GA101 succeeds in Phase III
17.05.2013 - Roche’s glyco-optimised anti-CD20 antibody obinutuzumab (GA101) significantly reduced the risk of disease in patients with leukaemia (CCL).
According to the first results from Roche/Genentech’s Phase III-CLL11, GA101 plus chlorambucil therapy more than doubled progression-free survival (PFS) of treatment-native chronic lymphocytic leukaemia (CCL) patients (23 months compared to 10.9 months, HR=0.14, 95% CI 0.09-0.21, p <.0001) compared to the chemotherapeutic chlorambucil alone. The combination therapy with chlorambucil demonstrated a significant 86% reduction in the risk of disease progression, relapse or death. Full data will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on 4th June.
In the third arm of the trial including 192 patients, Roche compares the efficacy of the type-II-anti-CD20 antibody GA101 versus its type-I-anti-CD20 blockbuster MabThera (rituximab) both in combination with chlorambucil. According to Roche GlycArt’s head, Pablo Umaña, GA101 has been glyco-optimised to show improved antibody-dependent cellular cytotoxicity and direct cytotoxicity. Roche said that at this time, no formal comparison between the GA101 and MabThera/Rituxan arms can be made as the number of PFS events required for that formal analysis has not yet been reached. However the company has filed for market authorisation in the US and the EU based on the CLL11 study.
CLL is one of the most common forms of blood cancer and each year it causes approximately 75,000 deaths across the globe. The CLL11 study included elderly people with previously untreated CLL who were often not able to tolerate existing aggressive treatment options. According to Roche, no new safety signals were detected for either GA101 or MabThera/Rituxan. The most common severe adverse events for GA101 were infusion-related reactions (IRRs) and low cell counts of neutrophile (neutropenia).