Genentech announced results from ML18147, a Phase 3 study in metastatic colorectal cancer (mCRC) that evaluated Avastin (bevacizumab) continued with second-line chemotherapy in people who received initial Avastin plus first-line chemotherapy.
The study met its primary endpoint of a significant increase in overall survival (OS). In the study, the relative risk of death was reduced by 19% for people who continued with Avastin plus second-line chemotherapy compared to those who received chemotherapy alone. People who continued with Avastin plus second-line chemotherapy also experienced a significant improvement in progression-free survival; the risk of their cancer progressing was reduced by 32%. Adverse events were consistent with those seen in previous pivotal trials of Avastin across tumor types.
“Our study design was based on previous research showing that sustained VEGF inhibition achieved and maintained anti-tumor activity,” said Hal Barron MD, chief medical officer and head, Global Product Development. “While conventional practice is to change treatment completely at disease progression, the continued use of Avastin with a new chemotherapy regimen in this study resulted in patients living longer, compared to a new chemotherapy regimen alone.”
People with mCRC who received Avastin in combination with standard chemotherapy in both the first- and second-line settings had a median OS of 11.2 months compared to 9.8 months for people who received chemotherapy alone. Median PFS was 5.7 months compared to 4.1 months. OS and PFS were calculated from the time patients were randomized to the second-line treatment.
Select AEs (Grade 3-5) that occurred more often in the Avastin arm compared to the chemotherapy alone arm after randomization were high blood pressure (2% vs. 1%), bleeding (2% vs. <1%), gastrointestinal perforations (a hole in the stomach or intestine; 2% vs. <1%) and blood clots in the vein (5% vs. 3%).
Release Date: June 2, 2012
Source: Genentech
Filed Under: Drug Discovery
