) --The ides of March are upon us, when thoughts turn to spring training, daffodils, March Madness . . . and cancer drug stocks.
The American Society of Clinical Oncology annual meeting kicks off in the first week in June. Seems far off but it's not, especially since savvy investors know that making money on the "ASCO trade" means getting in early as cancer drug stocks typically trade up into the closely watched medical meeting.
To help with your ASCO prep, capsule summaries of seven stocks expected to present significant cancer drug research at this year's ASCO meeting are presented on the following pages. Lots more will be said about these and other cancer drug stocks as we get closer to the meeting. Circle May 16 on your calendar -- that's when ASCO will be posting research abstracts for the meeting on its Web site.
In no particular order, here are
every biotech investor should have on their radar screens, beginning with
ASCO presentation: Phase IIb study of CDX-011 in refractory breast cancer.
What we already know: Not much. ASCO (or the release of ASCO abstracts) will be the first dissemination of results from this study. Celldex enrolled 120 patients with advanced breast cancer that over-expresses a protein known as GPNMB (confirmed by an independent test). The patients, all of whom no longer respond to currently approved treatments, are then randomized to receive either CDX-011 or physician's choice of treatment. The primary endpoint of the study is overall response rate.
Other notes: CDX-011 is a monoclonal antibody drug conjugate. The antibody portion targets cancer cells that express the GPNMB protein, which has been shown to correlate with poorer outcomes in breast cancer patients. When the CDX-011 antibody attaches to GPNMB-expressing tumor cells, it releases a toxic chemotherapy payload. This "drug conjugate" was licensed from
and is the same one used in the newly approved lymphoma drug Adcetris.
Celldex CEO Anthony Marucci has said previously that a meaningful and positive response rate in the study would be 12% to 15% with a progression-free survival of greater than 12 weeks.
ASCO presentation: A phase II study of tivantinib (ARQ-197) in second-line liver cancer.
What we know already: Top-line data from this phase II study were released in January. Liver cancer patients who progressed after first-line therapy were randomized 2:1 to receive tivantinib or a placebo. The study met its primary endpoint with tivantinib demonstrating a 56% improvement in time to tumor regrowth compared to the placebo.
Key questions: Tivantinib dose was reduced mid-study due to reports of low blood cell counts in some patients. The ASCO presentation will provide details on how each tivantinib dose performed. Key secondary endpoints in the study, most notably overall survival, will also be presented.
Placebo patients were allowed to cross over and receive tivantinib when their tumors started to grow again.
Other notes: Arqule and partner
are conducting a phase III study of tivantinib, a c-met inhibitor, in non-small cell lung cancer, with an interim analysis expected in the fourth quarter. A phase II study of tivantinib in colon cancer is also ongoing with results possible by year-end or in early 2013.
Johnson & Johnson
ASCO presentation: Phase III study of Zytiga in "pre-chemo" prostate cancer patients.
What we already know:
in prostate cancer patients who have not been treated with chemotherapy. Zytiga also helped these patients live longer, although the survival benefit was not statistically significant. Based on these positive results, independent data monitors stopped the study early.
Key questions: What was the magnitude of benefit provided by Zytiga? In particular, what does the survival benefit trend look like and might it become statistically significant on longer follow up?
Other notes: At this point, the Zytiga study is the biggest attention grabber at ASCO from a Wall Street perspective because the results have far-reaching impact not only on J&J but prostate cancer drug competitors
ASCO presentation: Six-month, follow-up data from the pivotal phase III study of ponatinib in chronic myelogenous leukemia.
What we already know: Results from the first three months of the
were presented last December.
Key questions: Investors will be looking for six-month response rates to be higher than what was seen last December.
ASCO presentation: Full presentation of results from the phase III study of tivozanib in kidney cancer.
What we already know:
were announced in early January with tivozanib demonstrating a progression-free survival of 11.9 months compared to 9.1 months for Nexavar. In a subset of treatment-naive patients, tivozanib PFS was 12.7 months.
Key questions: Nexavar performed better than expected in the study, which narrowed the benefit shown by tivozanib and caused some investors to question the tivozanib's true efficacy. Aveo asserts tivozanib's safety data (to be fully disclosed at ASCO) demonstrates superiority over Nexavar.
ASCO presentation: Selumetinib in second-line non-small cell lung cancer.
What we already know: Last September, Array partner
announced top-line results from the phase II study, in which the combination of selumetinib plus docetaxel demonstrated a "numerically greater increase" in survival compared to docetaxel alone.
Key questions: The survival trend favoring selumetinib wasn't statistically significant but full details on the drug's efficacy, including PFS and response rate endpoints, will be presented at ASCO.
ASCO presentation: Phase II studies of PX-866 in solid tumors.
What we know already: Phase I trials showed PX-866 to be well tolerated with some evidence of anti-cancer activity. Oncothyreon is conducting phase II studies of PX-866 in combination with other drugs in non-small cell lung cancer, glioblastoma, prostate cancer, colon cancer and head-and-neck cancer.
Key questions: These studies are expected to complete patient enrollment by the end of the year. Oncothyreon is expected to present interim results from one or more of these trials at ASCO.
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--Written by Adam Feuerstein in Boston.
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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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