Strong results in MCL patients treated with Imbruvica

Janssen Research & Development announced results of a pooled analysis of relapsed/refractory (r/r) mantle cell lymphoma (MCL) patients treated with Imbruvica (ibrutinib). The extended follow-up data demonstrated that patients treated with Imbruvica earlier (after first relapse) experienced the best clinical outcomes, in terms of both efficacy and tolerability. The pooled analysis includes results from Phase II and III studies (SPARK, PCYC-1104, and RAY; n=370), and additional follow up of 87 patients across these studies who enrolled in the long-term open-label extension study, CAN3001.

Eighty-three patients were treated with Imbruvica for 3 or more years, and 40 patients were treated with Imbruvica for 4 or more years. With 3½ years (41 months) of follow up, the median progression free survival (PFS) overall was 13 months, and 33.6 (range, 19.4-42.1) months in patients with one prior line of therapy. The median PFS in patients achieving complete response (CR) was 46.2 (range, 42.1-not estimable) months and the duration of response in these patients was 55.7 (range, 55.7-NE) months. Patients with favorable baseline disease characteristics were more likely to remain on Imbruvica for more than 3 years.

Overall, 53% (95% CI, 0.47-0.58), 45% (0.39-0.50), and 37% (0.25-0.49) of patients were alive at 2, 3, and 5 years, respectively, and the median overall survival (OS) was 26.7 months. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 79.7% of patients, with the new onset events decreasing after the first year. New onset grade 3/4 TEAEs were generally less common in patients who were treated earlier with ibrutinib. In these studies that permitted enrollment of patients with multiple cardiac risk factors, and among patients experiencing grade 3/4 atrial fibrillation, no patients discontinued treatment and <1% had a dose reduction. These data were presented in an oral presentation at the 59th American Society of Hematology (ASH) Annual Meeting.