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Sunday, March 06, 2016 6:45:40 AM
If the decision was in fact made to drop the post phase 1 expansion, I wonder why? Why not simply have both?
One reason would be if the company strongly feels that the only way forward is as a combo drug- they have chosen docetaxel for ovarian, and perhaps irinotecan for pancreatic CA.
Unsure what other advantage there might be - you could argue that having even one patient enroll in a non standard comparison trial is losing that patient to prove statistical significance a better trial, a P2 instead of a p1 add on.
The problem with that is the time lapse. They could have already been treating pts at DF/BI with new protocol and instead we are just waiting. They could have valuable data back on tolerance/effect of 3x weekly dosing too. Presumably they do not see the time lag as important. The time lag may very well be very important though- no current funds for a phase 2 with Mayo for pancreatic to go ahead, so we sit on our hands for...how long? Nothing announced about BI and renal cell CA, or AML. These might move forward with news from a phase 1 expansion that hinted at efficacy but now we are waiting for a long time for phase 2 trials to start and then to yield results(or are we waiting on those 2 cancers/trials for other reasons)
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