First results of the study CLL11
The German CLL Study Group (GCLLSG) announced the first results from CLL11, a phase III study which is being conducted in collaboration with Hoffmann-La Roche. The CLL11 study compared the combination of either GA101 or rituximab and chlorambucil, a standard chemotherapy, to chlorambucil alone in elderly patients with chronic lymphocytic leukemia (CLL). CLL is one of the most common forms of blood cancer and the majority of patients diagnosed with this disease are of advanced age. Many of these have concurrent diseases and therefore may not tolerate more aggressive therapy which is the standard in younger patients. The CLL11 study included elderly people with previously untreated CLL and coexisting medical conditions (comorbidities).
“So far, conclusive evidence that treatments currently available for elderly CLL patients with comorbidities are superior to chlorambucil monotherapy has been lacking. This is the first direct comparison of chlorambucil monotherapy to a combination regimen of chlorambucil plus GA101 or rituximab”, said Dr Valentin Goede, a hematologist of the GCLLSG and the Principal Investigator of the CLL11 trial. “Based on the results we have seen, elderly CLL patients with comorbidities and treated with chlorambucil should also receive a CD20 antibody to improve the outcomes of their treatment”.
GA101 combined with chlorambucil demonstrated a significant 86% reduction in the risk of disease progression, relapse or death. Additionally, the length of time during which people lived without their disease worsening (median progression-free survival, PFS) was more than doubled (23 months compared to 10.9 months, HR=0.14, 95% CI 0.09-0.21, p <.0001) when compared to chlorambucil alone. Rituximab combined with chlorambucil demonstrated a significant 68% reduction in the risk of disease progression, relapse or death. The PFS was significantly increased (15.8 months compared to 10.8 months, HR=0.32, 95% CI 0.24-0.44, p <.0001) when compared to chlorambucil alone.
“To draw final conclusions on the efficacy and safety of combined treatment with GA101 with chlorambucil relative to rituximab plus chlorambucil in this particular patient population, results of the comparison of the two antibody arms of the CLL11 study will be important. These will be available soon,” said Prof Michael Hallek, Director of the Department I of Internal Medicine at the University Hospital Cologne and Head of the GCLLSG.
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