The annual American Society of Clinical Oncology meeting is something akin to the Olympics of fighting cancer. Set to begin in Orlando on May 18, the three-day confab -- the largest meeting of its kind in the world -- is where pharmaceutical and biotech companies traditionally announce the results of their latest clinical trials. This year, though, expect to hear a lot less market-moving news about promising breakthroughs and a lot more questions and analytical probing.
More than 150 experimental drugs will be discussed at the meeting, which typically attracts close to 20,000 cancer specialists. Making this year's gathering different are the high-profile failures before the Food & Drug Administration over the past year that have dampened expectations considerably. One of the stars of the 2001 ASCO meeting -- ImClone Systems' Erbitux -- turned out to be a huge disappointment. In December, the FDA summarily rejected the application for Erbitux, saying ImClone failed to provide adequate documentation. The watchwords this year, then, are "lowered expectations."
Unlike 2001, when Novartis' breakthrough cancer drug, Gleevec, was approved just before ASCO, there have been no preconference announcements this year. In fact, the results of two much-anticipated late-stage clinical trials, of Genta's Genasense and AstraZeneca's Iressa, won't be presented at this year's meeting because the data aren't ready. "It's not going to be the most exciting ASCO in recent memory," says Lehman Brothers analyst Joseph P. Dougherty.
SMALL STEPS. Still, Dougherty adds, ASCO is always important for companies in oncology and cancer research. "It is their largest single opportunity to communicate with oncologists," he says. And given that it can take 20 years to develop a drug, having a new powerhouse emerge from ASCO every year is an awful lot to expect.
Watch for news of more incremental progress this year. Most of the attention will focus on new targeted therapies, such as Gleevec, that are just beginning to reach the final stages of human testing. These drugs zero in on specific targets on cancer cells, like growth factors, but do not harm healthy cells. While they're not always as effective as old fashioned chemotherapy, they're far less toxic and so may be able to turn cancer into a manageable, chronic disease rather than a fatal one.
Some of the biggest crowds will likely attend AstraZeneca's presentation on Iressa, a promising drug for the treatment of non-small-cell lung cancer (the deadliest form of that disease). Ironically, Iressa works in much the same way as ImClone's Erbitux -- it aims to both target and block a cellular signal that tumors need to grow and spread. But AstraZeneca has conducted its clinical trials much more cautiously than ImClone did, so it has a better chance of winning FDA approval, which is expected sometime this summer.
EYES ON GENENTECH. Millennium Pharmaceuticals is also likely to create a buzz with its drug MLN341, a targeted treatment for multiple myeloma, a blood cancer. Early results from a midstage trial of the drug were presented last year and looked promising. The final data will be released at ASCO.
The meeting may resolve the speculation on Wall Street -- much of it negative -- about Genentech's drug Avastin, a treatment for breast cancer. Avastin blocks the formation of blood vessels to cancer cells, essentially starving the tumor. However, this class of drugs has had disappointments to date, and analysts are concerned that Avastin may cause serious side effects. The data presented on May 21 will be vetted carefully by attendees seeking to confirm or allay those concerns.
Some drugs will get their major debuts at ASCO, among them ABX-EGF, jointly developed by Immunex and Abgenix, and Telik286, from Telik. ABX-EFG, being tested against renal cell cancer, is similar to ImClone's Erbitux. The companies will be releasing midstage trial data, often used as the basis for FDA applications. And interest is growing in Telik's very novel drug, which breaks down a tumor's resistance to chemotherapy. "We expect ASCO to be a pivotal event for the company," says Lehman's Dougherty.
Any number of sessions will be devoted to new ways of using old-fashioned chemotherapy drugs. For patients now suffering from cancer, those are likely to be the most significant presentations, because chemotherapy is still the primary weapon against cancer. All the attention to and interest in experimental drugs has yet to change that sad reality. By Catherine Arnst in New York