Roche’s bid to extend usage of Avastin have taken a knock with the news that the Swiss major has stopped enrolling patients into a late-stage trial for aggressive non-Hodgkin’s lymphoma using the oncology blockbuster.
The Basel-headquartered firm says it has accepted the recommendation of an independent data and safety monitoring board to stop enrolment into the MAIN trial. The Phase III study was evaluating Avastin (bevacizumab) when added to MabThera/Rituxan (rituximab) plus CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone) chemotherapy in patients with diffuse large B-cell lymphoma (DLBCL).
The DSMB’s recommendation is based on data from an analysis of the first 720 patients enrolled into the MAIN study, “which showed an unfavorable risk-benefit assessment of the addition of Avastin to the standard of care treatment”, ie MabThera plus CHOP. An assessment of whether there was a higher occurrence of known safety events of the Avastin combo, where anthracyclines were given at relatively high cumulative dose, is ongoing.
The company says that these findings do not impact Avastin’s approved indications and says it is “fully committed to developing new therapies for patients with aggressive NHL”. The last couple of months have seen Avastin fail in late-stage trials as a potential treatment for both late-stage prostate and stomach cancers.
