美国血液学年会Post-ASH CLL.pptx

Chronic Lymphocytic Leukemia and Other B-Cell Malignancies Key updates CLL Development Plan: Ibrutinib in Relapsed/Refractory CLL PCYC-1102 Phase 1b/2 monotherapy (Closed) 71% ORR in the 420 mg/day cohort (2 CR, 34 PR)1 71% ORR in the 840 mg/day cohort (24 PR) 1 10 (20%) and 5 (15%) in the 420 mg/day and the 840 mg/day cohort had PR + L1 No significant difference in ORR by subset analyses except for IgVH1 26-month PFS and OS: 75% and 83%1 AEs were modest and as expected Most common grade 3 AE was neutropenia1 PCYC-1112 RESONATE™Phase 3 ibrutinib vs. ofatumumab (Enrollment Complete) CLL 3001 HELIOS™Phase 3 BR ± ibrutinib (In progress) PCYC-1117 RESONATE™ 17Phase 2 ibrutinib in del(17p) (Enrollment Complete) PCYC-1108 Phase 1b ibrutinib with FCR or BR (Closed) ibrutinib 420 mg PO until disease progression (n=27) 85 Patients Treated Abbreviations: BR; bendamustine/rituximab; FCR, fludarabine/cyclophosphamide/rituximab. R/R CLL 1. Byrd JC, et al. N Engl J Med. 2013 [Epub 19 June 2013]. 2. Brown J, et al. EHA 2012, Abstract 1590. 3. Jaglowski SM, et al. ASCO 2012, Abstract 6508. *Enrollment to the FCR cohort was suspended due to poor enrollment as patients were required to be fludarabine naïve. At a median 8.1 months follow-up, ibrutinib + BR ORR 93% with 13% CRs and low rate of disease progression. No added toxicity observed when adding ibrutinib to BR. 2 PCYC-1109Phase 1b/2 ibrutinib with ofatumumab (closed) For group 1 (n=27), rapid response onset with 100% ORR for 24 CLL/SLL patients , 67% for 3 Richter’s patients; favorable safety profile; and durable remissions have been observed3 Group 1: ibrutinib 420 mg PO until disease progression + ofatumumab weekly x 8; then every 4 weeks x 4 (starting at week 5) Group 2: ibrutinib 420 mg PO until disease progression + ofatumumab weekly x 8; then every 4 weeks x 4 Group 3: ofatumumab weekly x 8; then every 4 weeks x 4 + ibrutinib 420 mg PO until disease progression ibrutinib 840 mg PO until disease progres