BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical
company focused on developing and commercializing innovative
molecularly-targeted and immuno-oncology drugs for the treatment of
cancer, today presented results on its investigational BTK
inhibitor zanubrutinib, from two poster presentations at the 23rd
Congress of the European Hematology Association (EHA). The EHA
meeting is taking place in Stockholm, Sweden from June 14-17, 2018.
“We continue to be encouraged by the quality and durability of
response with zanubrutinib in the treatment of patients with
Waldenström macroglobulinemia (WM), particularly with the
observation that 43 percent of the evaluable patients achieved a
very good partial response (VGPR). Additionally, the safety results
from the combined experience in four ongoing monotherapy trials
demonstrate that zanubrutinib was generally well-tolerated,”
commented Jane Huang, M.D., Chief Medical Officer, Hematology, at
BeiGene. “As these results mature, and as we near completion of
enrollment in our Phase 3 trial comparing zanubrutinib with
ibrutinib in patients with WM, we are hopeful that zanubrutinib, if
approved, may represent a valuable treatment option for patients
with this disease.”
In addition to zanubrutinib data presentations, BeiGene is
providing the following updates to its planned development program
for zanubrutinib:
- BeiGene has received results from the independent review of
response data from the 86-patient single-arm pivotal Phase 2 study
of zanubrutinib in Chinese patients with relapsed or refractory
mantle cell lymphoma (MCL). The overall response rate (ORR) of 84
percent (59% complete response rate) met the pre-specified criteria
for a positive trial, and the median duration of response has not
been reached with 8.3 months median follow-up. The safety profile
was consistent with previously reported clinical data for
zanubrutinib. BeiGene plans to submit its first new drug
application (NDA) for zanubrutinib in China for the treatment of
patients with relapsed or refractory MCL later this year. Full
results of the study are planned to be presented at an upcoming
major medical conference.
- The global Phase 3 study comparing zanubrutinib to ibrutinib in
patients with WM has met its enrollment target. The trial has
closed new patient screening and is expected to complete enrollment
in July. The Company plans to submit its first NDA in the United
States for zanubrutinib in patients with WM in 2019.
Zanubrutinib in WM from Phase 1 Trial (EHA
#PS1186)
A Phase 1 trial of zanubrutinib as a monotherapy in patients
with different subtypes of B-cell malignancies, including WM, is
being conducted in Australia, New Zealand, the United States,
Italy, and South Korea. As of November 3, 2017, 67 patients with WM
have been enrolled in the trial and were evaluable for safety.
Fifty-one patients were evaluable for efficacy, excluding those
with less than 12 weeks of follow-up (n=13) and those with IgM less
than 5 g/L at baseline (n=3). Of the 51 patients evaluable for
efficacy, 12 were treatment naïve and 39 patients were relapsed or
refractory to prior treatment. At the time of the data cutoff, 59
patients remained on study treatment. Results included:
- For the 51 patients with WM evaluable for response, the ORR was
92 percent (47/51), and major response rate was 80 percent, with 43
percent of patients achieving a VGPR (defined as a >90%
reduction in baseline IgM levels and improvement of extramedullary
disease by CT scan).
- The 12-month progression-free survival (PFS) was estimated at
91 percent. The median PFS had not yet been reached.
- Median time to response (partial response or higher) was 88
days (range, 77-279).
- The median IgM decreased from 32.5 g/L (range, 5.3-88.5) at
baseline to 4.9 g/L (range, 0.1-57).
- Of 22 patients with hemoglobin <10 g/dL at baseline, the
median increased from 8.7 g/dL (range, 6.3-9.8) to 13.8 g/dL
(range, 7.7-15.8).
- While the presence of MYD88L265P appears to be associated with
response and depth of response with zanubrutinib treatment,
significant activity was also observed in patients with MYD88WT
(ORR 83%, major response rate 50%, VGPR rate 17%).
- The most frequent adverse events (AEs) (>15%, all Grade 1-2
but one) of any attribution were petechia/purpura/contusion (37%),
upper respiratory tract infection (34%), constipation (18%) and
diarrhea (18%). Grade 3-4 AEs of any attribution reported in two or
more patients included anemia (7%), neutropenia (6%), basal cell
carcinoma (3%), hypertension (3%), squamous cell carcinoma (3%),
pyrexia (3%), pneumonia (3%), major hemorrhage (3%), and actinic
keratosis (3%).
- Serious AEs (SAEs) were seen in 22 patients (33%), with events
in five patients (7%) considered possibly related to zanubrutinib
treatment: febrile neutropenia, colitis, atrial fibrillation,
hemothorax (spontaneous), and headache.
- Atrial fibrillation/flutter was experienced by four patients
(6%), all Grade 1-2. Major hemorrhage was seen in two patients
(3%).
- Four patients (6%) discontinued due to AEs: fatal worsening
bronchiectasis, prostate cancer, gastric adenocarcinoma, and acute
myeloid leukemia.
- Two patients (3%) discontinued study treatment due to disease
progression as assessed by investigator and one patient remains on
treatment post disease progression.
