I think efficacy means a good percentage of patients surviving beyond 12 months plus.
I looked at the figure 5 tnbc esmo graph again.
n=28
5 who received leron/ici were alive beyond 48 months.
2 received ici but were on low dose leron and didn't upregulate and died at about 4 and 5 months in.
Of the 21 patients who didn't receive the combo
16 died within about 10 months.
5 more died within 24 months
1 survived to 36 months
And I think about what the results might be if all of a 30 patient tnbc trial receive an ici at 60 days in.
And then I imagine what number of patients in say a 30 patient trial might survive beyond 12 months. And I dont want to say what I think the new trial would show.( I could make some wild predictions though) But i can't help but think a whole lot more than in the poster beat that 12 month mark.
So I then wonder, do we need these large one or two hundred patient trials to prove the combo extends life beyondany doubt?
I know the crc fda meeting was in August 2024 and fda approved the protocol in November 24.
Ignoring the eventual total participant number. Is it likely or semi likely we could hear this new tnbc trial has received approval to commence by around the end of Feb- end of March if everything goes well?
I'm kind of Ignoring what might happen with partnerships etc (and what other previous data might be included to get us over the hump ) and just trying to figure out how things might go as we move along.
I want as much data as we can get as quickly as we can get before we agree to any partnership, unless we are overwhelmed by the offer. I think every month that passes increases the value.
There are so many variables still. Anything could happen.
I looked at the figure 5 tnbc esmo graph again.
n=28
5 who received leron/ici were alive beyond 48 months.
2 received ici but were on low dose leron and didn't upregulate and died at about 4 and 5 months in.
Of the 21 patients who didn't receive the combo
16 died within about 10 months.
5 more died within 24 months
1 survived to 36 months
And I think about what the results might be if all of a 30 patient tnbc trial receive an ici at 60 days in.
And then I imagine what number of patients in say a 30 patient trial might survive beyond 12 months. And I dont want to say what I think the new trial would show.( I could make some wild predictions though) But i can't help but think a whole lot more than in the poster beat that 12 month mark.
So I then wonder, do we need these large one or two hundred patient trials to prove the combo extends life beyondany doubt?
I know the crc fda meeting was in August 2024 and fda approved the protocol in November 24.
Ignoring the eventual total participant number. Is it likely or semi likely we could hear this new tnbc trial has received approval to commence by around the end of Feb- end of March if everything goes well?
I'm kind of Ignoring what might happen with partnerships etc (and what other previous data might be included to get us over the hump ) and just trying to figure out how things might go as we move along.
I want as much data as we can get as quickly as we can get before we agree to any partnership, unless we are overwhelmed by the offer. I think every month that passes increases the value.
There are so many variables still. Anything could happen.
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