BeiGene Announces Preliminary Results from the Phase 1 Clinical Trial of Zanubrutinib in Chinese Patients with B-Cell Lymphom...
22 September 2018 - 10:30AM
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage
biopharmaceutical company focused on developing and commercializing
innovative molecularly-targeted and immuno-oncology drugs for the
treatment of cancer, today presented preliminary results from the
Phase 1 trial of its investigational BTK inhibitor zanubrutinib in
Chinese patients with B-cell lymphoma in an oral presentation at
the 21st Annual Meeting of the Chinese Society of Clinical Oncology
(CSCO) in Xiamen, China.
“We continue to be encouraged by clinical data on zanubrutinib,
including these results, which we believe support its broad global
clinical development. Our recent new drug application filing for
zanubrutinib in China for patients with relapsed/refractory mantle
cell lymphoma (MCL), a type of B-cell lymphoma, is currently under
review by the National Medical Products Administration of China,
and we are hopeful that it will give patients in China, and across
the world, a new treatment option where it is so greatly needed,”
said Jane Huang, M.D., Chief Medical Officer, Hematology, at
BeiGene.
Summary of Preliminary Results from the Phase 1 Trial of
Zanubrutinib in Chinese Patients with B-Cell Lymphoma
An ongoing Phase 1 trial of zanubrutinib as a monotherapy in
patients with different subtypes of B-cell malignancies, including
Waldenström macroglobulinemia (WM), chronic lymphocytic leukemia
(CLL)/small lymphocytic lymphoma (SLL) and other non-Hodgkin’s
lymphomas (NHL), is being conducted in China. The trial is fully
enrolled and comprised of two parts – a dose escalation phase
involving 21 patients and a dose-expansion phase of 23 patients
treated with zanubrutinib at the recommended Phase 2 dose of 160 mg
taken orally twice daily.
Preliminary findings suggested that there was no significant
difference in the pharmacokinetic profile of zanubrutinib between
Chinese and non-Chinese patients. Preliminary findings also showed
complete or greater than 80 percent sustained BTK occupancy was
achieved among these patients with both single- and multiple-dose
administrations.
As of June 15, 2018, after a median follow-up of 9.5 months (2.3
months--23.4 months), 21 patients (47%) remained on treatment. With
44 patients enrolled in the trial, 34 were evaluable for response.
Of the nine patients with CLL/SLL, the overall response rate (ORR)
was 100 percent, with two complete responses (CRs), six partial
responses (PRs), and a PR with lymphocytosis (PR-L). Of the two
patients with mantle cell lymphoma (MCL), there was one CR and one
stable disease (SD). Of the two patients with WM, there was one PR
and one SD. Of the 26 patients with follicular lymphoma (FL), the
ORR was 42 percent with two CRs and nine PRs. There were three
patients with FL who were not evaluable at the time of the data
cutoff. Of the five patients with marginal zone lymphoma (MZL),
there were three SDs and two patients who were not evaluable.
At the time of data cutoff, no dose-limiting toxicities occurred
during dose escalation portion of the trial and there were no
unexpected safety signals identified in the trial. No deaths
related to adverse events were observed in the trial. The most
common adverse events (occurring in ≥ 20% of patients) of any
attribution among all 44 patients were neutrophil count decreased
(50%), anemia (32%), upper respiratory tract infection (25%), white
blood cell count decreased (25%), platelet count decreased (23%),
rash (23%), hematuria (20%), and hyperuricemia (20%).
“These preliminary safety, tolerability and pharmacokinetics
data of zanubrutinib support its ongoing clinical study. In this
study, the preliminary results suggest zanubrutinib has a high rate
of activity and is generally well-tolerated, which we believe is
based on its potency and high-degree of selectivity,” said Jun Zhu,
M.D., Medical Department Chief at the Beijing Cancer Hospital and
study presenter.
About B-Cell LymphomasLymphoma is a diverse
group of malignancies that originates from B, T or NK
cells. The most common type of B-cell lymphomas are
non-Hodgkin's lymphoma, of which diffuse large B-cell lymphoma
(DLBCL) is the most common. Other types of B-cell non-Hodgkin's
lymphoma include FL, CLL/SLL, MCL, MZL, and WM.
About ZanubrutinibZanubrutinib (BGB-3111) is an
investigational small molecule inhibitor of Bruton’s tyrosine
kinase (BTK) that is currently being evaluated in a broad pivotal
clinical program globally and in China as a monotherapy and in
combination with other therapies to treat various B-cell
malignancies.
About BeiGeneBeiGene is a global,
commercial-stage, research-based biotechnology company focused on
molecularly-targeted and immuno-oncology cancer therapeutics. With
a team of over 1,300 employees in China, the United States,
Australia and Switzerland, BeiGene is advancing a pipeline
consisting of novel oral small molecules and monoclonal antibodies
for cancer. BeiGene is also working to create combination solutions
aimed to have both a meaningful and lasting impact on cancer
patients. BeiGene markets ABRAXANE® (nanoparticle albumin–bound
paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in
China under a license from Celgene Corporation.1
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and other federal
securities laws, including statements regarding the encouraging
clinical data for zanubrutinib and BeiGene’s advancement of, and
anticipated clinical development and regulatory milestones and
plans related to zanubrutinib. Actual results may differ
materially from those indicated in the forward-looking statements
as a result of various important factors, including BeiGene's
ability to demonstrate the efficacy and safety of its drug
candidates; the clinical results for its drug candidates, which may
not support further development or marketing approval; actions of
regulatory agencies, which may affect the initiation, timing and
progress of clinical trials and marketing approval; BeiGene's
ability to achieve commercial success for its marketed products and
drug candidates, if approved; BeiGene's ability to obtain and
maintain protection of intellectual property for its technology and
drugs; BeiGene's reliance on third parties to conduct drug
development, manufacturing and other services; BeiGene’s limited
operating history and BeiGene's ability to obtain additional
funding for operations and to complete the development and
commercialization of its drug candidates, as well as those risks
more fully discussed in the section entitled “Risk Factors” in
BeiGene’s most recent quarterly report on Form 10-Q, as well as
discussions of potential risks, uncertainties, and other important
factors in BeiGene's subsequent filings with the U.S. Securities
and Exchange Commission. All information in this press
release is as of the date of this press release, and BeiGene
undertakes no duty to update such information unless required by
law.
Investor
Contact |
Media
Contact |
Craig West |
Liza Heapes |
+1 857-302-5189 |
+ 1 857-302-5663 |
ir@beigene.com |
media@beigene.com |
1 ABRAXANE®, REVLIMID® and VIDAZA® are registered trademarks of
Celgene Corporation.
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