BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical
company developing innovative molecularly targeted and
immuno-oncology drugs for the treatment of cancer, today presented
updated data from an ongoing Phase 1 study of Bruton’s tyrosine
kinase (BTK) inhibitor BGB-3111 in patients with Waldenström’s
macroglobulinemia (WM) at the 14th International Conference on
Malignant Lymphoma (14-ICML) in Lugano, Switzerland. The updated
Phase 1 data continue to demonstrate that BGB-3111 is well
tolerated, with a very good partial response (VGPR) rate of 43% and
with an overall response rate (ORR) of 90% in 42 efficacy-evaluable
patients with a median follow-up time of 12.3 months.
“The updated data continue to suggest that BGB-3111 is well
tolerated in WM. Particularly notable is the VGPR rate of over 40%
in an evaluable population of 42 patients. In addition, responses
to BGB-3111 appear to deepen with time and to occur in patients
both with and without MYD88 mutations. The rates of adverse
event-related discontinuation and disease progression remain very
low,” commented Judith Trotman, MBChB, FRACP, FRCPA, Director of
Clinical Research in Haematology at the Concord Repatriation
General Hospital, Clinical Associate Professor of Medicine at the
University of Sydney, and the lead author of the abstract.
“We are very pleased to update our Phase 1 data of BGB-3111 in
patients with WM. The high rate of VGPRs observed to date may
result in part from BGB-3111’s ability to completely and
sustainably occupy BTK in both circulating and nodal lymphocytes.
The VGPR rate also further supports the continued evaluation of
BGB-3111 in its global, head-to-head Phase 3 study against
ibrutinib in WM,” commented Jane Huang, MD, Chief Medical Officer,
Hematology at BeiGene.
Summary of Results from the Ongoing Phase 1
Study
The multi-center, open-label Phase 1 trial of BGB-3111 as
monotherapy in B-cell malignancies is being conducted in Australia,
New Zealand, South Korea, and the United States and consists of a
dose-escalation phase and a dose-expansion phase in
disease-specific cohorts, which include treatment naïve and
relapsed/refractory WM. The ongoing dose-expansion phase is testing
doses of 160 mg twice a day (BID) or 320 mg once a day (QD). As of
March 31, 2017, 48 patients with WM were enrolled in the study.
Responses were determined according to the modified Sixth
International Workshop on WM (IWWM) criteria.
BGB-3111 was shown to be well tolerated with no discontinuation
for BGB-3111-related toxicity to date. Adverse events (AEs) were
generally mild in severity and self-limited. The most frequent AEs
(>10%) of any attribution among 48 patients evaluable for safety
were petechiae/purpura/contusion (35%), upper respiratory tract
infection (31%), constipation (25%), diarrhea (19%), epistaxis
(19%), nausea (17%), cough (15%), anemia (15%), headache (15%),
neutropenia (13%), and rash (13%), all of which were grade 1 or 2
in severity except for grade 3 or 4 anemia and neutropenia (8%
each) as well as grade 3 or 4 diarrhea and headache (2% each). Five
serious AEs were assessed to be possibly related to BGB-3111; these
included one case each of hemothorax, atrial fibrillation, colitis,
febrile neutropenia, and headache. Among AEs of special interest,
there were a total of three cases of atrial fibrillation (all grade
1 or 2), and one case of serious hemorrhage (hemothorax), defined
as grade 3 or higher hemorrhage or central nervous system
hemorrhage of any grade. Three events led to treatment
discontinuation: one case each of bronchiectasis, prostate
adenocarcinoma, and adenocarcinoma of pylorus.
At the time of the data cutoff, 42 patients were evaluable for
response. Patients not evaluable for efficacy included two patients
with less than 12 weeks of follow-up, three patients with IgM <
500mg/dl at baseline, and one patient with inaccurate baseline IgM
due to cryoprotein. At a median follow-up of 12.3 months (4.4–30.5
months), the ORR was 90% (38/42 patients) and the major response
rate was 76% (32/42 patients), with VGPRs in 43% (18/42) of
patients and partial responses in 33% (14/42) of patients. There
were two cases of disease progression.
Investor Call and Webcast Information
BeiGene will host an investor call and webcast to discuss the
data presented at 14-ICML and its development program.
Date & Time: Friday, June 16,
2017, 2:00 PM CEST (8:00 AM EDT, 8:00 PM China
Standard Time)
Dial-in Numbers: 1-845-675-0437 or
1-866-519-4004 (US), 400-620-8038 or 800-819-0121 (China), +852
30186771 (Hong Kong), or +65 67135090 (International)
Conference ID
Number: 33044427
A live webcast and replay 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 1-646-254-3697 (US), 400-632-2162 (China), +852 30512780
(Hong Kong), or +61 2 8199 0299 (International).
About BGB-3111
BGB-3111 is a potent and highly selective investigational small
molecule inhibitor of BTK (Bruton’s Tyrosine Kinase). BGB-3111 has
demonstrated higher selectivity against BTK than ibrutinib (the
only BTK inhibitor currently approved by the U.S. Food and Drug
Administration and the European Medicines Agency) based on
biochemical assays, higher exposure than ibrutinib based on their
respective Phase 1 experience, and sustained 24-hour BTK occupancy
in both the blood and the lymph node.
About BeiGene
BeiGene is a global, clinical-stage, research-based
biotechnology company focused on molecularly targeted and
immuno-oncology cancer therapeutics. With a team of over 400
employees in China, the United States, and Australia, BeiGene is
advancing a pipeline consisting of novel oral small molecules and
monoclonal antibodies for the treatment of cancer. BeiGene is
working to create combination solutions aimed at having both a
meaningful and lasting impact on cancer patients.
Forward-Looking Statements
This 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 of BGB-3111 and our future
development plans for BGB-3111. 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; actions of regulatory agencies,
which may affect the initiation, timing and progress of clinical
trials; BeiGene's ability to achieve market acceptance in the
medical community necessary for commercial success; BeiGene's
ability to obtain and maintain protection of intellectual property
for its technology and drugs; BeiGene's reliance on third parties
to conduct preclinical studies and clinical trials and
manufacturing; 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/Media Contact
Lucy Li, Ph.D.
+1 781-801-1800
ir@beigene.com
media@beigene.com
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