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Biotech Stock Mailbag: ASCO, Celldex, Obesity Drug Game-Changer


BOSTON ( TheStreet) -- This week's Biotech Stock Mailbag focuses on two big topics, the upcoming ASCO cancer meeting and Celldex Therapeutics (CLDX) (with some Galena Biopharma (GALE) thrown in for kicks).

I also take a rare detour from biotech stocks to write about Zafgen, a privately held obesity drug company. Let's start with ASCO.

Phil K. asks, "What are your expectations for the ASCO meeting now that the abstracts have been released? What will you be focusing on when you get there?"

By this time next week, I'll be on a plane to Chicago to cover the American Society of Clinical Oncology's (ASCO) annual meeting. This is my 12th ASCO meeting. ASCO is the biggest, loudest cancer drug meeting of the year, although some are more investor-worthy than others. Based on recent chats with professional health-care investors, ASCO 2012 is a relatively low-priority affair because the number of stock-moving data presentations is limited.

ASCO meetings, just like life, have their ups and downs, and this year is definitely a more subdued ASCO.

Nothing wrong with that, and investors and scribes like me will still find plenty of interesting data presentations. I'm looking forward to ASCO this year because I may actually have the time to slow down and learn something new instead of sprinting from session to session trying to cover all the news as quickly as possible.

With that introduction, here is my take on the three ASCO data presentations most likely to make waves with investors when trading opens on Monday, June 4.

1. Johnson & Johnso (JNJ), Medivation (MDVN) and Dendreon (DNDN), also known as the prostate cancer triumvirate.

J&J will present data from the "302" study of Zytiga in pre-chemo prostate cancer patients. This phase III study was stopped early due to a statistically significant progression-free survival (PFS) benefit favoring Zytiga over the control arm. We also know that overall survival (the more important co-primary endpoint) favors Zytiga but is not statistically significant.

The key question for the ASCO presentation: What's the actual survival benefit in the Zytiga "302" study? The line of demarcation is four months -- that's the survival benefit of Dendreon's Provenge in basically the same prostate cancer patient population. If Zytiga's survival benefit is greater than 4 months (let's call it 5-7 months) J&J and Medivation win and Dendreon loses.

If the survival benefit of Zytiga comes in lower than Provenge, Dendreon wins and J&J and Medivation lose.

What does Medivation have to do with all this? Remember, Medivation is developing MDV3100, a drug similar to Zytiga but with efficacy that (so far) looks better. So, what's good for Zytiga should be even better for MDV3100.

One more important point of focus for the Zytiga "302" data: Why isn't the survival benefit statistically significant and what does that mean for the overall analysis and interpretation of the data? It will be interesting to hear from the presenters on this point and to see how oncologists react once all the data is aired publicly.

2. Ariad Pharmaceuticals (ARIA): The six-month update of the pivotal study of ponatinib in chronic myeloid leukemia patients. Expectations are for higher response rates to be shown at ASCO compared to what was presented last December at the three-month look.

3. Array BioPharma (ARRY): Investors want to get a much closer look at the phase II data on selumetinib in hard-to-treat patients with KRAS-mutant non-small cell lung cancer. The research abstract showed a median overall survival in the selumetinib/docetaxel arm of 9.4 months compared to 5.2 months for docetaxel alone -- a difference of 4.2 months but not statistically significant. Response rate (37% vs. 0%) and progression-free survival (5.3 months vs. 2.1 months) both favored selumetinib/docetaxel over docetaxel alone with statistical significance.

Honorable mentions: Onyx Pharmaceuticals (ONXX) and the deeper look at response rates in its pivotal trial of the multiple myeloma drug carfilzomib; Pharmacyclics' (PCYC) BTK inhibitor ibrutinib; the PD-1 immunotherapy from Bristol-Myers Squibb (BMY); the BRAF inhibitor dabrafenib from GlaxoSmithKline (GSK); and data on the breast cancer drug T-DM1 from Roche (RHHBY) and ImmunoGen (IMGN).

Shares of Celldex Therapeutics closed up 5.2% Thursday, a day after the company released interim results from a phase II study of its breast cancer drug CDX-011. Given the high investor expectations for these data and the real potential for a sell-on-the-news reaction, Celldex's rising stock has to be seen as a victory and an optimistic signal from Wall Street for the future potential of CDX-011.

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