Imbruvica ibrutinib: Additional Phase III data

Additional data from the double-blind, international Phase III HELIOS (CLL3001) trial in 578 CLL or SLL patients who received >=1 line of prior systemic therapy showed that median PFS, the primary endpoint, has not yet been reached for once-daily 420 mg oral Imbruvica plus Treanda bendamustine and Rituxan rituximab vs. 13.3 months for placebo plus Treanda and Rituxan (HR=0.203, 95% CI: 0.15, 0.276, p<0.0001). Imbruvica plus Treanda and Rituxan led to an 18-month PFS rate of 79% vs. 24% for placebo plus Treanda and Rituxan. Additionally, Imbruvica plus Treanda and Rituxan led to a greater ORR (82.7% vs. 67.8%, p<0.0001) and complete response rate (10.4% vs. 2.8%) at a median follow-up of 17 months vs. placebo plus Treanda and Rituxan. Median OS has not yet been reached. Data were presented at the American Society of Clinical Oncology meeting in Chicago. In March, top-line data showed that Imbruvica plus Treanda and Rituxan met the primary endpoint of improving PFS vs. placebo plus Treanda and Rituxan. Based on the data, an independent DMC recommended unblinding the data (see BioCentury, March 23). ...