Biotech Values

[iwfal]

CLDX -

10 out of 33 triple negative is significantly higher than the general breast cancer population at around 15% already. Thus, it is quite possible they just retested and confirmed the samples they already knew as triple negative BC.

I believe that the 15% you quote is in treatment naive patients. In contrast the enrollment criteria for the ph i was heavily pre-treated patients (i.e. those who had aggressive disease) and thus I'd expect the patients to be enriched for markers that predict aggressive disease (e.g. triple negative and G+) even when the patients are not tested except post-hoc.

But moving more to Ex's point - that doesn't mean that G+ and triple negativity perfectly align and it is reasonable to suppose that the real ORR in G+ patients in the ph i was something less than 22% since the total G+ patient pop in the ph i was greater than 9. In fact if you assume the same proportion in the 20 not tested for G+ as was found in the 14 that were tested then there were another 12+ patients with G+ that had no responses. I.e. 21 G+ patients in the trial and 2 had a confirmed PR (ORR=9.5%).

Question - the poster explicitly notes that only 14 patients were tested for G+ status. But no such limitation was stated for triple negativity. I suspect that they tested ALL patients for triple negativity because it is a common test (whereas the G+ test is clearly not a commonly available test)? Thus the 10 patients found to be triple negative is the complete set and the 1 response is representative of the expected total response rate in this population.