PHARMACYCLICS, INC.
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(Exact name of registrant as specified in its charter)
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Delaware
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000-26658
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94-3148201
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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995 E. Arques Avenue, Sunnyvale, California
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94085-4521
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(Address of principal executive offices)
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(Zip Code)
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(Former name or former address, if changed since last report.)
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Item 7.01
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Regulation FD Disclosure.
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·
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The trial results of the first Phase III study (RESONATE, PCYC-1112-CA), a head-to-head comparison of IMBRUVICA® (ibrutinib) versus ofatumumab in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL);
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That IMBRUVICA® (ibrutinib) will be featured in an oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology (“ASCO”) highlighting long-term responses to treatment, with up to three years of follow up in 132 patients with treatment naive or relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL); and
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That IMBRUVICA® (ibrutinib) in combination with the anti-CD20 antibody, ofatumumab, showed a Kaplan Meier estimate of continued clinical response at 18 months of 82.5% in heavily pre-treated patients with chronic lymphoma leukemia (CLL), small lymphocytic leukemia (SLL), prolymphocytic leukemia (PLL) and Richters Transformation (RT) and that the results from this study would be presented at ASCO .
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“Independent Evaluation of Ibrutinib Efficacy 3 Years Post-Initiation of Monotherapy in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia Including Deletion 17p Disease”; and
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“Randomized Comparison of Ibrutinib Versus Ofatumumab in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Results From the Phase III RESONATETM Trial”
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Item 9.01
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Financial Statements and Exhibits.
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Exhibit No.
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Description
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99.1
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Press Release dated May 31, 2014 entitled, “IMBRUVICA® (ibrutinib) Significantly Improves Progression Free Survival, Overall Survival and Overall Response as compared to Ofatumumab in Patients with Previously Treated CLL/SLL in its First Phase III study”
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99.2
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Press Release dated May 31, 2014 entitled, “IMBRUVICA® (ibrutinib) Shows Durable, Long-Term Responses for Patients with CLL”
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99.3
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Press Release dated May 31, 2014 entitled, “IMBRUVICA® (ibrutinib) Combination with anti CD20 Antibody Shows Compelling Results in Heavily Pretreated Patients with CLL and Related Diseases”
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99.4
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Oral presentation entitled “Independent Evaluation of Ibrutinib Efficacy 3 Years Post-Initiation of Monotherapy in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia Including Deletion 17p Disease”
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99.5
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Oral presentation entitled “Randomized Comparison of Ibrutinib Versus Ofatumumab in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Results From the Phase III RESONATETM Trial”
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PHARMACYCLICS, INC.
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By:
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/s/ Manmeet S. Soni
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Name: Manmeet S. Soni
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Title: Chief Financial Officer
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Exhibit No.
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Description
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99.1
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Press Release dated May 31, 2014 entitled, “IMBRUVICA® (ibrutinib) Significantly Improves Progression Free Survival, Overall Survival and Overall Response as compared to Ofatumumab in Patients with Previously Treated CLL/SLL in its First Phase III study”
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99.2
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Press Release dated May 31, 2014 entitled, “IMBRUVICA® (ibrutinib) Shows Durable, Long-Term Responses for Patients with CLL”
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99.3
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Press Release dated May 31, 2014 entitled, “IMBRUVICA® (ibrutinib) Combination with anti CD20 Antibody Shows Compelling Results in Heavily Pretreated Patients with CLL and Related Diseases”
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99.4
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Oral presentation entitled “Independent Evaluation of Ibrutinib Efficacy 3 Years Post-Initiation of Monotherapy in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia Including Deletion 17p Disease”
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99.5
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Oral presentation entitled “Randomized Comparison of Ibrutinib Versus Ofatumumab in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Results From the Phase III RESONATETM Trial”
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