March 12 Biotech Update- Ovarian Cancer in the News

The broad sector continues to try and finds its footing, so there is really nothing new on that front. I want to spend this note talking about two companies that I have been receiving questions on the past couple of days. Please keep the questions coming as I want to make sure and touch on companies that people are thinking about. Otherwise I will just write on what is on the top of my mind and might not be on yours, so the more questions the better.

1. So most of the questions are in reference to ECYT. Some have to do with the timing of the NSCLC data and others with what the OXGN data mean for ECYT. I will tackle OXGN first. The most important point to note is that the OXGN study is in a different indication in that it includes both platinum sensitive and resistant patients (we do not know the mix in the trial so it could be relatively close to ECYT or very far). This is critical as it is much easier to find a statistically significant benefit when using a platinum sensitive population (although perhaps that is only true with a chemo based therapy) and the whole crux of ECYT argument to the CHMP is that platinum resistant patients are such a high unmet medical need. So there is not strictly an apples to apples comparison. The second point is that the control group may not be relevant. Avastin has been examined as a single agent in recurrent ovarian cancer but its use is more as a combination with chemotherapy. So the real question for OXGN is how the combination stacks up to a standard of care chemotherapy control arm? Sure the combination may be better than avastin as a monotherapy and still be significantly worse than the standard of care. We do not know the answer to this question because the trial was not comparing the treatment arm with a SOC regime. This is not to bash OXGN as it is cheap and the trial hit but the point is to show that this is not even close to being a competitive threat for ECYT (at this point). As a final point, keep in mind that vintafolide is not just an ovarian cancer drug but one that targets FR positive tumors, which appear in numerous cancer types. Ovarian cancer is simply the first of what is hoped to be many indications.

2. The second question I have received about ECYT is the timing of the NSCLC. In particular, if we do not hear something soon does it increase the likelihood that the data are not good? The short answer is yes but I do not think we are at that point yet. If we are approaching the end of next week and are still waiting, then I would start to worry and think about hedging again. At this point we are still within a reasonable window for the data given the need to clean the data and work through the MRK bureaucracy for release. This does not mean it will be positive if released today; rather, we should not start taking down our odds of positive data until we get later into next week but this is certainly something we need to watch.

3. The other company I received some questions about is ONTX. The issue is their use (or misuse) of the term post hoc. We all know they missed the primary endpoint in their high risk MDS trial but that there was a subset that showed a positive effect in a “post hoc” analysis. We should all be wary of data mining and the company talked about this analysis in a data mining manner but when you read to the recent CC transcript it appears that the subset was predefined and its analysis planned ahead of time. This is not post hoc in the data mining sense, so why does the company not make more of this? I think the company is being too conservative to the point of hurting the PPS. It seems to me that the analysis was prospectively defined and the use of the term post hoc is not necessary. That being said we should not suddenly talk about the trial as being a success but it does provide space for the high risk MDS indication to come back alive. So approval odds are marginally higher but still a distant long shot. This is just another in a series of missteps by management and it seems more to me that this is a management team not used to running a public company, so hopefully they improve (sooner rather than later).

I will call it a day here and hope everyone has a great day.

Disclosure: Long ONTX, MRK, and ECYT.

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  1. Hi David, the bear thesis on Precedent study states that "In fact, the entire vintafolide benefit Endocyte observed in the phase II Precedent study is readily explained by the fact that vintafolide-treated patients in this unblinded study received significantly more PLD than the control patients (162.5mg vs. 100mg.) " Where did they get this data about PLD dosing and whats your opinion about it? Thanks Miguel
    Mar 12, 2014 |
    • Dave Sobek
      It may have come from the JCO article but I've not been able to access that article or track down that data point. Could that have caused the results? Sure but do we know of a dose response for PLD in platinum resistant ovarian cancer of this size? I have not seen a study that showed that. Clearly ECYT is a high risk/high reward play, so at this point we need to see how it shakes out. Plus, this has little to do with the NSCLC trial data. If vintafolide had no effect the DSMB would have forced people off of the monotherapy arm.
      Mar 12, 2014 |
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