In today's call Scott said the planned P2 trial of 427 with abiraterone will be "agnostic" with regard to whether patients are pre- or post-chemo, i.e., the trial may enroll both. Here's a link to the webcast (the comment is about 17 minutes in):
That's a departure from what he said a couple of CCs ago, when the trial was supposed to enroll pre-chemo patients. It's consistent with slide 15 of today's presentation, which is on OGXI's website, but oddly not with slide 4, which says the trial will be in the pre-chemo population. So obviously the design of this trial, which they hope to begin in 2H of this year, is something of a work in progress.
He also said that while the 180-patient 3-arm P2 trial of 427 in metastatic bladder patients is intended to set up a P3, if the results are "very good" they might suffice for filing an NDA. (He mumbled something similar at the end of the RBC call but said it slightly more audibly here.) He quickly uttered a disclaimer to the effect that that's not their current strategy.
Some other things I caught in the RBC and Citi calls: the P1 PD trial involving 011 and paclitaxel does not necessarily have to be completed before they and Teva initiate the P3 trial of 011 in lung cancer. And, enrollment in the SATURN trial is going slowly because patients have to have stable pain and analgesic levels in the week leading up to enrollment and not many do. He said that since the FDA has said that success in the SYNERGY trial alone should suffice for approval that's not a major concern.
Maybe we'll get more clarity on the above in Thursday's Q4 CC.
Thanks. These are indeed very interesting pieces of information. I agree that 427 strategy is still being decided. I have confidence that the decision will be the right one.
I also heard back from IR about some related issues.
Due to TEVA's policies, the co cant answer (or address at the CC) the interim related questions I had (number of events for interim, number of events to unblind, etc.). Thanks TEVA.
With respect to the p value question, since Saturn is delayed, the phase 2 will be a supportive trial for registration (p value =0.06). However, since the size of the P2 trial was relatively small and p>0.05, hitting a p value much less than 0.05 is a good idea.
Due to the increase from 800 to 1000, the hazard ratio has been revised from .725 to .75. IR did not answer my question about the revised power which would have allowed me to reverse the power calculations.
I also listened to the CC yesterday. Scott was firm on completing the enrollment this year but very soft on the date of the readout. I got the feeling that the readout in the SYNERGY trial will be further delayed to 2014, which is normal considering that all the new approvals should extend the median considerably.
Thanks for looking into that and getting back to us. Too bad you couldn't get more info with regard to the interim.
Agree that, especially since the P2 trial for 011 just missed the .05 p-value, it would be helpful if the now-expanded SYNERGY trial can come in significantly below .05. At the very least, the expansion increases that the odds that they'll achieve .05.
Also agree that they'll likely come up with the right strategy on the 427 + abi P2 trial. By including post-chemo as well as pre-chemo patients they should enroll faster, especially since abi is currently approved only for the post-chemo population. Both 427 + abi and 011 + MDV3100 could be very big indications. The question, as Scott touched on in response to a question at the end of the Cowen presentation, is whether Teva will fund an 011 + MDV3100 trial once the latter agent is approved.