Results from Phase 2 THOR-2 Study Showed 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 Erdafitinib Versus Chemotherapy
October 23, 2023 – Clinical Trials – Janssen, clinical trials, oncology
Data from Cohort 1 of the phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy
21 October 2023 — Beerse, Belgium — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from Cohort 1 of the phase 2 randomised, open-label THOR-2 study evaluating erdafitinib 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. The data were featured today in a Proffered Paper Late-Breaking Session (Abstract #LBA102) at the European Society for Medical Oncology (ESMO) 2023 Congress taking place 20-24 October in Madrid, Spain. The study results are simultaneously published in Annals of Oncology.
“Treatment options are limited for patients with high-risk non-invasive bladder cancer with disease recurrence after Bacillus Calmette-Guérin therapy and who are ineligible or refuse radical cystectomy, the current standard of care,” said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag GmbH. “Patients are at the forefront of all that we do, and we are committed to following the science to explore new options that may provide improved care in areas of high unmet need, such as this.”
Of the 73 patients included in Cohort 1, 49 were randomised to erdafitinib and 24 were randomised to chemotherapy. Oral erdafitinib reduced the risk of recurrence of disease or death by 72% compared with intravesical chemotherapy in patients with high-risk resected papillary Ta/T1 NMIBC harbouring 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 cut-off, median recurrence-free survival (RFS) was not met in patients who received erdafitinib and was 11.6 months for patients who received chemotherapy (Hazard Ratio [HR] 0.28; 95% Confidence Interval [CI], 0.1-0.6; P=0.0008).1 The six- and twelve-month RFS rates (95% CI) were 96% (83.7-98.9) and 77% (60.0-87.4) for erdafitinib versus 73% (50.1-87.1) and 41% (18.9-61.7) for chemotherapy, respectively.
Grade 3 or 4 serious treatment-related adverse events (TRAEs) were observed in 15 patients (31%) who received erdafitinib and one patient (4%) randomised to chemotherapy. Fourteen patients (29%) assigned to erdafitinib and zero patients who received intravesical chemotherapy had TRAEs that lead to discontinuation of treatment. Central serous retinopathy occurred in 19 patients (39%) who received erdafitinib and resolved in 11 patients (58%).
“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, PhD, 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 erdafitinib reinforces our commitment to bringing targeted, precision medicines to patients with FGFR-driven bladder cancer,” said Kiran Patel, MD, vice president, Clinical Development, Solid Tumours, Janssen Research & Development. “These results support the importance of testing for FGFR in early-stage bladder cancer and potential benefit with erdafitinib in patients with high-risk non-muscle-invasive bladder cancer where disease progression and poor outcomes are common.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension and Retina. Learn more at www.janssen.com/emea.
