Reno, Nevada (UroToday.com) -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase 2 randomized, open-label THOR-2 study evaluating BALVERSA® versus investigator choice of intravesical chemotherapy in patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) and select fibroblast growth factor receptor (FGFR) alterations which recurred after Bacillus Calmette-Guérin (BCG) therapy. Data from Cohort 1 of the study were featured today in a Proffered Paper Late-Breaking Session (Abstract #LBA102) at the European Society for Medical Oncology (ESMO) 2023 Congress taking place October 20-24 in Madrid, Spain, and simultaneously published in Annals of Oncology.[i],[ii]
Of the 73 patients included in Cohort 1, 49 were randomized to BALVERSA® and 24 were randomized to chemotherapy. Oral erdafitinib reduced the risk of recurrence of disease or death by 72 percent compared with intravesical chemotherapy in patients with high-risk resected papillary Ta/T1 NMIBC harboring FGFR mutations or fusions with recurrence after BCG treatment and who refused or were ineligible for radical cystectomy.
With a median follow-up of 13.4 months at the data cutoff, median recurrence-free survival (RFS) was not met in patients who received BALVERSA® and was 11.6 months for patients who received chemotherapy (Hazard Ratio [HR]=0.28; 95 percent Confidence Interval [CI], 0.13-0.62; nominal p=0.0008). The six-month RFS in patients randomized to BALVERSA® was 96 percent compared to 73 percent in those assigned to chemotherapy. The 12-month RFS in patients assigned to BALVERSA® was 77 percent compared to 41 percent in patients who received chemotherapy.
Grade 3 or 4 serious treatment-related adverse events (TRAEs) were observed in fifteen patients (31 percent) who received BALVERSA® and one patient (4 percent) randomized to chemotherapy. Fourteen patients (29 percent) assigned to BALVERSA® and zero patients who received intravesical chemotherapy had TRAEs that lead to discontinuation of treatment. Central serous retinopathy occurred in 19 patients (39 percent) who received BALVERSA® and resolved in 11 patients (58 percent).
“Patients with NMIBC who experience disease recurrence after BCG treatment have limited treatment options, and those eligible patients with FGFR alterations who received erdafitinib in the THOR-2 trial had far fewer recurrences against patients treated by the current standard of care," said James W.F. Catto*, Ph.D., Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK and presenting author of the study. “Our findings underscore the importance of detecting certain genetic biomarkers to identify patients who may benefit from treatment with a targeted therapy like erdafitinib."“Janssen’s ongoing development of BALVERSA reinforces our commitment to bringing targeted, precision medicines to patients with FGFR-driven bladder cancer,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “These results support the importance of testing for FGFR in early-stage bladder cancer and potential benefit with BALVERSA in patients with high-risk non-muscle-invasive bladder cancer where disease progression and poor outcomes are common.”
References:
[i] Catto J, et al. THOR-2 Cohort 1: Results of Erdafitinib (Erda) vs Intravesical Chemotherapy (Chemo) in Patients (Pts) With High-Risk Non–Muscle-Invasive Bladder Cancer (HR NMIBC) With Select Fibroblast Growth Factor Receptor Alterations (FGFRalt) Who Received Prior Bacillus Calmette-Guérin (BCG) Treatment. 2023 European Society for Medical Oncology Congress. Presented at the 2023 European Society for Medical Oncology Congress.
[ii] Catto J, et al. Erdafitinib in BCG-treated high-risk non-muscle invasive bladder cancer. Annals of Oncology. Published online: October 20, 2023. Available at: https://www.annalsofoncology.org/article/S0923-7534(23)04015-2/fulltext
Source: Janssen Global Services, LLC. (2023). Results from Phase 2 THOR-2 Study Show Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations Treated with BALVERSA® (erdafitinib) Vs Chemotherapy [Press release]. https://www.janssen.com/results-phase-2-thor-2-study-show-improved-rates-recurrence-free-survival-patients-high-risk-non.
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ESMO 2023: THOR-2: Results of Erdafitinib vs Intravesical Chemotherapy for High-Risk Non Muscle Invasive Bladder Cancer with Select FGFR Alterations Who Received Prior BCG Treatment