The pistons of the biggest publicity engine in cancer R&D will start firing this week. It’s time to behold the annual rite of the American Society of Clinical Oncology (ASCO) meeting, the biggest event for showing off what’s new and interesting in the treatment of cancer.
This conference, officially held June 1-5 at McCormick Place in Chicago, draws more than 25,000 physicians, pharmaceutical companies, investors, and journalists every year. Organizers have spent years carefully orchestrating this show to make sure it’s the place for all kinds of market-moving, medical practice-changing, and front-page leading news about cancer. Partly to help drum up suspense, things really get started this week, as thousands of (often outdated and incomplete) abstracts of clinical trial results are posted on the ASCO website, as a preview of coming attractions in Chicago. The abstracts are due out at 6 pm ET on Wednesday.
Despite the excessive hype in this business, where a few extra months of survival counts as a breakthrough, there are really encouraging things happening in cancer treatment. There’s undoubtedly tons of money to be made, which explains a lot about the spectacle that is ASCO. Health insurers now spend an estimated $80 billion a year on cancer care worldwide, and spending in the U.S. is expected to climb an eye-popping 42 percent by the end of 2013, according to a report last year by Medco Health Solutions. There are now about 900 cancer drugs in development.
Most of those drugs will suffer quiet deaths, and never get close to the marketplace, because they aren’t safe enough or don’t work well enough. But here’s a rundown on eight drugs from biotech companies around the U.S. that are sure to make news at this year’s ASCO because they are either on the cusp of reaching the market, or just beginning to scratch the surface of their potential:
—Genentech’s trastuzumab-DM1 (T-DM1) for breast cancer. Evidence has been mounting for years that this “souped-up” antibody drug could be much more potent than Genentech’s original trastuzumab (Herceptin), the pioneering breast cancer medicine that’s almost 15 years old. Now the South San Francisco-based company, a unit of Roche, is getting ready to present data from a pivotal study of 991 women with breast cancer. These women had previously gotten Herceptin, and were randomly assigned to get either T-DM1 or a combo of GlaxoSmithKline’s lapatinib (Tykerb) and capecitabine (Xeloda) chemotherapy.
Genentech said in March that T-DM1 met its main goal of slowing the spread of tumors, and that it was good enough for the company to seek FDA approval of the drug later this year. This study, known as Emilia, also measured survival times. Data on the tumor progression times, and an interim look at overall survival time, will be made public the first full day of ASCO presentations on Saturday, June 2, according to Genentech spokeswoman Emmy Wang. Besides Genentech, this disclosure also means quite a bit to Waltham, MA-based ImmunoGen (NASDAQ: IMGN), which developed antibody-drug linking technology that it licensed to Genentech, in exchange for a “mid-single digit” percentage royalty on worldwide sales of T-DM1.
Partly because this drug is working against a high-profile disease like breast cancer, and partly because of its groundbreaking science as a sort of anti-cancer smart bomb, I’d bet that this drug will be the star of the show at this year’s ASCO. The presentation also happens to be timed for the deadlines of the nation’s major Sunday newspapers. Watch for the headlines on June 3.
—Aveo Pharmaceuticals’ tivozanib for renal cell carcinoma (kidney cancer). The Cambridge, MA-based biotech company (NASDAQ: AVEO) has its biggest-ever presentation coming up this year at ASCO. The company released basic results in January, from a study of 517 patients with renal cell carcinoma, which showed its tivozanib compound was able to keep tumors from spreading for a median of 11.9 months, compared with 9.1 months for sorafenib (Nexavar), an FDA-approved drug sold by Bayer and Onyx Pharmaceuticals. The study was designed to show the Aveo drug could keep tumors from spreading for about an extra three months, so it barely passed. Aveo’s stock fell after the results, but the company has said it is hiring aggressively and getting ready to seek FDA approval. Physicians, investors, and competitors will get their first detailed glimpse at ASCO into what has made Aveo so bullish about tivozanib’s prospects. New details “could provide additional evidence to support a differentiated product profile based on safety,” said Jason Kantor, an analyst with RBC Capital Markets, in a note to clients May 3.
—Onyx Pharmaceuticals/Bayer’s regorafenib for colorectal cancer and GIST. South San Francisco-based Onyx (NASDAQ: ONXX) has been on a roll of late, and it will give physicians and investors a lot of information to chew over at ASCO. Onyx is planning to present data from a pivotal study of regorafenib, a follow-on cancer compound that builds on its success with sorafenib (Nexavar). The company said in January that this new compound offered a slim advantage of about six weeks extra survival time for some very sick patients with colorectal cancer. More data on that trial is expected at ASCO, and so is some new information about regorafenib as a treatment for gastrointestinal stromal tumors (GIST).
The company also will have more to say about … Next Page »
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