Imbruvica (ibrutinib) prolongs PFS and ORR in patients with Mantle Cell Lymphoma compared to temsirolimus.- AbbVie + Janssen Biotech

AbbVie announced results from the Phase III RAY (MCL3001) trial, which showed Imbruvica (ibrutinib) significantly prolonged progression-free survival (PFS; the primary endpoint) and improved overall response rates (ORR; a key secondary endpoint) in patients with relapsed or refractory mantle cell lymphoma (MCL), compared with temsirolimus. Notably, Imbruvica was associated with a 57% reduction in the risk of progression or death with a median follow-up of 20 months. These data were published online in The Lancet and presented in an oral session at the 57th Annual American Society of Hematology (ASH) Meeting and Exposition in Orlando, FL. Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company, and Janssen Biotech, Inc.

Mantle cell lymphoma is an aggressive form of blood cancer which arises from B cells, a type of white blood cell (lymphocyte) that originates in the bone marrow. MCL is more prevalent in men than women. The majority of patients are in their mid-60s at diagnosis and the median overall survival rate is three to four years. Imbruvica significantly improved PFS as determined by an Independent Review Committee (IRC) compared to treatment with temsirolimus, resulting in a reduction in the risk of disease progression or death by 57% after a median follow-up of 20 months (HR 0.43 [95% CI, 0.32-0.58; P<0.0001]). The median PFS for Imbruvica-treated patients was 14.6 months compared to 6.2 months for patients treated with temsirolimus. Imbruvica was associated with a significantly higher ORR versus temsirolimus as assessed by an IRC (72% vs. 40%, respectively; difference 31.­5% [95% CI, 20­.5–42.­5]; p<0­0001). Twenty-six patients who received Imbruvica (19%) achieved a complete response (CR), while only two patients who received temsirolimus experienced a CR (1%). Of note, the median treatment duration was four times longer in patients taking Imbruvica than those receiving temsirolimus (14.4 months vs. 3.0 months, respectively). Median overall survival was not reached with Imbruvica, as compared to 21.3 months with temsirolimus (HR, 0.76; [95% CI, 0.53-1.09). These findings are consistent with results from previous single-arm Phase II studies evaluating the safety and efficacy of Imbruvica in patients with MCL.