One of the major biotech events of the year is fast approaching. The annual meeting of the American Society of Clinical Oncology (ASCO) will take place in Chicago from June 4 to June 8. This event is like Woodstock for biotechnology - if Woodstock were clean, air-conditioned, and had plenty of restrooms. If you invest in biotechs or pharmaceuticals that want to play in the huge and well-reimbursed world of oncology, this is one of the major events of the year.
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Ahead of the meeting, ASCO releases a list of abstracts that scientists and companies will present. In some cases, these abstracts give away at least most of the story (efficacy, safety, etc.), while other abstracts are embargoed until the meeting itself. In any case, investors can still look forward to follow-up data (abstracts are submitted well ahead of the meeting) and often the amount of attention garnered by a presentation reflects overall interest in the compound.
Here we present some of the companies presenting abstracts at ASCO.
The data that Celgene will be reporting at ASCO could significantly impact the company's revenue expectations. The company has been studying the use of its already-successful drug Revlimid as a maintenance therapy for other cancers, including multiple myeloma. The advantage to Celgene from Revlimid as a maintenance therapy is that it the drug would be used for long stretches of time to keep cancer in check. Callous as it sounds, that is worth a lot of money to a company as opposed to a one-and-done therapy. In any case, the abstract indicates that Revlimid may double a patient's three-year chances of progression-free survival.
Delcath Systems (Nasdaq:DCTH)
Delcath has announced that ASCO accepted an oral presentation of Phase 3 data of the company's percutaneous hepatic perfusion therapy for liver metastases from melanoma. In this case, though, we know the data will be good. The company announced earlier in May that Phase 3 data indicated that this therapy more than tripled survival-free progression, with a better side-effect profile. One of the great things about this therapy is that it delivers the chemotherapy agent directly to the organ and reduces overall toxicity - allowing for much higher dosages. All told, there could be some pretty sizable off-label potential here, though I expect the company will do follow-on studies as time goes on. (For more, see Stocks On Drugs: What It Takes To Get High.)
With oncology being such an important part of Roche's business, it is no real surprise that this Swiss giant will have some abstracts to present. The company is scheduled to report Phase 3 data on Avastin in ovarian cancer. Interestingly, the company said the results are under ASCO embargo, yet the company pointed out that they were "positive results", that the study met the primary endpoints, and improved progression-free survival. So much for the embargo, eh?
Roche will also present data that should be supportive of Avastin in colorectcal cancer, including the potential for using it as maintenance therapy. Last and not least, the company will be presenting Phase 1b/2 data of trastuzumab-DM1 in breast cancer. (For more, see Measuring The Medicine Makers.)
Ziopharm Oncology (Nasdaq:ZIOP)
Ziopharm has already announced that the study it will be presenting at ASCO was stopped early due to its positive efficacy and the abstract has been selected for a "Best of ASCO" session. Ziopharm is researching the use of its drug palifosfamide for the treatment of sarcoma, and the company indicated that there were 28 progression-free survival results out of 62 patients. Ten of these results were due to the palifosfamide arm of the study, and the overall median progression-free survival was 7.8 months in the palifosfamide combination arm versus 4.4 months in patients receiving doxorubicin alone.
ZymoGenetics is another biotech that has released a lot of its exciting ASCO data ahead of the actual meeting. The company is studying the use of its interleukin 21 (IL-21) cytokine in various cancers, but the ASCO data will focus on metastatic melanoma. A Phase 2 study in stage four metastatic melanoma patients showed a 24% response rate and mean progression-free survival time of 5.2 months. Though that may not sound impressive, these are very sick patients and the average response from prior studies of this disease with other drugs was about 1.6 months.
The Bottom Line
ASCO is a major meeting, but it is never the end-all be-all for any biotech or pharmaceutical company. Even a successful Phase 3 result can still ultimately lead to FDA rejection, as investors unfortunately learned with XenoPort's (Nasdaq:XNPT) surprising rejection earlier this year. For companies presenting data on Phase 2 or Phase 1 studies, the odds are even longer as success in Phase 2 predicts success in later studies less than half of the time. By all means, be encouraged if a company whose stock you own presents solid data. But do not lose sight of the bigger picture - biotechnology is always a crap-shoot, and investors would do well to focus on companies with innovative science, strong data, ample cash, and a pipeline that goes deeper than one or two Phase 1 studies. (For more, see The Ups and Downs Of Biotechnology.)
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