“Zanubrutinib continues to demonstrate robust activity in
patients with WM. Deeper response rates have been maintained
with longer follow-up in the Phase 1 trial and we are optimistic
that zanubrutinib will demonstrate both high rates of activity and
tolerability for patients, based on its potency and high-degree of
selectivity,” said Judith Trotman, M.D., Director, Clinical
Research Unit in Haematology, Concord Hospital, and Professor at
the University of Sydney, Australia.
Pooled Analysis of Safety Data from Zanubrutinib
Monotherapy Trials (EHA #PF445)
Pooled safety data from patients with various B-cell lymphomas
in four ongoing zanubrutinib monotherapy studies, totaling 476
patients with a median exposure of seven months, will be presented
at the EHA meeting. Overall, the data suggest that exposure
levels of zanubrutinib resulting in complete and sustained BTK
inhibition can be achieved and that zanubrutinib was generally
well-tolerated. Results included:
- Events of interest with BTK inhibitor therapy, such as atrial
fibrillation/flutter (2%), major hemorrhage (2%), and Grade 3 and
above diarrhea (1%) have been infrequent.
- Treatment discontinuation due to zanubrutinib-related AEs was
uncommon (3%).
- The majority of patients (94%) experienced one or more AE of
any attribution, primarily Grades 1 or 2. The most common Grade 3
or higher AEs of any attribution were neutropenia/neutrophil count
decreased/febrile neutropenia (14%), anemia (7%) and
thrombocytopenia/platelet count decreased (7%).
- SAEs were reported in 116 patients (24%), with 38 patients (8%)
assessed by the investigator as related to zanubrutinib. The most
common SAEs were pneumonia/lung infection (6%), pleural effusion
(1%), and febrile neutropenia (1%). The only treatment-related SAE
reported in greater than one percent of patients was pneumonia/lung
infection (2%). No cases of pneumocystis jiroveci pneumonia (PJP)
or cytomegalovirus (CMV) reactivation were reported.
- The most common bleeding events observed included
petechiae/purpura/contusion (26%) and hematuria (11%). Major
hemorrhage (2%) included gastrointestinal hemorrhage/melena (n=3),
intraparenchymal CNS hemorrhage Grade 5, hematuria, purpura,
hemorrhagic cystitis, renal hematoma, and hemothorax (1 each). The
median time to first major hemorrhage was 1.2 months.
- Amongst patients with emergent atrial fibrillation/flutter
(n=8), a majority had known risk factors including hypertension
(n=2), pre-existing cardiovascular disease (n=2), and concurrent
infection (n=1).
- The cumulative rates of Grade 3 or higher infections were 14
percent at six months, 19 percent at 12 months and 21 percent at 18
months. The exposure-adjusted incidence rate was 1.82 per 100
person-months.
- The most common second primary malignancies included basal cell
carcinoma (3%) and squamous cell carcinoma of the skin (1%).
“While BTK inhibitor therapy has historically been shown to be
highly effective in the treatment of certain chronic B cell
malignancies, such as chronic lymphocytic leukemia (CLL), WM, and
MCL, specific events such as atrial fibrillation, serious diarrhea,
and CNS bleeding, as well as appreciable overall rates of
discontinuation of treatment due to tolerability or toxicity,
remain concerns. With this pooled safety analysis of zanubrutinib
monotherapy, we wanted to further assess whether its selectivity
profile would translate into tolerability. We are encouraged that
the low rates of BTK inhibitor-associated events, as well as low
rates of toxicity-related treatment discontinuation, may allow for
continuous disease control. We are hopeful that, if approved,
patients with these hematologic malignancies could potentially
lessen drug safety concerns, to focus on their lives rather than
their disease,” said Constantine Tam, M.D., Director of
Haematology, St. Vincent’s Hospital and Consultant Haematologist,
Peter MacCallum Cancer Center, in Australia.
Today’s Investor Conference Call & Webcast
Information
- Date and Time: Friday, June 15, 2018, 8:00 am
EDT (Friday, June 15, 2018, 8:00 pm China Standard Time)
- Dial-In Numbers: 1-844-461-9930 or
1-478-219-0535 (U.S.), 400-682-8609 or 800-870-0169 (China),
852-30114522 (Hong Kong), 65-66221010 (Singapore), 61-282239773
(Australia), 0856619361 (Sweden), or 1-478-219-0535
(International).
- Conference ID Number: 7756029
- Webcast and Replay: A live webcast and replay
of the event will be available on BeiGene’s investor website,
http://ir.beigene.com. The dial-in replay will be available
approximately two hours after the conference and will be available
for two days following the event. It can be accessed by dialing
1-855-859-2056 (U.S.) or 1-404-537-3406 (International), or
400-683-7185 (China).
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 lymphomas.
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 1,100 employees in China, the United States, and
Australia, 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® (azaciditine) 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 |
Lucy Li, Ph.D. |
|
Liza Heapes |
+1 781-801-1800 |
|
+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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