Roche halts Avastin lymphoma trial on negative risk:benefit ratio
This article was originally published in Scrip
Roche has halted a Phase III trial looking at the efficacy of Avastin (bevacizumab) when added to Roche/Biogen Idec's MabThera (rituximab) plus CHOP (cyclophosphamide plus doxorubicin plus vincristine plus prednisone) chemotherapy in patients with diffuse large B-cell lymphoma (DLBCL).
The decision to halt enrolment and stop dosing patients with Avastin is based on interim data that showed "an unfavourable risk-benefit assessment", said the company. It added that No new safety events had been identified, and an assessment of whether there was a higher occurrence of known safety events of Avastin in combination with the R-CHOP regimen in the MAIN trial (where anthracyclines were given at a relatively high cumulative dose) was ongoing.
The MAIN trial had enrolled over 720 patients with CD20-positive DLBCL, out of an originally planned 1,000 patients. Initiated in 2007, it was not due to complete until 2016.
The primary endpoint of the study was progression-free survival. Secondary endpoints include safety profiles of treatment arms, overall survival, event-free survival, overall and complete response rates.
These findings do not impact Avastin's approved indications, which include metastatic colorectal cancer, non-small cell lung cancer, breast cancer and renal cancer. The VEGF receptor antagonist is in development for around 30 different tumour types, in over 450 clinical trials.
Other drugs in development for the aggressive disease include Lilly's protein kinase C beta inhibitor enzastaurin and Immunomedics' CD22 antagonist epratuzumab, both of which are in Phase III development for this indication.