Date: 2012-06-03
Type of information:
phase: 3
Announcement: results
Company: Roche (Switzerland)
Product: Avastin® (bevacizumab)
Action mechanism: Avastin® is an antibody that precisely targets and inhibits vascular endothelial growth factor (VEGF)for continuous tumour control. Avastin’s precise VEGF inhibition allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.
Disease: metastatic colorectal cancer (mCRC)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: ML18147 was a randomised, open-label phase III multicentre, multinational trial evaluating the efficacy and safety profile of Avastin plus standard second-line chemotherapy in 820 patients with mCRC whose disease had progressed following Avastin plus standard first-line chemotherapy (irinotecan or oxaliplatin-based).
Patients were randomised at progression to one of two treatment arms:
• Arm A: Chemotherapy* plus Avastin (equivalent of 2.5 mg/kg i.v. per week)
• Arm B: Chemotherapy* alone
*Depending on the first-line chemotherapy backbone (fluoropyrimidine / irinotecan-based or fluoropyrimidine / oxaliplatin-based)
the chemotherapy backbone was switched in the second-line setting.
The primary endpoint of the study was overall survival measured from the time patients were randomised to the second-line treatment. The secondary efficacy endpoints of the study included PFS, overall response rate and safety profile.
Latest
news: Roche has announced results from ML18147, a phase III 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 percent for people who continued with Avastin® plus second-line chemotherapy compared with those who received chemotherapy alone (HR = 0.81, p = 0.0062). People who continued with Avastin® plus second-line chemotherapy also experienced a significant improvement in progression free survival (PFS, the time a person lives without the disease getting worse); the risk of their cancer progressing was reduced by 32 percent (HR = 0.68, p<0.0001). Adverse events in ML18147 were consistent with those seen in previous pivotal trials of Avastin across tumour types.
ML18147 Study Results
• 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 randomised to the second-line treatment.
