Roche’s MabThera successor shows phase II promise
pharmafile | December 6, 2010 | News story | Research and Development, Sales and Marketing | GA101, Genentech, GlycArt, MabThera, Roche, blood cancer, chronic lymphocytic leukaemia
The cancer drug Roche is developing as a second-generation successor to its blockbuster MabThera has shown promising results in a phase II trial.
Presented at the American Society of Hematology, the data demonstrated efficacy in hard-to-treat patients with the blood cancer non-Hodgkin’s lymphoma (NHL).
Roche announced two years ago that it would bring investigational compound GA101, developed by its wholly-owned biotech company GlycArt, to market.
It is the first type II, glyco-engineered anti-CD20 monoclonal antibody to enter clinical trials in NHL and chronic lymphocytic leukaemia (CLL).
GA101 is being investigated in a number of phase III studies, including head-to-head trials against MabThera.
It has been designed with the sole aim of destroying cancerous B-cells, by either activating other immune cells to attack the unwanted cells or by killing them directly.
Glyco-engineering is designed to make a molecule more potent, active in the body for longer and to cause fewer unwanted side-effects.
In the first phase II study in aggressive NHL, patients had received three prior therapies and 63% had not responded to – or had disease progression within six months of – MabThera.
Nearly a third responded to treatment with GA101 (11 of 40 patients, 24% in the 400mg cohort, 32% in the 1600/800mg cohort).
For patients no longer responding to MabThera, the response rate was 25% in the 1600/800mg cohort.
In the second study, this time in relapsed/refractory indolent NHL, patients had also received three prior treatments and 55% had not responded or their conditioned had worsened with MabThera.
In the overall indolent NHL population, which was heavily pre-treated, 55% of patients responded to treatment with GA101.
Median progression-free survival (PFS) in these cases was 11.3 months in the 1600/800mg cohort, while in the 400mg cohort there was a 17% response rate with six months of median PFS.
For patients no longer responding to MabThera, response rate in the 1600/800mg cohort was 50%.
Hal Barron, chief medical officer at Roche, described the data as “encouraging” and said there would be more “from the extensive GA101 clinical development program in future”.
Adam Hill
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