Roche bares non-Hodgkin's lymphoma study results

ORLANDO, Florida — Roche announced recently new Phase II efficacy data from the investigational compound GA101 (RG 1759) in relapsed/refractory non-Hodgkin’s lymphoma (NHL), a common type of blood cancer.

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 NHL who had failed multiple prior treatments, including prior treatment with rituximab.

The data were presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.

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

In the first Phase II study in aggressive NHL (Abstract #2878), patients had received a median of three prior therapies and 63 percent had not responded to or had disease progression within six months of rituximab.

Nearly a third of patients responded to treatment with GA101 (11 of 40 patients, 24 percent in the 400 mg cohort, 32 percent in the 1600/800 mg cohort). For patients no longer responding to rituximab response rate was 25 percent in the 1600/800 mg cohort.

In the second Phase II study in relapsed/refractory indolent NHL (Abstract #2868), patients had received a median of three prior treatment and 55 percent had not responded to or had disease progression within six months of rituximab.

In the overall indolent NHL population, which was heavily pre-treated, 55 percent 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 percent 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 percent.

“We are pleased to share these new Phase II data on GA101 at the ASH meeting” said Dr. Hal Barron, head of global development and chief medical officer at Roche.

“The performance of GA101 in this difficult-to-treat group of patients with NHL is encouraging, and we look forward to sharing more data from the extensive GA101 clinical development program in future,” Barron added.