RE:RE:RE:RE:RE:RE:RE:RE:CG Oncology phase 3 results impossible for TLT to beat?DJDawg wrote: High success rate is tricky. Many patients have been through the long series of BCG instillations and then had that fail. Now to be offered another long series (weekly x 6 weeks, then 3 more at 3m, 6m, 9m and 12m) is a lot to take in. Many patients don't actually live near a urology care centre so there is lots of commuting to consider.
In phase 1b, Ruvidar was used on 3 patients. 2 of them had a total of 5 tumour sites on bladder wall and were cured after one treatment (cured in as far as not recurrence when followed for 18 m afterwards). That is a powerful thing. No oncologist on the planet would consider one dose of an immune agent as able to do anything at all. Hence the 18 treatments for most of them, in the first year.
I hope that whoever is writing up these applications for TLT can highlight that all the rest do not show a durable response when you stop the constant instillations. For the CG oncology data they have not resported outcomes on any patients who has gone beyond 3m from last treatment.
All the agents that have reported so far show significant fall off after 450 days. N-803 combined with BCG has a CR of 24-30% by 24m with ongoing fall off. . Compared to the touted 70% initial CR.
If they could get GBM going then that is two things in the pipeline as another selling point.
The lease your life model appears to be the popular girl at the party. How else can you explain the FDA and uro-oncology community's love affair with the model and the enormous valuation disparity?
Aside from all the challenges patients experience in this wack-a-mole never ending treatment model, just how does a lease your life model get a pass with insurers?
The issue is time and patience.Theralase is the extremely under-appreciated tortoise in the race. LT durability and an appropriate pricing scheme once commercialized should eventually win over both the doctors and most definitely insurers. From this broader perspective and considering the drawbacks of all current competing protocols, I still think gem/doce is the protocol to beat in terms of LT durable response.
https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.6_suppl.573