Imbruvica ibrutinib: Phase III data

The open-label, international Phase III RAY (MCL3001) trial in 280 patients with relapsed or refractory MCL who have received >=1 prior Rituxan rituximab-containing chemotherapy regimen showed that once-daily 560 mg oral Imbruvica met the primary endpoint of improving median PFS vs. IV Torisel temsirolimus (14.6 vs. 6.2 months, HR=0.43, 95% CI: 0.32, 0.58, p<0.0001). Imbruvica led to a 2-year PFS rate of 41% vs. 7% for Torisel. Additionally, Imbruvica led to an ORR of 72%, including 26 complete responses, vs. 40% for Torisel, including 2 complete responses (p<0.0001). The median time to next treatment was not reached with Imbruvica vs. 11.6 months for Torisel (p<0.0001) and the median treatment duration was 14.4 months for Imbruvica vs. 3 months for Torisel. Median OS was not reached with Imbruvica vs. 21.3 months for Torisel. Data were published in The Lancet and presented at the American Society of Hematology meeting in San Francisco. ...