Roche announced new Phase II efficacy data from the investigational compound GA101 ( RG 1759 ) in relapsed/refractory non-Hodgkin’s lymphoma ( NHL ).
GA101 is the first type II, glycoengineered anti-CD20 monoclonal antibody that has been specifically designed to enhance the destruction of cancerous B-cells either by activating other immune cells to attack the cancer cells or by inducing direct cell death.

The results showed promising response rates in very difficult-to-treat patients with either indolent or aggressive non-Hodgkin’s lymphoma who had failed multiple prior treatments, including prior treatment with Rituximab ( MabThera, Rituxan ).

The efficacy data presented came from two Phase II dose-finding studies of GA101 in relapsed or refractory patients with either indolent or aggressive non-Hodgkin’s lymphoma.

In the first Phase II study in aggressive NHL, patients had received a median of 3 prior therapies and 63% had not responded to or had disease progression within 6 months of Rituximab. Nearly a third of patients responded to treatment with GA101 ( 11 of 40 patients, 24% in the 400 mg cohort, 32% in the 1600/800 mg cohort ). For patients no longer responding to Rituximab, response rate was 25% in the 1600/800 mg cohort.

In the second Phase II study in relapsed/refractory indolent non-Hodgkin’s lymphoma, patients had received a median of 3 prior treatment and 55% had not responded to or had disease progression within 6 months of Rituximab. In the overall indolent non-Hodgkin’s lymphoma population, which was heavily pre-treated, 55% of patients responded to treatment with GA101 with a promising median progression-free survival ( PFS ) of 11.3 months in the 1600/800 mg cohort ( in the 400 mg cohort, there was a 17% response rate with 6 months of median PFS ). For patients no longer responding to Rituximab, response rate in the 1600/800 mg cohort was 50%.

Source: 52nd Annual Meeting of the American Society of Hematology, 2010

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