Genentech ( DNA) and OSI Pharmaceuticals ( OSIP) said early Monday that a late-stage study found that a combination of cancer drugs Avastin and Tarceva as a second-line treatment in patients with advanced non-small cell lung cancer failed to increase the overall survival rate. The "BeTa Lung" study looked at Avastin in combination with Tarceva in comparison to Tarceva alone in patients for whom chemotherapy had not stopped cancer progression. Avastin is approved as a first-line treatment in combination with chemotherapy for patients without the squamous form of non-small cell lung cancer, while OSI's Tarceva is approved a second line treatment. Genentech shares closed Friday at $87.53, while OSI shares closed at $45.84. Median survival in the Tarceva and placebo group was 9.2 months. The companies said the median survival in the combination arm was similar but did not give specific data. The full data will be presented at a U.S. conference in November. Notably, the median overall survival in the Tarceva arm was significantly longer than that the 6.7 months observed in the study for which the drug gained approval. Despite the lack of an overall survival improvement in the combination arm, the companies said there was "clear evidence" of improvement in the secondary endpoints of time without tumor progression and response rate. "We are disappointed this study did not show an improvement in survival for patients with advanced lung cancer who have a poor prognosis and a disease that is extremely difficult to treat," said Hal Barron, Genentech's development and chief medical officer.
"We are, however, encouraged to see the combination of Avastin and Tarceva had clear evidence of biological activity, and will fully analyze the data so that we can apply the insights to our ongoing lung cancer research," he said. Most Wall Street analysts didn't have the success of this trial factored into their estimates. "If, however, the trial had succeeded, we might have been able to raise Avastin estimates by $200
million to $300 million and Tarceva estimates by $50 million to $100 million," wrote Deutsche Bank analyst Mark Schoenebaum in a note to investors Monday morning. That would translate to a 10-cent to 25-cent addition to earnings per share, according to the analyst. Last spring, the Food and Drug Administration granted accelerated approval for Avastin (in combination with chemotherapy drug Taxol) as a first line treatment in metastatic breast cancer based on a progression-free survival benefit. The FDA's decision was somewhat controversial, as it went against the recommendation of its advisory panel, which voted 5 to 4 to suggest the agency not approve the drug. The panel's concern was based on the data available from a study in which the drug increased progression-free survival, but not overall survival, and added significant side effects. U.S. regulators went against that recommendation and granted the drug accelerated approval, which will be converted to a full approval upon submittal of additional data from two other Avastin breast cancer studies. One of these studies, dubbed AVADO, was a success earlier this year. The other study, RIBBON-1, will be completed later this year.
Data from a second NSCLC study, dubbed "ATLAS," evaluating an Avastin-Tarceva combination as a first-line maintenance treatment for advanced NSCLC patients should be available in the first half of 2009. That study will look at the combination in patients whose disease has not progressed following treatment with an Avastin-chemotherapy combination in the first half of 2009. Lung cancer is the single largest cause of cancer deaths among men and women in the U.S. and is responsible for nearly 30% of cancer deaths in the U.S., according to the American Cancer Society.