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BioPharm Executive: Your American Society of Clinical Oncology Crib Sheet


5/28/2012 10:28:47 PM

Your ASCO Crib Sheet

On your way to Chicago for the annual meeting of the American Society of Clinical Oncology (ASCO)? For thousands of oncologists, not to mention businesspeople, investors, and others interested in the latest in cancer research, it's the event of the season. If you're more of a homebody, that's okay too, thanks to a legion of reporters, twitter feeds, live bloggers, and so on--you don't actually have to be in the Windy City to catch the breeze. (However, if you want the world's best hot dog, you'll still have to show up in person).

The meeting always covers a lot of ground, and this year is no exception. But there is nonetheless pretty widespread agreement on the presentations that will be moving research...and stocks...forward next week. Don't just take my word for it.... A preview from Xconomy's Luke Timmerman and another from TheStreet.com's Adam Feurenstein, not to mention a Top 10 List from FireceBiotech, a 'What's Hot' summary from the consultants at Kantar Health, and several others all pretty much concur on the highlights. Here's a quick summary of summaries:

• Antibody-drug conjugates (ADCs), where a toxic payload is linked to a targeting antibody, are animating a lot of research and partnering in the pharma sector. Data from a pivotal study on Roche/Genentech's trastuzumab-DM1 (T-DM1) is a watershed moment not just for ImmunoGen, which provided the linking technology, but for the young and exciting ADC field. And it could mean some great news for breast cancer patients. A recently approved ADC, Seattle Genetics' Adcentris, is also in the spotlight. While it is currently labeled for a rare lymphoma, new data will tell us more about its effectiveness in the much more common non-Hodgkin's lymphoma as well as some other CD30-marked tumors.

• The Onyx Pharmaceuticals/Bayer cancer drug Nexavar was a hot topic at least year's ASCO as observers got a look at how well the drug did in treating metastatic breast cancer. This multiple kinase inhibitor, first approved in 2005 and used to treat kidney and liver cancer, is again behind a couple widely anticipated presentations. Aveo Pharmaceuticals is gunning for Nexavar with its drug tivozanib. Earlier this year it showed a modest survival advantage over Nexavar, as well as fewer side effects, in top-line results from a kidney cancer study. But that wasn't enough to convince investors the drug is a winner, and they'll be looking closely for newer data and further details. Onyx and Bayer, meanwhile, are pushing forward with regorafenib, a next-generation successor to Nexavar (and the subject of some now-settled litigation between Onyx and Bayer). The companies just filed for approval of regorafenib in colorectal cancer, and attendees will be closely watching to see what kind of ammunition they have behind this indication. There will also be some data on regorafenib in gastrointestical stromal tumors. And Onyx is also expected to present some new data on Kyprolis (carfilzomib), its multiple melanoma drug that will be going before an FDA advisory committee on June 20.

• Prostate cancer watchers will have new data to consider from Johnson & Johnson, Medivation, and Exelixis. In March, J&J halted a trial of Zytiga early because it dramatically slowed the spread of tumors; investors and clinicians are wondering if Zytiga can be used in early (pre-chemo) treatment and if the positive top-line results reported earlier will translate to gains in survival. That's a challenge to Exelixis, which has pinned all its hopes on cabozantinib. Cabo has shown promise in a wide range of tumor types, but the company is going most aggressively after prostate cancer. It will have nine presentations on cabo at the meeting. Medivation’s enzalutamide was the buzz of an earlier ASCO meeting this year when it reported a marked survival benefit in post-chemo prostate cancer patients, and attendees are hungry for further follow-up. The company just filed an NDA for enzalutamide. Even Amgen will get in the game with a bone metastasis-free survival study on Xgeva (denosumab), although FDA just rejected their marketing application.

• Leukemia gets a focus through a couple highly anticipated presentations. Ariad Pharmaceuticals will be updating attendees on ponatinib for chronic myeloid leukemia, with six-month follow up data. And Pharmacyclics, with partner J&J, will be following up on earlier reports about ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia. New data may be even more promising than the results reported in December, and the companies have exciting data on a combination of ibrutinib and GlaxoSmithKline's Azerra.

Needless to say, that's not all! We'll be looking back next month at the highlights from the confab. Until then, stay healthy.

-Karl Thiel

Read the BioPharm Executive online newsletter May 30, 2012.

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