GALAXY-1 interim results
“A randomized study of ganetespib, a heat shock protein 90 inhibitor, in combination with docetaxel versus docetaxel alone for second-line therapy of lung adenocarcinoma (GALAXY-1)”
Abstract #: CRA8007
Date and time: June 3, 5:15 – 5:30 PM
Location: Oral Abstract Session – Lung Cancer. E Hall D2
Presenter: Suresh S. Ramalingam, M.D., Emory University, Atlanta, GA
The interim overall survival analysis of the adenocarcinoma patient population of GALAXY-1 planned for six months from the November 2012 completion of the primary enrollment stage of the trial will be conducted later this month. Results will be reviewed by an independent data review committee prior to presentation.Abstract content
Except for the GALAXY-1 abstract (CRA8007), which is expected to remain under embargo until 6:30 AM CST on the day of the presentation,
Anyone who guarantees a result should be summarily dismissed as a fool or a lying vermin or both, like this aw001. The interim phase I data was good enough to allow the company to meet with the FDA to design and start their phase III Galaxy 2 trial. I would have preferred waiting until at least this interim data was in, but that is water under the bridge. Selling some before June 3 isn't a bad idea, especially if there is a nice run up, or you have bought a decent amount on margin. I may do so myself if there is a run up, and it is high enough.
As far what to expect, a "home run" will be in entire the ITT population in Galaxy 1 reached statistically significant increase in OS. I don't expect this, and SNTA doesn't need this. A very good result will be if the groups which comprise the Galaxy 2 patient base reach statistical signiicance in OS. That is what I am hoping to see, so will be anxiously awaiting the data release. One group omitted from Galaxy 2 is current smokers, and you can see from previous interim data they had a HR over 1, meaning Ganetespib was toxic to this sub-group. I assume this will continue to be the case in this interim release.