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Pharmacyclics Highlights Important New Data For IMBRUVICAA® (ibrutinib) In B-Cell Malignancies

SUNNYVALE, Calif., May 14, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced IMBRUVICA®  (ibrutinib) will be featured in ten abstracts, including both company-sponsored research studies and investigator-sponsored studies. Preliminary data from these abstracts about IMBRUVICA is available as of today on the website of the American Society of Clinical Oncology (ASCO). Updated results will be presented at the 50 th Annual Meeting of ASCO being held May 30 through June 3, 2014, in Chicago, IL.

The abstracts presented at ASCO include an oral presentation of long term ibrutinib follow up of 3 years, showing how single agent IMBRUVICA achieved durable responses in patients with treatment naive (TN) or relapsed/refractory (R/R) CLL/SLL including those with deletion 17p, as independently confirmed. The ASCO presentations also include longer term follow up of IMBRUVICA's use in combination with an antibody targeting CD20, ofatumumab. This study shows how the combination is well tolerated and highly active (83% ORR) in patients with previously treated R/R CLL/SLL in all dosing sequences investigated.

"Presentations at ASCO showcase IMBRUVICA's long-term efficacy and safety profile as a single agent, even in high-risk patients, as well as high response rates with long-term durability when IMBRUVICA is administered in combination with an antibody targeting CD20," said Bob Duggan, CEO and Chairman of the Board, Pharmacyclics.

Oral Presentations The "Randomized comparison of ibrutinib versus ofatumumab in relapsed or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the phase III RESONATE trial" (Abstract #LBA7008) data have been accepted for presentation at the meeting and are embargoed until May 31, 2014 at 6:30 a.m. CT.  

Title: Independent evaluation of ibrutinib efficacy 3 years post-initiation of monotherapy in patients with chronic lymphocytic leukemia/small lymphocytic leukemia including deletion 17p disease (Abstract #7014) Session: Leukemia, Myelodysplasia, and Transplantation Oral Abstract Session Date : Tuesday, June 3, 2014 Presentation Time: 11:33 a.m. Location: McCormick Place, Room E354A Presenter: Susan O'Brien, M.D., The University of Texas MD Anderson Cancer Center, TX, USADr. O'Brien will present independent assessment of efficacy data 3 years after the initiation of therapy with single agent IMBRUVICA to confirm and further characterize the durability of response. The presented results show that single-agent IMBRUVICA showed durable responses in patients with treatment naive (TN) or relapsed/refractory (R/R) CLL/SLL including those with del17p, as independently confirmed with 3 years of follow-up.

Preliminary results: Of 132 CLL/SLL (31 TN, 101 R/R) patients evaluated, the median age was 68 years, 36 (27.3%) patients (2 TN, 34 R/R) had del17p and 36 (27.3%) had del11q.  R/R patients including 34 with del17p had a median of 4 (range, 1–12) prior therapies. The updated ORR (by independent review) was 78.0% for all-treated patients (83.9% TN-, 76.2% R/R and 55.9% for those R/R with del17p). Additionally, 5 R/R patients, 2 with del (17p), had a best response of PR with lymphocytosis. Median DOR was not reached for all-treated patients, and was 25.0 months (range, 4.8–34.3) in patients with del17p. Median time on study was 29.4 months (range, 0.7–38.1) for all-treated patients, and 27.3 months (range, 0.9–37.5) for R/R patients with del17p. Patients receiving prior therapy experienced serious or greater than or equal to Grade 3 adverse events that decreased after 1 year on treatment. No new safety signals were observed in long-term follow-up; 64% of patients remain on treatment with ibrutinib. Conclusions: Single-agent ibrutinib showed durable responses in patients with TN or R/R CLL/SLL including those with del17p, as independently confirmed with 3 years of follow-up. Further data and analysis will be presented during the oral presentation at ASCO June 3, 2014.

