ASH News Daily 2013 - Day 3 - (Page C-7)

Janssen Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Trials * MCL, CLL, DLBCL and FL (FLR2002) ENROLLING NOw and FL (FLR3001) COMING SOON A Study of Ibrutinib in Combination with Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma R MCL3002 (SHINE) N=520 KEY ELIGIBILITY CRITERIA * Patients with Newly Diagnosed MCL, 65 years and older * No prior treatment * ECOG score of 0 or 1 A N D O M I Z E Bendamustine +Rituximab +Ibrutinib 1:1 Bendamustine +Rituximab +Placebo Patients with CR/PR after initial chemoimmunotherapy will continue rituximab for 2 years For more information visit: www.clinicaltrials.gov (NCT01776840). No new sites are being opened; for any questions on the study, please contact: Dr Aleksandra Rizo at Janssen R&D at arizo@its.jnj.com A Study of Ibrutinib in Combination with Bendamustine and Rituximab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma R CLL3001 (HELIOS) N=580 KEY ELIGIBILITY CRITERIA * Active disease (at least one of the IWCLL 2008 criteria for requiring treatment) * Relapsed or refractory CLL following at least 1 prior chemotherapy-containing regimen * No presence of deletion of the short arm of chromosome 17, i.e., del (17p13.1) A N D O M I Z E Bendamustine +Rituximab +Ibrutinib 1:1 Bendamustine +Rituximab +Placebo For more information visit: www.clinicaltrials.gov (NCT01611090). No new sites are being opened; for any questions on the study, please contact: Dr. Michelle Mahler at mmahler@its.jnj.com or Dr. Angela Howes at ahowes@its.jnj.com A Study of Ibrutinib in Combination with R-CHOP in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma R DBL3001 (PHOENIx) N=800 KEY ELIGIBILITY CRITERIA * Patients, 18 years or older, with newly diagnosed, non-GCB DLBCL as determined by central IHC * Ann Arbor Stage II-IV * R-IPI score of ≥1 * ECOG 0 - 2 A N D O M I Z E R-CHOP+Ibrutinib 1:1 R-CHOP +Placebo For more information visit: www.clinicaltrials.gov (NCT01855750). No new sites are being opened; for any questions on the study, please contact: Dr. Jessica Vermeulen at JVermeul@its.jnj.com or Kevin Bellew at kbellew2@its.jnj.com An Open-label, Multicenter, Single-arm, Phase 2 Study of Ibrutinib (PCI-32765) in Subjects with refractory Follicular Lymphoma FLR2002 (DAWN) N=110 KEY ELIGIBILITY CRITERIA E N R O L L M E N T Ibrutinib * Histologic proof of Grade 1, 2, or 3a FL at initial diagnosis without clinical or pathological evidence of transformation * Prior therapy includes all of the following criteria: a. Previously treated with at least 2 prior lines of therapy, b. At least 1 prior rituximab-containing combination chemotherapy regimen c. Last prior line of therapy includes an anti CD20 monoclonal antibody-containing chemotherapy regimen * Resistant disease to the last prior therapy, defined as progression of disease during or within 12 months of the last dose of a CD20 antibody combination chemotherapy regimen For more information visit: www.clinicaltrials.gov (NCT01779791). No new sites are being opened; for any questions on the study, please contact: Dr. Jessica Vermeulen at JVermeul@its.jnj.com or Dr. Gary Gartenberg at ggartenb@its.jnj.com A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL) FLR3001 (LUSTER) N=400 KEY ELIGIBILITY CRITERIA * ≥18 years of age with histologically confirmed diagnosis of either  Follicular lymphoma Grade 1, 2, or 3a  Marginal zone lymphoma (splenic, nodal, or extra-nodal) * Relapsed or refractory disease * Received at least one prior chemoimmunotherapy regimen containing a CD20 antibody * ECOG 0-1 R A N D O M I Z E 6 Cycles BR or R-CHOP+Ibrutinib** 1:1 6 Cycles BR or R-CHOP +Placebo** **continued until disease progression or unacceptable toxicity Site selection is ongoing; for any questions on the study, please contact: Dr. Esther Rose at ERose10@its.jnj.com or Dr. Jessica Vermeulen at JVermeul@its.jnj.com *The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational uses listed will be filed with and/or approved for marketing by any regulatory agency. Janssen Research & Development, LLC PCI32765ADV-ENG01 Version 2.0, 25OCT2013 

Table of Contents for the Digital Edition of ASH News Daily 2013 - Day 3

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ASH News Daily 2013 - Day 3

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