host to a genitourinary cancers poster session. Dr. Yohann Loriot presented SOGUG-NEOWIN, an ongoing open label, multicenter phase II trial evaluating the efficacy and safety of both erdafitinib monotherapy and combination erdafitinib and cetrelimab as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) and Fibroblast Growth Factor Receptor (FGFR3) gene alterations.
The standard of care treatment for non-metastatic MIBC is neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy. However, many patients are cisplatin ineligible. Immune checkpoint inhibitors have changed the treatment landscape of metastatic urothelial cancer, including for those who are cisplatin-ineligible. Based on these results, immune checkpoint inhibitors are being explored in the neoadjuvant setting for resectable urothelial carcinoma, with preliminary data suggesting promising antitumor activity.
Erdafitinib is an FGFR inhibitor, which has shown efficacy in metastatic urothelial carcinoma patients with select FGFR2/3 mutations/fusions.1 Erdafitinib plus cetrelimab demonstrated clinically meaningful activity in patients with newly diagnosed FGFR-altered metastatic urothelial carcinoma in the phase II NORSE trial.2
SOGUG-NEOWIN will assess whether erdafitinib plus cetrelimab will improve the pathological complete response rate in patients with FGFR-positive MIBC candidates for radical cystectomy who are ineligible for or refuse neoadjuvant cisplatin-based therapy.
The study design is summarized below. Eligible patients are those with cT2-4aN0-1M0 urothelial carcinoma who test positive for FGFR mutations and are ineligible for or refuse neoadjuvant cisplatin. Ninety patients will be randomized to daily erdafitinib monotherapy versus combination erdafitinib + cetrelimab. The co-primary study endpoints are pathologic complete response and downstaging (i.e., <ypT2) rates.
The trial is currently approved in four countries (France, Italy, Spain, and UK). The first patient was enrolled in June 2024. This trial will be the first to systematically address whether erdafitinib +/- cetrelimab improves pathologic complete response in patients with FGFR-positive MIBC.
Presented by: Yohann Loriot, MD, PhD, Medical Oncology Department, Gustave Roussy, Université Paris-Saclay, Paris, France.
Written by: Rashid Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2024 European Society of Medical Oncology (ESMO) Annual Meeting, Barcelona, Spain, Fri, Sept 13 – Tues, Sept 17, 2024.
References:- Loriot Y, Matsubara N, Park SH, et al. Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2023; 389:1961-71.
- 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. J Clin Oncol. 2023; 41:Number 16_suppl.