Combat Medical, a medical device company for cancer therapeutics, has produced data showing 68% high-grade recurrence-free survival (HG-RFS) at 12 months in patients with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer (NMIBC) after hyperthermic intravesical chemotherapy with mitomycin C.
The findings of the retrospective study of 150 patients support HIVEC as a bladder-preserving treatment option for patients facing radical cystectomy.
“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,” said Combat Medical CEO Edward Bruce-White.
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.
“Treatment pathways for patients with BCG-unresponsive NMIBC are clinically challenging, particularly when radical cystectomy is not an appropriate option,” said Professor Joost Boormans, head of the department of Urology at Erasmus Medical Centre. “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.”
The Combat bladder recirculation system (BRS), developed using the Company’s patented hyperthermic platform technology, delivers HIVEC at precisely controlled temperatures to enhance the cytotoxic effect of treatment while offering a bladder-preserving alternative.
The Erasmus MC conducted the retrospective study. It 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.
Key findings include:
- 150 BCG Unresponsive patients
- 68% HG-RFS at 12 months (all patients)
- 83% HG-RFS at 12 months (papillary only patients)
- 61% HG-RFS at 12 months (CIS only patients)
- 56% complete response at 6 months in patients with CIS; response maintained at 12 months in 68% of responders
- 92% progression-free survival at 12 months
- 21-month median follow up
- Well tolerated, 12% Adverse Events report, with 99% grade 1 and 2
Dr Yoran Tomassen from the Erasmus Medical Centre presented the data at the 18th European Multidisciplinary Congress on Urological Cancers.
