Theralase Technologies Inc. V.TLT

New BCG-Unresponsive NMIBC Treatment Review Study

[Eoganacht]

European Urology Oncology

Available online 15 November 2024

David D’Andrea, Hugh Mostafid, Paolo Gontero, Shahrokh Shariat, Ashish Kamat, Alexandra Masson-Lecomte, Maximilian Burger, Morgan Rouprt

Unmet Need in Non–muscle-invasive Bladder Cancer Failing Bacillus Calmette-Gurin Therapy: A Systematic Review and Cost-effectiveness Analyses from the International Bladder Cancer Group

"A total of 57 studies published between 1998 and 2024, with 68 unique study arms and consisting of 2589 patients, were identified. The 3-mo overall response rate (ORR) across all studies, complete response rate (CRR) in concomitant carcinoma in situ (CIS) or CIS only disease, and recurrence-free rate (RFR) in papillary disease were estimated to be 52.4% (95% confidence interval [CI]: 45.4–59.2), 52.8% (95% CI: 42.9–62.6), and 26.4% (95% CI: 13.3–45.6), respectively. The 12-mo ORR, CRR, and RFR were estimated to be 78% (95% CI: 52.9–91.8), 27.8% (95% CI: 21.3–35.4), and 25.4% (95% CI: 18.2–34.2), respectively."



The study includes the toxicity events for all 4 BCG-Unresponsive NMIBC approved treatments. TLD1433 had better safety results (zero toxicity events) than all approved treatments.

	Grade 1-2	Grade 3	Grade 4	Grade 5
Valrubicin	19%	0%	0%	0%
Adstiladrin (NF)	8.3%	0%	0%	0%
Pembrolizumab	10.9%	2%	0%	0%
Anktiva (NAI)	39%	3.7%	1.2%	1.2%
TLD1433	0%	0%	0%	0%

[digitalstone]

Nice to see Dr.Ashish Kamat  involved in the above article! 

[StevenBirch]

Sounds to me like TLT, facing long odds and great difficulty, is...

[CancerSlayer]

Thanks Eoganacht....All factors considered (our current 12 month CR at ~27% & 12 month ORR at 71% across 68 patients, excellent safety profile & likely high cost-effectiveness...considering we are a one/two-and-done treatment), the future looks bright for this company. For me, this investment has always been about long-term benefits of investing in a promising business/science, not about

[wildbird1]

Thanks Eoganacht & CancerSlayer... In the article provided the conclusion is very interesting. 5.Conclusions... It said...'' Recent FDA -approved drugs, such as NF(Adstiladrin) and Pembrolizumab(keytruda), might be effectives alternatives to RC(radical cystectomy) in selected patients, achieving a good balance between cost, effectiveness, toxicity, and quality of life''

[skier59]

Where do you get a CR of 36% at 450 days for Rudvidar?? I see 27% at 360 days and 26% at 450 days as per the NR of October 7th.

[wildbird1]

Skier59, you are correct, I should have mentionned that the 36%CR, is the estimated CR% for 2026 (end of phase11 trial) as per the Corporate Presentation...March18,2024,Page 19... Theralase-Corporate-Presentation-03-19-2024.pdf