Selected Poster Presentation

Title: A phase 1b/2 study evaluating activity and tolerability of the BTK inhibitor ibrutinib in combination with ofatumumab in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and related diseases (Abstract #7009) Session: Leukemia, Myelodysplasia, and Transplantation Poster Highlights Session Date: Saturday, May 31, 2014 Presentation Time: 1:15 p.m. Location: McCormick Place, Room S405, Poster #1 Presenter: Samantha Jaglowski, M.D., M.P.H., The Ohio State University Comprehensive Cancer Center, Columbus, OH, USADr. Jaglowski will present efficacy data from three cohorts of patients receiving IMBRUVICA and ofatumumab, an anti-CD20 antibody, in three different administration sequences.

Preliminary results: A total of 71 patients (27, 20, 24 in G1, 2, 3) were enrolled and treated with IMBRUVICA daily and ofatumumab in 28-day cycles until progressive disease. Median age was 64 years; 61% had Rai stage III/IV; 65 patients had CLL, 1 SLL, 2 Prolymphocytic leukemia (PLL) and 3 Richter's Transformation (RT); 75% had lymph nodes greater than or equal to 5 cm; 44% had del17p; 31% had del11q.Group 1 (G1) received one cycle of IMBRUVICA monotherapy, followed by ofatumumab. Group 2 (G2) received ofatumumab on Day 1 of Cycle 1, and IMBRUVICA on Day 2 of Cycle 1. Group 3 (G3) received two cycles of ofatumumab monotherapy, and IMBRUVICA on Day 1 of Cycle 3.  Most common grade 3-4 adverse events (AE) was neutropenia in 17%; 39% had serious adverse events (SAEs) ; 45% had infusion related reactions (IRR) (with greater than or equal to g 3 in 1 pt in G2); 6 patients had AEs leading to ibrutinib discontinuation; 9 patients died within 30 days of last dose and 2 within f/u period.  Overall response rate per investigator in CLL/SLL was 100% in G1, 79% in G2, and 71% in G3. G3 had 4 patients who progressed before taking ibr. At study end, 52/58 responders (90%) were progression-free with f/u of 16, 12 and 11 months for G1, 2 and 3, respectively. Two patients achieved a partial response with lymphocytosis. Three RT patients had disease control followed by progressive disease (PD) on Day 471, 168, and 137.  At 12 months, PFS was 89%, 85%, and 90% in G1, 2 and 3, respectively; 76% continued on IMBRUVICA in a long-term extension study; 2 patients had a transplant.  Conclusions: IMBRUVICA combined with ofatumumab is well tolerated and highly active (83% ORR) in patients with pre-treated R/R CLL/SLL in all 3 dosing sequences investigated. Because of these compelling results, randomized trials evaluating anti-CD20 antibody in combination with IMBRUVICA with a PFS endpoint are ongoing. Further data and analysis will be presented during the data presentation at ASCO May 31, 2014.

Other Company Sponsored Presentations

Trial in Progress Title: A phase 3 study of ibrutinib in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously treated follicular lymphoma or marginal zone lymphoma. (Abstract TPS8611^) Session: Lymphoma and Plasma Cell Disorders General poster session Date: Monday, June 2, 2014 Presentation Time: 1:15 p.m. Location: S Hall A2 Presenter: Nathan Fowler, M.D., The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Trial in Progress Title: A randomized, double-blind, placebo-controlled phase 3 study of ibrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with newly diagnosed nongerminal center B-cell subtype of diffuse large B-cell lymphoma (DLBCL). (Abstract TPS8615^) Session: Lymphoma and Plasma Cell Disorders General poster session Date: Monday, June 2, 2014 Presentation Time: 1:15 p.m. Location: S Hall A2. Presenter: Anas Younes, M.D., Memorial Sloan Kettering Cancer Center, New York, NY, USA

INDICATIONS IMBRUVICA is indicated for the treatment of:

  • Patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • Patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

These indications are based on overall response rate. An improvement in survival or disease-related symptoms has not been established.

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