Combat Medical has announced new data showing 68% high-grade recurrence-free survival (HG-RFS) at 12 months in patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) after hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C.
The company said the findings of the retrospective study of 150 patients further support HIVEC as a bladder-preserving treatment option for patients facing radical cystectomy.
The data were presented at the 18th European Multidisciplinary Congress on Urological Cancers (EMUC) by Yoran Tomassen from the Erasmus Medical Center (Erasmus MC).
Radical cystectomy is the recommended treatment for patients with BCG-unresponsive NMIBC. However, many patients are medically unfit for surgery or decline the procedure due to its complexity, high risk of complications and life-altering impact post-surgery. The Combat bladder recirculation system (BRS), developed using the company’s hyperthermic platform technology, delivers HIVEC at precisely controlled temperatures to enhance the cytotoxic effect of treatment while offering a bladder-preserving alternative.
The study, conducted by the Erasmus MC, evaluated patients with BCG-unresponsive NMIBC, who received HIVEC with mitomycin C using the Combat BRS at the Erasmus MC and Amphia hospital in The Netherlands between 2015 and 2022.
Edward Bruce-White, chief executive officer of Combat Medical, said: “This study demonstrates HIVEC’s efficacy and tolerability in patients with BCG-unresponsive NMIBC and provides real-world evidence to support the potential of HIVEC as a highly effective bladder-preserving treatment option for patients who are unwilling or unfit to undergo radical cystectomy. Confirmation in our prospective HIVEC HEAT trial will establish HIVEC as a leading treatment option in this challenging patient population.”
Joost Boormans, head of the Department of Urology at Erasmus Medical Center, said: “Treatment pathways for patients with BCG-unresponsive NMIBC are clinically challenging, particularly when radical cystectomy is not an appropriate option. Through this study, we have demonstrated the ability of HIVEC to achieve meaningful cancer control while maintaining a favourable safety profile, supporting its potential as an effective bladder-preserving treatment for routine clinical practice.”