CHMP Recommends Approval of Obinutuzumab for Follicular Lymphoma

Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended obinutuzumab in combination with bendamustine for the treatment of patients with follicular lymphoma (FL) previously treated with chemotherapy. The European Commission is expected to make a final decision soon.

The CHMP recommendation is based on the results of the multi-center, open-label, phase III GADOLIN study of 413 patients with rituximab-refractory, indolent non-Hodgkin lymphoma (NHL); of these, 321 patients had FL. Patients were randomized to receive:

  • Obinutuzumab 1,000 mg administered intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of cycles 2-6 plus bendamustine 90 mg/m2 IV on days 2 and 3 of cycle 1 and on days 1 and 2 of cycles 2-6 (n=155; experimental)
  • Bendamustine 120 mg/m2 IV monotherapy on days 1 and 2 for 6 cycles (n=166; control)

After the six treatment cycles, patients in the experimental cohort received obinutuzumab every two months until disease progression or for a maximum of two years.

The median progression-free survival (PFS; the study’s primary endpoint) was not reached in the obinutuzumab cohort compared with 13.8 months for the control group. The median PFS was 29.2 months for the obinutuzumab combination cohort versus 13.7 months for bendamustine alone (hazard ratio [HR] = 0.48; 95% CI 0.35-0.67; p<0.0001). At a median follow-up of 24.1 months, the risk of death was reduced by 38 percent for those in the obinutuzumab combination cohort compared with the control group (HR=0.62; 95% CI 0.39-0.98). Patients in the obinutuzumab group experienced a 52 percent decreased risk of disease progression compared with bendamustine alone (HR=0.48; 95% CI 0.34-0.68; p<0.0001).

Neither study arm reached overall survival (the study’s secondary endpoint).

The most frequently reported serious AEs in the obinutuzumab cohort included febrile neutropenia, neutropenia, infusion-related reactions, sepsis, pneumonia, and pyrexia.

Obinutuzumab is already approved by the U.S. Food and Drug Administration in combination with bendamustine followed by obinutuzumab alone for the treatment of patients with rituximab-refractory/relapsed FL. It is also approved in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia.

Source: Roche press release, April 29, 2016.