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ATLAS: Adding erlotinib to bevacizumab for maintenance therapy improved PFS in NSCLC
2009 ASCO Annual Meeting
Adding erlotinib to bevacizumab after chemotherapy with bevacizumab alone reduced the risk of disease progression by 29% in patients with locally advanced, recurrent or metastatic non-small cell lung cancer in the first-line setting, according to an interim analysis from the phase-3b ATLAS trial.
The trial was stopped at its second interim analysis because it had met its primary efficacy endpoint.
“We did not see any new safety signals in this study,” Vincent A. Miller, MD, associate attending physician on the Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, said during his presentation at the 2009 ASCO Annual Meeting. “This is a relatively well-tolerated combination that did not present any novel toxicities.”
The randomized, placebo-controlled, double blind study included 768 patients with stage IIIb/IV or recurrent NSCLC. Three-hundred seventy patients were randomly assigned erlotinib (Tarceva, OSI Pharms) plus bevacizumab (Avastin, Genentech) and 373 were assigned placebo plus bevacizumab.
All patients had already received four cycles of chemotherapy with bevacizumab without disease progression or toxicity requiring bevacizumab by discontinued. The primary endpoint was PFS; secondary endpoints included OS, safety and biomarker analyses.
Median PFS was higher in the erlotinib group compared with placebo (4.76 months vs. 3.75 months; HR=0.722; 95% CI, 0.592-0.881). At three months, 67.7% of patients assigned erlotinib were free of progression compared with 53.4% of those assigned placebo. Similarly, at six months 40.3% of patients assigned erlotinib were free of progression compared with 28.4% of those assigned placebo.
The safety profile for erlotinib plus bevacizumab was consistent with profiles for both agents alone. According to Miller, survival data were not mature at the time of the analysis, but he and his colleagues expect these data will become available later in 2009.
“Biomarker analyses are ongoing and we think the future of this and other work is getting these combinations of targeted therapies to subgroups of patients who would benefit most at the earliest possible time in the course of their illness,” Miller said. – by Stacey L. Adams
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