RE:RE:RE:RE:Exploring NMIBC Options in the face of BCG Shortageswildbird1 wrote: Benedictus, Gem/Doce is definitively not the current standard of care to beat for TLT-Ruvidar.
Gemcitabine/Docetaxel are both chemotherapy drug, that come with a ton of side effects including death(the list of side effects is to long to enumarate).
Because of side effects chemotherapy drug are recommanded by doctors only as a last resort(especially for older patients prone to side effects).
Gemcitabine/Docetaxel are the perfect exemple why the FDA is looking for treatments that are 100% safe with almost no side effects like TLT-Ruvidar(remember safety(+ side effects) is the third endpoint that the FDA take into account when evaluating any cancer treatment).
Worth repeating TLT-Ruvidar is 100% safe.
TLT-Ruvidar is still way ahead of anything out there including Keytruda, Adstiladrin, N803+BCG and GEm/Doce.
The superiority of TLT-Ruvidar over anything out there is a derisking factors for insiders & accredited investors, given time financing will be fine.
Benedictus wrote: 99942Apophis wrote: Benedictus wrote: There's been a lot of solid analysis on this board recently discussing where a possibly approved Ruvidar could land in the competition for SoC in BCG-unresponsive NMIBC. I was reviewing a few articles on the BCG lack of availability along with the current workarounds and found this article, which I think is a relevant primer for discussion here by some of the brighter more scientific minds than mine. I was disappointed that Ruvidar wasn't even mentioned in the article considering that both members of Therelase's scientific advisory board were either quoted or mentioned, although I suppose it does fit right into Ruvidar's underdog role. I'd appreciate any thoughtful analysis on the many topics and relevant links this article provides as it relates to Ruvidar's potential in a commercial market where doctors are looking for the best patient options and outcomes.
https://guoncologynow.com/post/exploring-nmibc-options-in-the-face-of-bcg-shortages-failure
Benedictus, rather than quote the merits of one drug over another, I would point out that all the drugs and treatments within that article have been approved. Ruvidar currently in trial has great CR & durability, however hasn't been approved yet. This of course takes us off the discussion until it hits official recognition by way of BTD or AA which will be the pat on the back that we need. Once some official approval is given safety, no adverse side affects, durability and CR percent will be discussed. Theralase's day is at hand.
Actually quite a few non-approved drugs were discussed in the article, so you apparently read it with very little interest. Either way, the point of posting was to generate some discussion (and allay some of my concerns) about how much the commercial landscape for the indication Theralase is pursuing continues to evolve at faster clip, I might add, than Theralase's 2 or 3 new enrollees per quarter. While BTD and AA are certainly key milestones enabling an expeditious path for Ruvidar to enter the commercial fray, we must also try to understand its competitive viability and where ruvidar could fit amongst the current and growing options doctors have for their patients and that insurance companies will cover.
Chief among my concerns is the FDA's altering stance toward non-FDA approved BCG strains and the ongoing clinical trial comparing efficacy of BCG strains with results due by end of 24. On the surface, it seems this development could alter Anktiva's potential patient base by a very wide margin. Wild speculation or a valid concern wrt Theralase's potential commercial market size? Not FUD or bashing but a sincere open question for discussion and debate...
In terms of current BCG-unresponsive treatment, according to this article, the preferred regimen is sequential gerncitabine/docetaxel. I have not been on this board that long, so perhaps I've missed prior discussions about this treament regimen. Am I missing something or isn't Gem/Doce the current standard of care to beat?? Again open for discussion. Here's the results:
https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.6_suppl.573
Wild, I appreciate your thoughts. I am here to understand the actual market opportunity for ruvidar because I believe the BTD and AA hurdles could drop within a year or so, enabling ruvidar to be a commercially viable option. So my questions are to probe around what the commercial playing field looks like and what could be Theralase's cut of the estimated $1.1 - $1.5B annual market. While I understand that ruvidar may be safer and much better tolerated than Gem/Doce, the durability of this established protocol should not be so quickly dismissed. The survival rates are higher than I would have expected. So, it appears Gem/Doce is a known protocol that doctors are comfortable with, has very impressive survival rates but is grueling on the patients and more tolerable procedures are being sought after. Is that your take?
Conclusions: Intravesical Gem/Doce for high-risk NMIBC after BCG failure offers long-term efficacy and substantial durability of response with a high likelihood of bladder preservation at five years after induction. Future prospective trials assessing Gem/Doce are warranted.
| Survival Outcome | 1 Year | 2 Years | 5 Years |
| Overall HG-RFS | 60% | 51% | 31% |
| BCG unresponsive HG-RFS | 67% | 53% | 33% |
| PFS | 86% | 79% | 68% |
| CFS | 89% | 86% | 75% |
| CSS | 99% | 97% | 91% |
| OS | 96% | 87% | 64% |