Finally, there seems to be more hope than hype surrounding a new generation of cancer treatments. True, no one is close to claiming a cure. But at the American Society of Clinical Oncology (ASCO) annual meeting, taking place June 6 to 9 in New Orleans, cancer specialists can expect to hear about positive advances with a number of so-called targeted therapies that take direct aim at tumor cells while causing minimal side effects.
That's in sharp contrast to the last few years' meetings, where there seemed to be more disappointments than victories. "In the past 10 years, there has been an explosion in our understanding of what causes cancer and what makes it spread," says Dr. Lee Rosen, director of developmental therapeutics at St. John's Health Center in Santa Monica, Calif. "All that drug-development work is finally becoming clinically meaningful. That's why you are seeing rapid-fire advances this year."
ASCO can have a huge impact on the fortunes of companies presenting data on clinical trials at the meeting, and stocks often show big fluctuations in reaction to the results. Consequently, the more than 20,000 attendees contain a healthy smattering of drug and biotech analysts boning up with the oncologists on the latest treatments.
AVASTIN'S ACHIEVEMENT. Foreshadowing this year's meeting, the June 3 issue of the New England Journal of Medicine carries the final data on a study that made headlines at last year's ASCO: Avastin, a revolutionary new cancer drug from Genentech (DNA). Avastin is the first drug in decades to significantly extend survival in patients with advanced colon cancer. According to the study, Avastin, when combined with standard chemotherapy, improved the median survival in patients by almost five months, to 20.3 months, and reduced the risk of death by more than 30%, compared with those patients who received chemotherapy alone.
Preliminary news of this study was reported in 2003, and based on that data the Food and Drug Administration (FDA) approved the drug this past February. Avastin is the first drug to win approval that uses an approach called antiangiogenesis, which blocks the tumor's blood supply. The approach was viewed with skepticism by many in the oncology community for years, but at this year's ASCO Avastin will have pride of place as one of the few drugs to actually help cancer patients live.
"To put this in perspective, up until the year 2000, median survival in patients with advanced colorectal cancer was about 12 months," says Dr. Fairooz Kabbinavar of the Jonsson Cancer Center, part of the University of California in Los Angeles. "In just four short years, we're now looking at survivals in excess of two years. We've come a long way."
KILLER TO CHRONIC? Genentech has come along way as well: It will also be presenting survival data on Tarceva, a drug it is developing with OSI Pharmaceuticals (OSIP) and Roche Holdings AG. Tarceva blocks a growth factor used by cancer cells to spread wildly, and in May the companies announced that the drug extended the lives of patients with late-stage nonsmall-cell lung cancer, the deadliest version of the disease.
The Tarceva results mark the first time in decades that survival has been extended in this hard-to-treat group of patients, and analysts expect the drug to be approved quickly by the FDA as a result. The full details of this trial will be presented at ASCO, and oncologists and analysts alike will look closely at the data to determine just how well the drug works and with which patients.
They will also be looking closely at clinical trials that combine Tarceva and Avastin in patients with kidney and lung cancer. The outcome of these trials will have significance beyond the drugs involved. Oncologists have long speculated that targeted therapies will work best when used in combination, either with traditional chemotherapy treatments -- or with each other. The goal is to come up with a cocktail of drugs, tailored to each patient's cancer, that will keep the disease in check, turning it into a chronic disease.
Other combination trials will be presented, with the most closely watched likely to be those involving AstraZenenca's (AZN) Iressa and ImClone Systems' (IMCL) Erbitux. Both drugs take aim at the same target as Tarceva, and both were approved by the FDA since last year's ASCO. Those approvals, however, were based on very low response rates. Iressa works in only 10% of lung-cancer patients, and Erbitux in about 24% of colon-cancer victims. Attendees at this year's meeting will be looking for evidence that those drugs can work on a larger group of patients, other types of cancer, and that they can extend survival.
OTHER USES. Trials testing drugs against rare and hard-to-treat cancers will also claim the attention. Oncologists are particularly interested in the performance of Pfizer's (PFE) experimental SU11248 against kidney cancer as well as several treatments being investigated for brain cancers. Some of them, incidentally, involve traditional chemotherapies such as Eloxatin, by Sanofi-Synthelab (SNY), currently approved for colon cancer, and Eli Lilly's (LLY) Gemzar, which is approved for breast cancer.
Specialists aren't too worried if these trials turn out to be negative, because even when a drug fails to meet its goals in a particular trial, the data may point to a better use of the treatment. The FDA just informed Allos Therapeutics (ALTH), for example, that it would reconsider its brain-cancer treatment RSR13, even though the drug had failed a key clinical trial. In analyzing the data, the company realized that the drug was very effective against brain tumors caused by breast cancer that had metastasized and refiled its application with the FDA for that indication.
"This is a wonderfully optimistic time for oncology," says Dr. Rosen. "Even trials that were negatives can be turned into successes." Patients can only hope that the presentations at ASCO will back up his belief. By Catherine Arnst in New York