The randomized, 120-patient study compared the combinations of Avastin (bevacizumab) plus Tarceva (erlotinib), and Avastin plus chemotherapy, to chemotherapy alone in patients with recurrent or refractory non-small cell lung cancer (NSCLC).
The study evaluated three treatment regimens: Avastin in combination with Tarceva; Avastin in combination with chemotherapy (either pemetrexed or docetaxel); and chemotherapy alone (either pemetrexed or docetaxel).
Study data suggested that the median progression-free survival (PFS) was 4.8 months in the Avastin plus chemotherapy arm, and 4.4 months in the Avastin plus Tarceva arm, compared to three months in the chemotherapy-alone arm. The data also suggested that the Avastin plus chemotherapy arm reduced the risk of cancer progression or death by 34% compared to chemotherapy alone, and that the Avastin plus Tarceva arm reduced the risk of cancer progression or death by 28% compared to chemotherapy alone.
Due to the planned exploratory nature and small sample size of the study, these data do not provide definitive conclusions or reach statistical significance with respect to differences among the three treatment arms.
The estimated six-month survival rates – which represented the percentage of patients alive at six months – were 78% in the Avastin plus Tarceva arm, and 72% in the Avastin plus chemotherapy arm, compared to 62% in the chemotherapy-alone arm. One-year survival data are not yet mature.
“We are encouraged that these findings support the hypothesis that combining therapies that target different cancer pathways, such as angiogenesis and epidermal growth factor receptor (EGFR) signaling, may improve progression-free survival, possibly without the use of chemotherapy,” said Dr Hal Barron, senior vice president of development and chief medical officer at Genentech.
“Additional research is needed to further explore the safety and efficacy of Avastin in combination with Tarceva in advanced cancers, and we are currently conducting randomized phase III trials of this combination in relapsed and first-line NSCLC patients.”