RE:RE:RE:RE:RE:New Online Ad from Bladder Cancer Advocacy NetworkThanks Slayer,
I agree this wont happen overnight, still, I think because we are talking about elderly, mostly, patients here, we will eventually get a healthy % of Docs reccomending this as an experimental option.
CancerSlayer wrote: Rumpl3StiltSkin wrote: Eoganacht wrote: It would be great to see a trial of TLD1433 as a first-line treatment of NMIBC after TURBT. Hopefully it would perform better than the 60% of patients who are responsive to BCG. It would certainly outdo BCG in patient friendliness. Maybe one day...
CancerSlayer wrote: Eoganacht wrote: There is a need for more options in non-muscle invasive bladder cancer (NMIBC) when BCG fails Bacillus Calmette-Gurin (BCG) has remained the first-line standard of care for more than 40 years
- Though BCG can be initially effective in the first-line treatment of high-risk NMIBC, BCG will fail in more than 40% of patients
- When BCG fails, high-risk patients are more likely to progress to muscle-invasive diseases, bringing them one step closer to life-altering radical cystectomy
"The limited number of patients studied in these [therapeutic] trials, the modest and limited recurrence-free survival with treatment, and the lack of data demonstrating an improvement in progression-free survival illustrate the need for novel agents.
– AUA/SUO Guideline"
Thanks Eoganacht...& unfortunately, patients will have to continue to contend with an ongoing BCG shortage that could last for at least several more years. I believe Merck is planning to have a new manufacturing facility completed in Durham, NC by ~2026/2027.
It's boggling to me that in this modern era of Western technology & proclaimed humanity by the West that we can even be in such a position of limited availability....to a "first-line" treatment for a relatively common & devastating cancer. Such a limit gets compounded by the fact that many patients may also be subject to a need for splitting of doses (1/2 to 1/3 dose)...all of this adding even more potential insult to injury & the end result being an increase in radical cystectomies & morbidity/mortality....all imo. Interestingly, a multicenter clinical trial (NIMBUS) was recently conducted to assess the efficacy of a reduced number of instillations vs SOC. Not surprisingly, after an interim analysis, the trial had to be halted when inferior efficacy was noted in the reduced schedule arm.
Rising global demand & limited BCG supply/efficacy are here to stay for the foreseeable future...should bode well for the future of TLD-1433 imho.
Just my opinion,
IF this Phase 2 gets as many as 50/60 patients treated before a halt, again IMO. I think the CR %s will be up into the 70s/80s. Wont many Docs simply prescribe this as first line SoC off label?
Many less treatments for the patient, easy to sell to them if it is more effective as well. ;-)
Hi Rumpl....there is no law or medical community rule that requires doctors to always begin treatment with the first-line option. Considering recent advances made in personalized medicine & the fact that first-line therapies can have their limitations/drawbacks (low efficacy, high cost, limited drug availability, increased side effects, etc.), demand for other suitable options always exists. A doc certainly has the legal freedom to use a "labeled" 2nd-line treatment as a 1st-line option. However, I see 4 reasons why docs would hesitate: 1). Many docs simply want to see supportive 1st-line data from a head-to-head clinical trial. 2). Docs may generally be less inclined to use a novel first-in-class treatment or form of treatment they're less familiar with. 3). Docs generally want to reduce lawsuit exposure risk. 4). I suspect many insurance carriers wouldn't pay for a 2nd-line treatment when used as a 1st-line...
The two options moving forward would be to perform a head-to-head trial with SOC, or simply wait for FDA approval as a 2nd-line, & after an extended period of treatment success/experience, request approval from the FDA to expand the labeling as a 1st-line...& perhaps even as a 1st or 2nd-line treatment for other forms of cancer. The latter would be a good path to take imo, while they pursue expanding their ACT for other indications (GBM, NSCLC) = more bang for the buck imo. Good luck.