RE:TLT and Competition Quite accurate but N-803 in combo with BCG was 82% CR at 3 months and 64% at 6 months out of 11 patients (23 CIS were treated but we only were given data on 11) . 9 out of 11 at 3 months and 7 at 6 months were CR and for Vicinium it is 17% at 12 months
What counts for the FDA is CR at 3 months, but mostly they want to see a durable response or 12 months data.
Keytruda 12 months CR of 19%
Vicinium 12 months at 17%
Instiladrin 12 months at 24%
N-803 plus BCG 12 months ???
TLD-1433 at 12 months???
Radachlorin PDT at 12 months 90% and 67% at 24
Photofrin PDT at 12 months 60%
Logically TLD-1433 should be somewhere between 60-90% using a way more Tumor selective drug and better dosimetry versus Photofrin and Radachlorin, so long as they don't undertreat and use maximum bladder volume. IMO time will tell. We will be able to have a good idea when we can evaluate how many of the patients who receive Optimized treatment are CR at 3 months, and 6 months, then we will easily extrapolate approximate 12 months CR IMO its coming just a matter of time.
Antidote wrote: Just thought I'd summarize where TLT sits among their competition in the NMIBC market. Please respond with any corrections or updates as this wasn't a deep dive. In 2017 the NMIBC market was $1.45B and it was estimated to grow about 8% each year which makes it about $2B in 2021 (in the 7 major markets of the world). https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-market TLT competitors: Keytruda, the only FDA approved competitor right now aside from BCG. Administered every 3 weeks for I don't know how long. 41% complete response (I assume after 3 months). 46% of those, so 18.9% overall, had CR at 12 months. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer Also, "The list price for each indicated dose of KEYTRUDA when given every 3 weeks is $9,869.94. The list price for each indicated dose of KEYTRUDA when given every 6 weeks is $19,739.88.*" https://www.keytruda.com/financial-support/ N-803. They were acquired about a month after getting Fast Track approval in 2017 for $290M. They do a combo of immunotherapy with BCG. So BCG might be a bottleneck for them. Their results were really good though. About 80% CR at 6 months (sample size of about 20 at the time). Last year they were given breakthrough status. https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.4561 Adstiladrin. Did a phase 3 trial. 53% CR at 3 months. 24% CR at 12 months. https://www.google.com/amp/s/www.urotoday.com/conference-highlights/suo-2019/suo-2019-bladder-cancer/117556-suo-2019-the-suo-ctc-phase-iii-adsiladrin-trial-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer.amp.html Valribicin. Is approved and has been for a while but they terminated a phase 3b trial and I can't find why. Also can find new info for it so maybe it's been phased out? https://en.m.wikipedia.org/wiki/Valrubicin https://clinicaltrials.gov/ct2/show/NCT01310803 Vicinium. Completed a phase 3 trial. FOR CIS patients 40% CR at 3 months. About 20% at 12 months. For papillary patients 71% 3 month CR and 37%12 month CR. About 2.5% had severe adverse events. https://www.google.com/amp/s/www.urotoday.com/conference-highlights/aua-2020/aua-2020-bladder-cancer/122653-aua-2020-phase-3-results-of-vicinium-in-bcg-unresponsive-non-muscle-invasive-bladder-cancer.amp.html CG0070. Interim phase 2 results from 2018 show 47% CR at 6 months. 30% at 12 months. There's probably a more updated report somewhere. https://www.google.com/amp/s/www.urotoday.com/conference-highlights/aua-2018/aua-2018-bladder-cancer/104383-aua-2018-cg0070-an-oncolytic-adenovirus-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer-12-month-interim-results-from-a-multicenter-phase-ii-trial.amp.html A little bit on TLTs trial: Regarding the 4 TLT patients who were removed from the study. All did not show any response after the first treatment and were then removed from the study (this criteria has been changed and these patients would now be eligible for a second treatment). Also, they under-treated all 12 patients in a range from approximately 30-150%. Even so, as of July 2020, 7 of them responded and 3 of those responded completely. The 1 remaining patient had negative cytology and "suspicious cystoscopy". As of Sept 2020, 3 patients with CR and 3 with Partial response. One of the patients must have gone from partial to no response or something. Anyways. If N-803 went for $290M and it was only half of the treatment, maybe TLT could be valued in that range with improved phase 2 results. $290M would be about $1.50/share or so. But if the other studies (GBM and NSCLC, vaccine) show promise, maybe its worth more. Thinking about investment risk The TLT CR is around 25% at 6 months with poor execution. By quickly estimating, Keytruda would have been about 33%, Adstiladrin 40%, Vicinium %32, CG0070 47%, and then N-803 at 80% (but needs BCG). So even without proper execution, TLT isnt very far off from most of the competition (with most data based off a single treatment). And I doubt the CR% will go down once we have more numbers with better optimization. So I dont feel like there is a ton of risk, even though the stock price is super unpredictable. Of course there is always risk with a trial and it could end suddenly, but I think theres a better chance of the CR being equal to or better than the competition. Although one big problem is TLT is looking like itll be the last to market. Buuut if the optimization bumps CR to something like 50% at 6 months wed be doing better than all except for N-803. I think the risk is acceptable for the potential success.