Biotech Values

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XL184 306 SPA

EXEL CEO gave more color on the 306 SPA during Piper Jaffray Health Care Conference Call on Nov 29, 2011. Transcript is terrible, but you get the idea: FDA thought the proposed delta of 17% for pain response rate between cabo and mito/prednisone as too small.

Mike Morrissey

Yeah. Well, I think an SPA would have been certainly to prefer really to go relative to having a loss in agreement on a trial which we believe is a very important part of the process relating to how we hope to again build this commercially differentiated profile for cabo.

That being said, we had a very good dialogue with the FDA. We’ve gone into great detail on the call we’ve had back in October and I think in all the different documentations. We have -- in that dialogue we had two-step process, if you will. We had a pre-end of Phase 2 meetings before ASCO. We’ve got some of the documentation after ASCO. The first set of feedback that we got in the August timeframe was actually very encouraging. We were -- a number of enhancements were suggested to put a protocol around inclusion criteria, response criteria, narcotic optimization, the nature of the bone scan response and primary what’s their endpoint.

All things that we, I think we’re very happy to deal with and include in the protocol relative to the fact that we had very high level of confidence in the bone scan response data that came from the RDT trial, as well as but we were seeing not from the normal randomized that was recently published now at EORTC.

I think the difference came into play on the second round of feedback, where I think the magnitude of the response was being to be small or too small relative to the potential for inability to under winding by the differential AE profile of cabo versus mitoxantrone.

We had a 17% delta in the confirmed team response rate between cabo and mito/prednisone. Cabo was the trial was designed at 25% confirmed response rate for pain, for cabo 8% was mitoxantrone/prednisone. And the feedback was that well that’s probably through small to be able to get around the idea of underlying with chemo.

And that was a judgment issue, I think at that point in time we had pretty clear picture of what the agency was looking for in terms of the overall protocol, importantly the magnitude of the effect of 25% versus 8% was reasonable. We think we could probably beat that certainly the -- if you look at the NRV data from EORTC that the number of patients that had about a 30% reduction was about half the patients that we studied, so using that as kind of a good metric for what we might see in 306, one could imagine we had a much higher confirm pain response.


We weren’t prepared to commit to a higher level, why raise the bar for a trial that obviously is important one too, I think the issue is the data will define the utility of that lead out relative to a label and we don’t really response for that, the data will speak for itself. We’re planning to run the trial very, very carefully and collected exhaustively and we’re confident in what we’ve seen so far from a data point of view relative to this impact on pain.

Again, this is a different profile and we’re seeing some other compounds to-date. Our goal ultimately is to have a survival trial i.e. 307 and the pain trial 306 lead out at approximately the same time where we’re modeling in the first half of 2014, if that is to be the case maybe a little bit sooner, we would be able to then again have a strong foundation to go forward with a label that would support both the survival we have, but also a reduction in pain, reduction in narcotics both in response.

So ultimately it’s that differentiated commercial opportunity that will drive value and we, again, based upon the data that we have from the last 275 patients its going pretty good as how that’s going to go.

http://seekingalpha.com/article/311125-exelixis-ceo-discusses-at-piper-jaffray-health-care-conference-call-transcript?source=yahoo