Theralase Technologies Inc. V.TLT

Politics Aside

[CancerSlayer]

BCG has a failure rate of up to 40% for high-grade NMIBC.  Based on which study you look at, add another ~7 to 20% who are considered BCG intolerant (I.e. had to discontinue BCG treatment due to treatment-related morbidity/toxicity).  Additionally, there was an overall 15-40% noncompliance rate noted after 1 year of BCG treatment based on two international studies done in the past 8 years.  Even though the interim data from ImmunityBio's N-803 + BCG combo trials show promise (for BCG-unresponsive & BCG-naive patients), such a protocol can't avoid the reality of BCG intolerance & the requisite treatment-intensive protocol that is so patient "unfriendly" in terms of quality of life/personal-social impact, which further increases the likelihood of treatment noncompliance....all imo.

Combine the above with the reality of the ongoing BCG shortage, high BCG/combo treatment costs & low efficacy rates of the two currently approved drugs, there should be significant opportunities for emerging novel treatments to capture a good portion of the market imo.

A journal excerpt re: BCG toxicity...

Efficacy and toxicity of intravesical Bacillus Calmette-Gurin therapy in elderly patients with non-muscle-invasive bladder cancer

Matsuoka, Yuki; Taoka, Rikiya^∗; Kohashiguchi, Kana; Tohi, Yoichiro; Miyauchi, Yasuyuki; Kato, Takuma; Tsunemori, Hiroyuki; Ueda, Nobufumi; Sugimoto, Mikio

Author Information 

Current Urology: March 2021 - Volume 15 - Issue 1 - p 16-21
 

"With regard to toxicity, Oddens et al.^[22] reported that the percentage of patients who discontinued BCG therapy due to toxicity was 17.9% for patients aged ≤60 years, 21.9% for patients aged 61–70 years, 22.9% for patients aged 71–75 years, and 16.4% for patients aged >75 years. In terms of systemic and local side effects, there was no significant difference between each age group. However, Heiner et al.^[23] reported that the complication rate for intravesical BCG was 17.6% for patients <70 years old and 48.6% for patients ≥70 years old. They concluded that BCG should be administered with caution in patients aged >70 years and should be avoided in patients aged >80 years."