Tarceva Lifts Lung Cancer Survival Rate by 42%

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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) and Genentech(DNA) 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."