Quick note from Musa Mayer who is attending the Conference:
While the full presentation won't occur until tomorrow afternoon, today they released some of the findings, and I just had to tell you what I know, so far:
"Analyzes of the first 86 patients of a planned 120 patients showed that BSI-201 + G/C (Gemzar and Carboplatin) had improved CBR (clinical benefit rate, those with tumor shrinkage or stable disease), median PFS (progression-free survival) and median OS (overall survival), compared with G/C alone. The frequency and nature of adverse events (AEs) did not differ between arms."
How much of an improvement is what's impressive.
* CBR is 12% with G/C vs. 52% with G/C+BSI-201.
* Median PFS is 87 days with G/C and 211 days with G/C+BSI-201 with a HR (hazard ratio) of 0.30. In case these numbers don't mean anything to you, this amounts a 70% improvement in progression-free survival.
* Median OS: patients in the G/C arm had a median survival of 169 days, but patients on the G/C arm of the study had a median survival of more than 254 days, for a HR of 0.24. That means that patients exposed to the experimental drug lived 76% longer.
If these findings hold up in the completed study and in a full-scale Phase III trial of sufficient size to be definitive--and that's a big if, of course--this magnitude of benefit will be beyond any breast cancer drug we've seen in the 15+ years I've been following drug development. However, this is a small number of patients, not even the full number enrolled in the study, and the study itself isn't sufficiently powered to show a definitive difference.
The results of the entire study, with all 120 patients along with some studies of PARP expression will be presented tomorrow afternoon--you'll be hearing about it on the news. I'm excited!
Great news, Musa! Thanks for sharing.