Follow-up Results of Phase 2 Study of Investigational Agent,
Ibrutinib, Suggest High and Durable Responses in
Relapsed/Refractory Mantle Cell Lymphoma
ATLANTA, Dec. 11, 2012 /PRNewswire/ -- Pharmacyclics, Inc.
(NASDAQ: PCYC) today announced follow-up findings from an ongoing,
open-label, Phase 2, single-agent study suggesting that in patients
with relapsed or refractory mantle cell lymphoma (MCL), both those
who were bortezomib-naive and bortezomib-exposed, the
investigational oral agent ibrutinib (PCI-32765) resulted in high
and durable responses and was generally well tolerated. In the
study, 111 patients received ibrutinib and 110 were evaluable for
efficacy. The median follow-up time was 9.2 months, with a range of
time to response to treatment of 1.4 to 16.4 months.
The results were presented by lead investigator Michael L. Wang, M.D., associate professor in
the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, at
the 54th Annual Meeting of the American Society of
Hematology (ASH) in Atlanta,
Ga. The study showed an overall response rate (ORR) of 68
percent, including a complete response (CR) of 22 percent and a
partial response (PR) of 46 percent with a median progression free
survival (PFS) estimated at 13.9 months. Results were similar
between the bortezomib-naive and bortezomib-exposed patients.
Long-term follow up of the initial 51 patients enrolled in this
study that were presented last year at ASH shows there was an
incremental improvement in the response rate over time. The ORR
increased for this patient subset from 69 percent in 2011 to an ORR
of 75 percent in 2012, with the CR increasing from 16 percent to 39
percent over the same period.
"Now with a larger number of patients studied, we see the
overall response rate remains durable and the safety profile
continues to appear manageable," said Dr. Wang. "In addition, what
is particularly encouraging is that with longer follow-up there is
an incremental increase in the number of patients who achieve
complete response."
Relapsed MCL means the disease has returned after an initial
partial or total remission. Refractory MCL refers to cancer that
does not respond to current treatment.
Safety data were available for 111 patients in the trial.
Patients treated with ibrutinib experienced treatment-emergent
adverse events (AEs) that were consistent with previously reported
data. Treatment-emergent AEs were mainly grade 1 or 2.
Treatment-emergent AEs of all grades occurring in 20 percent or
more patients were diarrhea, fatigue, nausea, upper respiratory
tract infection and dyspnea (shortness of breath). Pneumonia was
the only grade 3 or higher treatment-emergent AE occurring in 5
percent or more patients.
"These results are encouraging because they suggest ibrutinib
provided a durable response in the treatment of mantle cell
lymphoma in this Phase 2 study," said Bob
Duggan, CEO and Chairman of the Board of Directors of
Pharmacyclics. "Pharmacyclics' overall mission is to improve the
quality and duration of life for oncology patients."
Study Details
PCYC-1104-CA is an international, multicenter, open-label, Phase
2, single-agent study that treated 111 relapsed or refractory
patients (63 bortezomib-naive and 48 bortezomib-exposed) with oral
ibrutinib 560 mg daily for continuous dosing until disease
progression. The primary endpoint of the study is ORR. Duration of
response and safety evaluation are important secondary
endpoints.
About Mantle Cell Lymphoma
MCL is an aggressive type of B-cell non-Hodgkin lymphoma (NHL)
that usually occurs in middle-aged or older adults. The disease
typically begins in the lymph nodes but can spread to other
tissues, such as bone marrow and liver. In the United States, there are approximately
70,130 new cases of NHL and 4,600 new cases of MCL each year.
About Ibrutinib
Ibrutinib was designed to specifically target and selectively
inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a
key mediator of at least three critical B-cell pro-survival
mechanisms occurring in parallel – regulating B-cell apoptosis,
cell adhesion, and lymphocyte migration and homing. Data are
consistent with a mechanistic model whereby ibrutinib blocks BCR
signaling, which drives cells into apoptosis and/or disrupts cell
migration and adherence to tumor-protective microenvironments.
The effectiveness of ibrutinib alone or in combination with
other treatments is being studied in several B-cell malignancies,
including chronic lymphocytic leukemia/small lymphocytic lymphoma,
relapsed/refractory mantle cell lymphoma, diffuse large B-cell
lymphoma, follicular lymphoma and multiple myeloma. A comprehensive
late-stage Phase 2 and 3 program is under way.
Conference Call and Webcast Details
Pharmacyclics will be holding a conference call on Wednesday, December 12, 2012 at 8:30 AM ET. To participate in the conference
call, please dial 1-877-407-0778 for domestic callers and
1-201-689-8565 for international callers. To access the live audio
broadcast or the subsequent archived recording, log on to
http://ir.pharmacyclics.com/events.cfm. The archived version of the
webcast will be available for 30 days on the Investor Relations
section of the company's website at www.pharmacyclics.com.
About the Pharmacyclics and Janssen Collaboration
Pharmacyclics, Inc. and Janssen Biotech, Inc. entered into
a worldwide collaboration on December 8,
2011, to develop and commercialize ibrutinib. Following
regulatory approval, Pharmacyclics and Janssen will
co-commercialize ibrutinib. Each company will lead development for
specific indications as stipulated in a global development
plan.
About Pharmacyclics
Pharmacyclics® is a clinical-stage biopharmaceutical
company focused on developing and commercializing innovative
small-molecule drugs for the treatment of cancer and immune
mediated diseases. Our mission and goal is to build a viable
biopharmaceutical company that designs, develops and commercializes
novel therapies intended to improve quality of life, increase
duration of life and resolve serious unmet medial healthcare needs;
and to identify promising product candidates based on scientific
development and administrational expertise, develop our products in
a rapid, cost-efficient manner and pursue commercialization and/or
development partners when and where appropriate.
Presently, Pharmacyclics has three product candidates in
clinical development and several preclinical molecules in lead
optimization. We are committed to high standards of ethics,
scientific rigor, and operational efficiency as we move each of
these programs to viable commercialization.
The Company is headquartered in Sunnyvale, California and is listed on NASDAQ
under the symbol PCYC. To learn more about how Pharmacyclics
advances science to improve human healthcare visit us at
http://www.pharmacyclics.com.
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Note: Data in this release correspond to ASH Abstract
904.
SOURCE Pharmacyclics, Inc.