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 clinical data from an ongoing Phase 1 study of BTK
inhibitor BGB-3111 in patients with chronic lymphocytic leukemia
(CLL) and small lymphocytic lymphoma (SLL) in a poster 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 and highly active in CLL/SLL, with a
high overall response rate (94%) and a very low treatment
discontinuation rate (3%) at a median follow-up of 10.5 months for
efficacy evaluation.
“The updated data demonstrate that BGB-3111 has a high overall
response rate in CLL and SLL, independent of poor-risk molecular
features. It is also well tolerated, with only a single instance of
toxicity-related discontinuation to date. Late-stage trials will
further characterize BGB-3111’s clinical benefit and safety in CLL
and SLL,” commented John Seymour, MBBS, FRACP, PhD, Director of
Cancer Medicine at Peter MacCallum Cancer Centre in Victoria,
Australia, and the lead author of the presentation.
“The Phase 1 data on BGB-3111 in CLL and SLL have matured
favorably since our last presentation at the 2016 American Society
for Hematology Annual Meeting in December 2016. The rate and
durability of response suggest that the complete and sustained BTK
inhibition achieved with BGB-3111 results in high activity in CLL
and SLL patients in the study to date. These results further affirm
our plans to develop this agent for CLL and SLL both in China,
where we have an ongoing pivotal trial, and globally,” 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 in
patients with 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 (TN) and
relapsed/refractory (R/R) CLL/SLL. The ongoing dose-expansion
component is testing doses of 160 mg twice a day (BID) or 320 mg
once a day (QD). As of March 31, 2017, 69 patients with CLL or SLL
(18 TN, 51 R/R) were enrolled in the study.
BGB-3111 was shown to be well tolerated in CLL/SLL. The most
frequent adverse events (AEs) (≥10%) of any attribution were
petechiae/purpura/contusion (46%), fatigue (29%), upper respiratory
tract infection (28%), cough (23%), diarrhea (22%), headache (19%),
hematuria (15%), nausea (13%), rash (13%), arthralgia (12%), muscle
spasms (12%), and urinary tract infection (12%); all of these
events were grade 1 or 2 except for one case of grade 3 purpura
(subcutaneous hemorrhage), which was the only major bleeding event.
Additional adverse events of interest included one case of each
grade 2 diarrhea and grade 2 atrial fibrillation. A total of 18
serious AEs (SAEs) occurred in 13 patients, with no SAE occurring
in more than one patient. Only one patient discontinued treatment
due to an AE, a grade 2 pleural effusion.
At the time of the data cutoff, 66 patients (16 TN and 50 R/R)
had more than 12 weeks of follow-up and were evaluable for
efficacy, and three other patients had less than 12 weeks of
follow-up. After a median follow-up of 10.5 months (2.2-26.8
months), the overall response rate (ORR) was 94% (62/66) with
complete responses (CRs) in 3% (2/66), partial responses (PRs) in
82% (54/66), and PRs with lymphocytosis (PR-Ls) in 9% (6/66) of
patients. Stable disease (SD) was observed in 5% (3/66) of
patients. The patient with pleural effusion discontinued treatment
prior to week 12 and was not evaluable for response. There was one
instance of Hodgkin’s transformation. In TN CLL/SLL, at a median
follow-up time of 7.6 months (3.7-11.6 months), the ORR was 100%
(16/16) with CRs in 6% (1/16), PRs in 81% (13/16) and PR-Ls in 13%
(2/16) of patients. In R/R CLL/SLL, at a median follow-up time of
14.0 months (2.2-26.8 months), the ORR was 92% (46/50) with CRs in
2% (1/50), PRs in 82% (41/50), and PR-Ls in 8% (4/50) of patients.
Stable disease was observed in 6% (3/50) patients.
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 I 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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