Tarceva avastin combo shows promise

[RandyW]

ATLANTA (MarketWatch) -- A small study suggested that combining the cancer drugs Avastin and Tarceva could be more effective than chemotherapy in treating people with a form of lung cancer.

Researchers say the study seems to lend support to the relatively new concept of combining so-called targeted therapies, which generally have been prescribed either alone or with chemotherapy. Targeted therapies are designed to focus on cancer cells, while older chemotherapy regimens can also attack healthy cells.

Avastin currently is marketed in the U.S. by Genentech Inc. (DNA), South San Francisco, Calif., as a first-line treatment for metastatic colorectal cancer in combination with chemotherapy. It's marketed outside the U.S. by Roche Holding AG (RHHBY) of Switzerland, which is the majority owner of Genentech. The companies are studying Avastin in numerous other cancer types, and some doctors already prescribe it in other cancers.

Tarceva is approved to treat patients with locally advanced or metastatic non-small-cell lung cancer after failure of at least one prior chemotherapy regimen, and in combination with chemotherapy for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. It's co-marketed in the U.S. by Genentech and OSI Pharmaceuticals Inc. (OSIP), Melville, N.Y., and outside the U.S. by Roche.

The new Phase II study involved about 120 patients grouped into three different treatments: Avastin combined with Tarceva, Avastin combined with chemotherapy and chemotherapy alone. The study tracked progression-free survival, which is the time it takes before either new tumor growth or death.

The study found that median progression-free survival was 4.4 months in the Avastin-Tarceva patients; 4.8 months in the Avastin-plus-chemotherapy arm; and three months in those getting chemotherapy alone, according to a press release from Genentech and OSI Pharmaceuticals. The data also suggested the Avastin-chemotherapy arm reduced the risk of cancer progression or death by 34% compared to chemotherapy alone, and the Avastin-plus-Tarceva reduced the risk of cancer progression or death by 28% compared to chemotherapy.

The combination therapy of Avastin plus Tarceva resulted in fewer serious adverse events compared to either chemotherapy-containing arm, the companies said. The rate of fatal pulmonary hemorrhage was consistent with previous Avastin trials in non-small-cell lung cancer.

The results were presented Monday at the annual meeting of the American Society of Clinical Oncology, a gathering of cancer specialists in Atlanta.

The companies cautioned that the new data doesn't provide definitive conclusions or reach statistical significance in the differences among the three treatment arms, citing "the planned exploratory nature and small sample size of the study."

A Phase III trial of the Avastin-Tarceva combination in relapsed and first-line non-small-cell lung cancer patients is underway.

"If the trends continued in a well-powered trial, it would be a nice result," said Louis Fehrenbacher, an oncologist with Kaiser Permanente in Vallejo, Calif., who presented the data here Monday.

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