Ofatumumab + Chlorambucil Versus Chlorambucil Alone
Hillmen P, Robak T, Janssens A, et al.
Key Points:
- Phase III study evaluating Ofatumumab + Chlorambucil (O+Chl) vs. Chlorambucil alone in elderly CLL patients
- Primary endpoint: progression-free survival (PFS)
- Secondary endpoints: overall response rate (ORR), overall survival (OS) and safety.
- O+CHL vs CHL: significantly prolonged PFS (22.4 vs 13.1 months); higher ORR (82% vs 69%); superior CR (12% vs 1%)
- Grade ≥3 AEs: 50% O-CHL vs 43% CHL; includes: neutropenia
- Deaths during treatment occurred in 2% of subjects in both arms.
Implications:
- Ofatumumab + chlorambucil (O+CHL) demonstrated clinically important improvements with manageable side effect profile in patients with CLL who have not received prior therapy and who are considered inappropriate for fludarabine based therapy.
View the original abstract on the ASH website.
