Replies to post #135443 on Biotech Values

[iwfal]

CLDX FWIW - If the normal rate of ORR in this patient population is less than 1% or so then they still stand a reasonably good chance of hitting stat sig even with only an expected g+ ORR of, say, 14% or so. Have you done any of the looking at historical rates of ORR in such a highly refractory population?

[mcbio]

. In the entire trial there were 2 (N=33?) ORs.
. 14 were sampled for G+, 9 were positive
. Of those 9, 2 had CRRs (22%)

But what about those not tested? One would expect something like 10 G+ in those, and they had 0 ORs.

And I would assume that both ORs were intentionally included GPNMB sampling, so that the sampled subset is biased from the start.

I take the PR to read that 10 patients out of the entire patient population had triple-negative breast cancer. The PR also notes that GPNMB is frequently expressed in these patients. I imagine those patients with high GPNMB probably came from the triple-negative group. So, I doubt that 22% ORR figure is out of line for all patients having high GPNMB. Whether or not that type of response carries forward into the Phase 2b is a legitimate question. But I do take that number as likely being a reasonable estimate of the patients with high GPNMB that had an ORR in the Phase 1/2 trial.