Investor's Business Daily
Big Cancer Meeting To Showcase Survival
Thursday June 3, 6:39 pm ET
Gloria Lau
The buzz in cancer is about targeted drugs that attack deadly cancer cells but spare healthy cells. This means direct treatment and fewer side effects.
But less than 10 of these drugs have won regulatory approval. Many are only for cancer patients for whom nothing else works.
A few are highly effective, but only in a small percentage of patients.
Others are good at shrinking tumors, but there's no proof that this improves survival rates.
The 40th annual American Society of Clinical Oncology (ASCO) meeting Saturday through Tuesday in New Orleans may answer some of these questions. Researchers funded by 136 cancer drug companies will release details and data. Experts say there are several notables.
The most anticipated is Tarceva, a drug developed by OSI Pharmaceuticals (NasdaqNM:OSIP - News) and licensed to Genentech (NYSE:DNA - News) and Swiss partner Roche.
Tarceva Is A 'Survivor'
On April 25, the companies offered a preview and said that in phase three studies, Tarceva extended survival in patients with late-stage nonsmall-cell lung cancer — a deadly and hard-to-treat cancer. The companies will quantify these results and release details at ASCO.
Tarceva is an endothelial growth factor receptor (EGFR). The Food and Drug Administration approved two other EGFRs this year — ImClone Systems (NasdaqNM:IMCL - News) and Bristol-Myers Squibb's (NYSE:BMY - News) Erbitux and AstraZeneca's (NYSE:AZN - News) Iressa.
But Erbitux and Iressa are proved to only shrink tumors, not extend life. ImClone and AstraZeneca are running further tests in hopes of proving the latter.
For now, experts see Tarceva as the drug class' best hope.
"The drug class has been working, but not in a major game-changing way," said Ian Clark, Genentech's senior vice president and general manager of BioOncology. "Tarceva will offer the major survival data for the class.
"There's absolutely no doubt that survival is the gold standard. In any cancer setting, if a drug has statistically significant survival data, it's more likely to be used by more clinicians for more patients and (bring in) more revenue."
There are other financial reasons that cancer drug makers hope for survival data.
"Insurance companies will find it very hard to (refuse) to reimburse patients for a drug that shows a survival benefit," said Dr. Michael Friedman, CEO of the City of Hope Comprehensive Cancer Center in Los Angeles and a former FDA commissioner.
This is significant because a doctor may want to prescribe a new-targeted therapy, but without insurance support most patients can't afford it. The drugs cost $20,000 to $30,000 per patient per year.
Cancer is the country's second biggest killer, behind heart disease. It afflicts 1.2 million new patients every year, three-quarters of whom are over 55. So investor excitement around cancer drugs such as Tarceva is strong.
OSI shares are trading near 77, up from 38 just before the April announcement. Genentech's shares have climbed more than 3% to 60.
Genentech has had a stellar run since last year's ASCO, when it first announced strong data for Avastin. The colorectal cancer drug blocks the growth of new blood vessels that nourish deadly tumors. The FDA on Feb. 26 approved Avastin for limited use.
This year, researchers also will present data from a study that combines Tarceva with Avastin. This early study has no control arm, so it won't change how doctors medicate patients. But it's significant because targeted cancer drugs are still given along with chemotherapy, which comes with side effects such as hair loss, vomiting and fever.
"This could be the first real non-chemo combination, which has never been done before," said Genentech's Clark. "It's data that might give clinicians hope of what could work in the future."
If a Tarceva-Avastin combo is just as effective as chemo without the side effects, it could mean a big quality of life improvement. But first must come the control studies, which could take years.
Merrill Lynch's Eric Ende has called Tarceva a possible blockbuster — the industry term for drugs that bring in more than $1 billion.
"But based on the current stock price and without the actual data, we would wait on the sidelines until we know that the survival benefit is clinically meaningful," Ende wrote this week.
Analysts say Tarceva will likely win FDA approval in early 2005.
Needham analyst Derrick Tang says he plans to watch for Telik's (NasdaqNM:TELK - News) phase two data on the Telcyta drug. It's being tested along with a traditional chemotherapy drug.
Most newly diagnosed patients are treated with a cocktail of drugs, so the best way to potentially grow market share is to study drugs in combination, he says. The drug is expected to enter late stage studies in the second or third quarter.
Tang says he's also looking for data on Cell Genesys' (NasdaqNM:CEGE - News) cancer vaccine. The company plans to start late stage studies this month.
William Blair analyst Winton Gibbons says he will keep his eye on Amgen (NasdaqNM:AMGN - News) and Abgenix's (NasdaqNM:ABGX - News) phase three results for their advanced colon cancer drug, Panitumumab.
At ASCO, Roche also will release details from its late stage study of Xeloda in colon cancer patients. Xeloda won FDA approval in May 2001 in patients with colon cancer that had spread through the body.
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