Genentech announced that its Phase 3 CLL11 study met its primary endpoint demonstrating that obinutuzumab (GA101) plus chlorambucil helped patients with previously untreated chronic lymphocytic leukema live significantly longer without their disease worsening (progression-free survival; PFS) compared to Rituxan (rituximab) plus chlorambucil.
Obinutuzumab (GA101) is the first type II anti-CD20 medicine that is glycoengineered, which creates a unique antibody designed to act as an immunotherapy, engaging the patient’s own immune system to help attack the cancerous cells. In addition, GA101 binds to CD20 with the aim of inducing direct cell death.
CLL11 is a Phase 3, multicenter, open-label, randomized three-arm study investigating the efficacy and safety profile of either obinutuzumab plus chlorambucil or Rituxan plus chlorambucil compared to chlorambucil alone in 781 previously untreated people with CLL and co-existing medical conditions who are in need of therapy. The study included two stages of analysis.
- Stage 1 included 589 patients and compared obinutuzumab plus chlorambucil to chlorambucil alone and Rituxan plus chlorambucil to chlorambucil alone. Stage 1 results showed that obinutuzumab plus chlorambucil doubled the time people lived without their disease worsening compared to chlorambucil alone (23 months compared to 10.9 months, HR=0.14, 95% CI 0.09-0.21, P<.0001).
- Stage 2 enrolled an additional 192 patients to enable the final direct comparison of obinutuzumab vs. Rituxan, both in combination with chlorambucil.
Due to the significance of the positive trial results and the serious and life threatening nature of CLL, the FDA granted the GA101 application both Breakthrough Therapy Designation and Priority Review.
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