ZURICH, June 3 (Reuters) – Swiss drugmaker Roche Holding AG (ROG.VX) has stopped enrolling patients into a late stage trial for Avastin and MabThera plus a type of chemotherapy in non-aggressive non-Hodgkin’s Lymphoma, dealing the group a blow.
The news is the latest setback for Avastin this year after it failed to help with prostate and gastric cancer in studies and casts a shadow over the group ahead of ASCO, the biggest annual cancer meeting, which starts on Friday in Chicago.
An independent data and safety monitoring board recommended the group halt enrolment into the Phase III trial, which was evaluating the efficacy and safety of Avastin when added to MabThera and CHOP chemotherapy in patients with Diffuse Large B-Cell Lymphoma, Roche said on Thursday.
Data from a recent safety and efficacy analysis of the first 720 patients enrolled into the study showed the benefits of adding Avastin to the standard of care treatment MabThera plus CHOP did not outweigh the risks, Roche said.
Roche, the world’s largest maker of cancer drugs, said the news did not affect Avastin, its biggest seller, in approved indications and the broad development programme of the drug would continue as planned.
Separately on Thursday, Roche said a late-stage trial had shown the superiority of its drug CellCept over azathioprine to treat Lupus Nephritis.
Vifor Pharma, the pharma business of the Galenica Group (GALN.S), is developing the drug with Roche. The two groups are now looking at the potential to seek regulatory approval in the United States, Europe and other markets. (Reporting by Katie Reid; Editing by Hans Peters)
