Arzerra ofatumumab: Phase III data

The open-label, international Phase III Study 119 in 261 CLL patients who progressed <=24 months after receiving >=2 cycles of a purine analog or Treanda bendamustine showed that twice-daily 150 mg oral Zydelig idelalisib plus 12 infusions of IV Arzerra ofatumumab over 24 weeks met the primary endpoint of improving median PFS vs. Arzerra alone (16.3 vs. 8 months, HR=0.27, 95% CI: 0.19, 0.39, p<0.0001). Zydelig plus Arzerra also met the secondary endpoints of improving ORR (75% vs. 18%, p<0.0001) and lymph node response rate (93.3% vs. 4.9%, p<0.0001) vs. Arzerra alone. The combination missed the secondary endpoint of improving median OS vs. Arzerra alone (20.9 vs. 19.4 months, HR=0.74, p=0.27). Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...