NEW ORLEANS -- The use of Tarceva boosted survival by 42% in patients with end-stage non-small-cell lung cancer, according to clinical data presented Saturday at the annual meeting of the American Society of Clinical Oncology (ASCO).
In late April, Tarceva partners OSI Pharmaceuticals (OSIP:Nasdaq) and Genentech (DNA:NYSE) announced that the drug's phase III study was a success. But the actual survival data were kept under wraps for presentation at the ASCO meeting. Shares of OSI have more than doubled since the companies made that announcement in April.
OSI is expected to seek marketing approval for Tarceva from the Food and Drug Administration this summer. The drug, once approved, would be co-marketed by OSI and Genentech in the U.S. Swiss drugmaker Roche would handle international marketing duties.
The phase III Tarceva study enrolled 731 non-small-cell lung cancer patients who failed all approved drugs and had no other good medical treatment options. These patients were split into two groups: One group was given Tarceva, while the other group (the control) was treated with the standard "best supportive care." The study's main goal, or primary endpoint, was designed to show that Tarceva could improve overall survival by about 33%.
The study achieved this goal, and then some. The 488 patients in the study given Tarceva had a median survival of 6.7 months, compared with 4.7 months for the 243 patients receiving standard of care. The difference in survival was two months, or 42%, and statistically significant.
"This is a new, well-tolerated oral treatment for patients who previously had very few options," said Dr. Frances Shepherd, an oncologist at the Princess Margaret Hospital in Toronto and the lead investigator of the study, in a statement. "Patients treated with erlotinib [Tarceva] in our trial not only lived longer, but they also had a better quality of life."
Generally speaking, Wall Street's biotech fund managers were hoping to see a minimum of a 40%, or two-month, improvement in survival.
An oral drug, Tarceva is a member of the closely watched class of drugs that attempts to halt the growth of cancer cells by blocking a key enzyme, epidermal growth factor, or EGF. In this way, Tarceva is very similar to AstraZeneca's (AZN:NYSE) Iressa, the first of these EGF inhibitors to be approved in the U.S., also for late-stage non-small-cell lung cancer patients. ImClone's (IMCL:Nasdaq) Erbitux is also an EGF inhibitor, but it's an injectable drug, so it works in a slightly different way.
Wall Street's sales estimates for Tarceva in non-small-cell lung cancer are wide ranging, from $500 million to well above $1 billion -- although such projections are mere guesses, since the drug is not yet approved.
The consensus view is that Tarceva will likely be viewed by many doctors as superior to AstraZeneca's Iressa. That's because the Tarceva study is the first controlled study of an oral EGF inhibitor drug to demonstrate that it can boost the survival of advanced non-small-cell lung cancer patients.
Iressa was approved on the basis of uncontrolled studies that showed the drug shrank tumors in about 10% of patients; the studies were not designed to look at changes in patient survival. Last year, AstraZeneca reported worldwide Iressa sales of $228 million.
Interestingly, in the Tarceva study, only 8.9% of patients responded (had their tumors shrink by 50% or more). That's a lower patient response rate than what AstraZeneca showed with Iressa in its studies -- a 10% patient response rate. AstraZeneca is currently conducting controlled studies to determine how well Iressa boosts survival in late-stage non-small-cell lung cancer patients. The fact that Iressa's response rate was higher than that for Tarceva may lead some to predict that Iressa might also produce a stronger survival benefit. A definitive answer will have to wait until the studies are complete.
OSI shares closed Friday at $78.53, up $1.53, or 2%; Genentech shares closed at $59.61, down 49 cents, or 0.82%.
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