Teva, OncoGenex update development program for custirsen Teva Pharmaceutical (TEVA) and OncoGenex Pharmaceuticals (OGXI) announced an update on their development program for custirsen, a product candidate being evaluated in Phase 3 studies for castrate-resistant prostate cancer. In a revised agreement between the two companies, the clinical trial program will now include the initiation of a Phase 3 study to evaluate if custirsen has the potential to improve survival rates for prostate cancer patients when combined with the recently-approved, second-line chemotherapy drug Jevtana. The new trial, which aims to enroll approximately 630 men and is expected to begin later this year, will be conducted in lieu of the Prostate Cancer Saturn Study, a t rial designed with a primary endpoint of measuring a durable pain palliation benefit for custirsen in second-line treatment of CRPC. :theflyonthewall.com
I think there's been more news this quarter than over the previous two years.
It's nice to see Teva showing its commitment to 011 by agreeing to the new trial. Since OGXI's obligations under the partnership deal remain capped at $30mm, Teva is picking up the full cost of this trial, which they said in the CC will cost more than the now-suspended SATURN trial. And they also expect to begin the P3 lung trial in 2H of this year.
One question I have is what would happen with regard to the new prostate trial if -- not that such a thing could ever happen -- SYNERGY were to fail. In the CC they said that one of the main reasons they expanded enrollment in SYNERGY from 800 to 1,000 is that the FDA normally wants safety data on at least 600 patients who've received the new drug. (This is a more reassuring reason than that the FDA may now be requiring a p-value for SYNERGY that's better than p<.05, although that point wasn't discussed so I suppose we can't completely rule that out.) It would seem therefore that success in the 630-patient new trial alone wouldn't suffice for approval. I suppose, though, that even if SYNERGY were to fail on efficacy its safety data could still count. Or they could expand enrollment in the new trial when SYNERGY failed. Or they could present data from both the new trial and the lung trial.
Or, and this probably falls into the category of wishful thinking, Teva has already committed to do a trial of 011 + MDV3100 once MDV3100 is approved. Then you'd be back to two P3 prostate trials.
Even wishfuller thinking: Teva has reason to believe SYNERGY will succeed. It's an open label trial and obviously they're keeping track on enrollment. But in theory, although it's open label to the investigators, Teva and OGXI are blinded. And the trial probably isn't far enough along yet for anyone to assess whether 011 is increasing survival.
Wow! We knew that they were having trouble enrolling. I excepted some change. However I didnt expect a change this dramatic.
I wonder how many patients were enrolled so far (I guess not many. Otherwise, they wouldnt want to throw away 18m of data).
I also wonder when they would unblind the Saturn trial to give us a glimpse of the efficacy of OGX-011 in post chemo setting.
Or is this TEVA being shrewd? First they commit to three trials. Then they delay one. Then cancel the other. Am I just paranoid?
And what's this talk about Cabazitaxel replacing docetaxel? It seemed like they needed to justify this new trial; came up with that answer without thinking what it implies (docetaxel might go away = less value in SYNERGY trial) or without even checking the details of http://clinicaltrials.gov/ct2/show/NCT01308567
I am curious about what the market will take this tomorrow.