'Data from this study show that Avastin may have the potential to become an important new treatment option for patients diagnosed with non-small cell lung cancer.'

Patients receiving Avastin with the chemotherapy combination had a 30 percent improvement in overall survival (or a hazard ratio of 0.77, which can also be referred to as a 23 percent reduction in the risk of death), compared to patients who received chemotherapy alone. Median survival of patients treated with Avastin plus chemotherapy was 12.5 months, compared to 10.2 months for patients treated with chemotherapy alone.

The data were featured in a press briefing at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).

Improvement in Progression-Free Survival

"The results of this Phase III study reveal, for the first time, an improvement in survival with the addition of a targeted biologic agent to standard chemotherapy in this patient population, and the first time median survival has been extended beyond one year in advanced lung cancer," said Alan B. Sandler, M.D., of Vanderbilt University Medical Center in Nashville, who will present full results of the study on Saturday.

"We also observed improvements in other measures of patient benefit, including progression-free survival and tumor-response rate," Dr. Sandler added.

This study showed a 61 percent improvement in progression-free survival (or a hazard ratio of 0.62, which can also be referred to as a 38 percent reduction in the risk of progression).

Median progression-free survival was 6.4 months for patients treated with Avastin plus chemotherapy, compared to 4.5 months for patients treated with chemotherapy alone. The response rate in patients with measurable disease was 27 percent (97/357) in the group receiving Avastin plus chemotherapy, compared to 10 percent (35/350) in the group receiving chemotherapy alone.

Risk of Pulmonary Bleeding

In previous clinical experience with Avastin in combination with paclitaxel and carboplatin in NSCLC, patients with a specific type of NSCLC called "squamous cell carcinoma" had a higher risk of experiencing life-threatening or fatal pulmonary bleeding. These patients were excluded from this Phase III study and the rate of life-threatening or fatal pulmonary bleeding in patients treated with Avastin was substantially reduced from prior clinical studies.

A preliminary assessment of adverse events by the investigators showed that Grade 3/4/5 bleeding occurred in 4.5 percent of patients in the Avastin plus chemotherapy arm, compared to 1 percent of patients in the chemotherapy alone arm. Treatment-related deaths occurred at a rate of 2 percent (8/420) in the Avastin plus chemotherapy arm, compared to less than 1 percent (2/427) in the chemotherapy alone arm. Fatal (Grade 5) hemoptysis occurred at a rate of 1 percent (5/420) in the Avastin plus chemotherapy arm.

Common Adverse Events

The preliminary safety assessment showed that the most common adverse events were neutropenia, hypertension and thrombotic events. Grade 3/4 neutropenia occurred in 24 percent of patients treated with Avastin plus chemotherapy and 16 percent of patients who received chemotherapy alone.

Hypertension occurred in 6 percent of patients who received Avastin plus chemotherapy and 1 percent of patients who received chemotherapy alone. Grade 3/4 venous thrombosis occurred in 4 percent of patients treated with Avastin plus chemotherapy, compared with 3 percent of patients treated with chemotherapy alone. Grade 3/4 arterial thrombosis occurred in 2 percent of patients treated with Avastin plus chemotherapy, compared with 1 percent in patients treated with chemotherapy alone.

"Data from this study show that Avastin may have the potential to become an important new treatment option for patients diagnosed with non-small cell lung cancer," said Hal Barron, M.D., Genentech's senior vice president, development, and chief medical officer.