Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended approval for ofatumumab in combination with fludarabine and cyclophosphamide for patients with relapsed chronic lymphocytic leukemia (CLL).
The decision was based on the results of the phase III COMPLEMENT-2 study that demonstrated a median progression-free survival (PFS; primary endpoint) of 28.9 months for treatment with ofatumumab plus fludarabine and cyclophosphamide (combination group; n=183) compared with 18.8 months with fludarabine and cyclophosphamide alone (control group; n=182; hazard ratio [HR] = 0.67; 95% CI 0.51-0.88; p=0.0032).
Duration of response also was longer among patients treated with the combination therapy (29.6 months vs. 24.9 months; HR=0.77; 95% CI 0.56-1.05; p=0.0878). Time to progression also was shorter among those who received the combination therapy (42.1 months vs. 6.8 months; 6.8 months; HR=0.63; 95% CI 0.45-0.87; p=0.0036).
Overall survival (secondary endpoint) was not improved with the combination therapy (56.4 months vs. 45.8 months; HR=0.78; 95% CI 0.56-1.09; p=0.1410).
The most common treatment-related adverse events (AEs) associated with ofatumumab included neutropenia, thrombocytopenia, anemia, nausea, leukopenia, vomiting, pyrexia, rash, fatigue, and pneumonia. The rate of grade ≥3 AEs was 74 percent for those receiving combination therapy compared with 69 percent in the control cohort.
Source: Genmab press release, November 10, 2016.