Gunning for Best-in-Class Status

Being best in class is great, but it puts a target on your back that everyone is trying to beat.

Dendreon's (Nasdaq: DNDN  ) Provenge showed a solid 4.1-month increase in overall survival in metastatic prostate cancer patients, beating the paltry 2.4-month increase from Sanofi's (NYSE: SNY  ) Taxotere. Other drugmakers aren't content picking up Provenge and Taxotere's leftovers, though; they're looking to move into the first-line metastatic prostate cancer market as well.

First up today is Johnson & Johnson (NYSE: JNJ  ) , which said it stopped a trial testing Zytiga plus prednisone versus prednisone alone because it was clear that Zytiga was increasing survival. Medivation (Nasdaq: MDVN  ) is also testing its prostate cancer drug, MDV3100, in this population, having shown that it works in the more-progressed population already.

While we know that Zytiga plus prednisone works better than prednisone alone, it's the magnitude of the increase that counts. Johnson & Johnson is saving the number for a medical meeting, but we can take some stabs at whether it might beat Provenge based on what we do know.

A larger difference in survival is required to stop a trial early than is required to show an effect if the trial goes to completion, so the early end suggests a large difference for Zytiga. But Provenge's pivotal study, which squeaked by with a p-value of 0.032, enrolled only about 500 patients while the Zytiga trial had more than 1,000 patients in it. With more patients, you can detect a smaller difference with the same p-value; if you're flipping coins, the difference between 445 heads and 455 tails isn't as significant as the difference between 45 and 55 even though they both have a delta of 10.

Of course, not all the 1,000 patients read out, since the trial was stopped early; if you assume the interim peak was halfway through, the minimum increase that Zytiga could show is probably higher than the 4.1-month increase Provenge demonstrated. If the interim readout was later, Zytiga could, theoretically, show a smaller difference that was statistically significant enough to justify stopping the trial earlier.

Even if Zytiga does show a larger increase in overall survival, which I'd guess is the case, and you ignore all the usual precautions about comparing results with different control groups, the results might not be that bad for Dendreon. The two treatments work in entirely different manners, so doctors could use them sequentially or concurrently, which Dendreon is currently testing. If you can't beat 'em, join 'em: Seems like a reasonable strategy when companies are gunning for you.

These three American companies are gunning for the rest of the world. Find out who they are and why Fool analyst Jim Royal likes them so much in this free report.

Fool contributor Brian Orelli holds no position in any company mentioned. Check out his holdings and a short bio. The Motley Fool owns shares of Dendreon and Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of and creating a diagonal call position in Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.


Read/Post Comments (2) | Recommend This Article (5)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On March 08, 2012, at 8:43 PM, DAG1996MF wrote:

    Thank you for this rare objective evaluation... it gets quite tiring sifting through the many write-ups now sprouting up to proclaim Zytiga the "winner". It is very discouraging that so many seem to forget that we're talking about the lives of individuals so its great if every one of the "competing" treatments turns out to be hugely successful.

  • Report this Comment On March 09, 2012, at 4:44 AM, jarat wrote:

    A spokesperson for J&J reported that Overall Survival (OS) for this Ph 3 study was not statistically significant, though Progression Free Survival (PFS) was. Seeing that OS is the gold standard of cancer drugs, I'm baffled as to why this announcement had the effect on share prices that it did. A non-statististically significant result is, in scientists' thinking, NO result, even if there was a strong trend. For example, Provenge (DNDN's prostate cancer drug) had a "strong trend" for PFS with its three Phase 3 trials, but they were not statistically significant. The common understanding (in the media anyway) is that Provenge has "no" impact on PFS. Since Zytiga's first approval was based on a trial that was also stopped early (albeit with a stat signif OS number), I would think that this latest news was anything but positive for Zytiga's case for use in Provenge's space.

Add your comment.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 1805512, ~/Articles/ArticleHandler.aspx, 10/22/2014 5:46:39 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement