BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical
company developing innovative molecularly targeted and
immuno-oncology drugs for the treatment of cancer, today presented
initial clinical data from an ongoing Phase 1 trial of the Bruton’s
Tyrosine Kinase (BTK) inhibitor BGB-3111 combined with the
anti-CD20 antibody obinutuzumab in patients with chronic
lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) and
follicular lymphoma (FL) at the 14th International Conference on
Malignant Lymphoma (14-ICML) in Lugano, Switzerland. The initial
Phase 1 data demonstrate that the combination is well tolerated
with an overall response rate (ORR) of 89% including complete
responses (CRs) in 22% of treatment naïve (TN) CLL/SLL patients, an
ORR of 92% with CRs in 16% of relapsed/refractory (R/R) CLL/SLL
patients, and an ORR of 73% with CRs in 33% of R/R FL patients.
“This clinical trial is supported by preclinical work suggesting
that BGB-3111 may combine well with antibodies that rely on
antibody-dependent cell-mediated cytotoxicity, such as
obinutuzumab, because of less off-target inhibition of
interleukin-2-inducible T-cell kinase. The preliminary clinical
results to date suggest that the combination is well tolerated and
highly active in patients with CLL or SLL and FL. Complete
responses have already been observed in patients with both disease
types, including CLL or SLL patients with high-risk features,
despite a very short follow-up time,” commented Constantine Tam,
MD, Disease Group Lead for Low Grade Lymphoma and Chronic
Lymphocytic Leukemia at Peter MacCallum Cancer Centre, Director of
Haematology at St. Vincent’s Hospital, Australia, and lead author
of the presentation.
“We are very pleased to report initial results from our first
combination trial with BGB-3111. The preliminary complete response
rate in CLL and SLL, as well as the frequency and depth of
responses in FL, appear to be favorable compared to reported data
with BTK inhibitors or anti-CD20 antibodies alone. Given the depth
and durability of BGB-3111 monotherapy activity in our trials to
date, we look forward to seeing the combination data mature over
time and plan to initiate late-stage trials of this combination in
FL,” commented Jane Huang, MD, Chief Medical Officer, Hematology at
BeiGene.
On the basis of data presented on BGB-3111, BeiGene announced
that it plans to expand its global registrational program for
BGB-3111 to include a Phase 2 pivotal trial of BGB-3111 in
combination with obinutuzumab compared to obinutuzumab alone in
patients with R/R FL. In addition, based on data with BGB-3111
monotherapy presented earlier at this meeting, BeiGene is planning
to initiate a Phase III trial comparing BGB-3111 with bendamustine
plus rituximab in patients with TN CLL. These two additional trials
will expand the late-stage clinical trial program for BGB-3111,
which includes an ongoing global Phase 3 comparison trial with
ibrutinib in Waldenström’s macroglobulinemia (WM) and single-arm
pivotal trials in R/R CLL/SLL and R/R mantle cell lymphoma intended
to support approval of BGB-3111 in China.
Summary of Results from the Ongoing Phase 1
Trial
The multi-center, open-label Phase 1 trial of BGB-3111 with
obinutuzumab in patients with B-cell malignancies is being
conducted in Australia and the United States and consists of a
dose-escalation phase and a dose-expansion phase in
disease-specific cohorts, which include TN or R/R CLL/SLL and R/R
FL. The dose-escalation component is testing BGB-3111 at 320 mg
once daily (QD) or 160 mg twice daily (BID) in 28-day cycles, in
combination with obinutuzumab; obinutuzumab was administered in
line with standard CLL dosing (three loading doses of 1000 mg
weekly followed by 1000 mg on day one of cycles 2–6). The ongoing
dose-expansion component is testing doses of BGB-3111 at 160 mg BID
with the same obinutuzumab schedule. As of March 31, 2017, 45
patients with CLL/SLL and 17 patients with FL were enrolled in the
trial.
At the time of the data cutoff of March 31, 2017, BGB-3111 was
shown to be well tolerated in both CLL/SLL and FL. The most
frequent adverse events (AEs) (≥15%) of any attribution in CLL/SLL
were petechiae/purpura/contusion (33%), neutropenia (31%),
thrombocytopenia (22%), fatigue (18%), pyrexia (18%), upper
respiratory tract infection (18%), and diarrhea (16%); all of these
were grade 1 or 2 except for grade 3 or 4 neutropenia (20%) and
grade 3 or 4 thrombocytopenia (4%). The most frequent AEs (≥15%) in
FL were petechiae/purpura/contusion (35%), fatigue (29%), cough
(18%), diarrhea (18%), dizziness (18%), headache (18%), insomnia
(18%), nausea (18%), and upper respiratory tract infection (18%);
all of these were grade 1 or 2. Serious AEs occurred in 24% of both
the CLL/SLL and FL patients. Infusion-related reactions occurred in
24% of CLL/SLL patients and 6% of FL patients; all cases were grade
1 or 2 except for one grade 4 case in a CLL/SLL patient. There were
no cases of serious hemorrhage (≥ grade 3 hemorrhage or central
nervous system hemorrhage of any grade) or atrial fibrillation.
Only one patient discontinued treatment due to an AE, squamous cell
carcinoma (SCC), and this patient had a prior history of SCC.
At the time of the data cutoff, 43 patients with CLL/SLL (18 TN,
25 R/R) and 15 patients with R/R FL had greater than 12 weeks of
follow-up and were evaluable for efficacy. In TN CLL/SLL, after a
median follow-up of 7.0 months (2.8–11.8 months), the overall
response rate (ORR) was 89% with complete responses (CRs) in 22%
and partial responses (PRs) in 67% of patients. Stable disease (SD)
was observed in 11% of patients. In R/R CLL/SLL, at a median
follow-up time of 8.0 months (3.8–14.0 months) the ORR was 92% with
CRs in 16% and PRs in 76% of patients. SD was observed in 4% of
patients. In R/R FL, at a median follow-up time of 6.2 months
(1.2–10.7 months), the ORR was 73% with CRs in 33% and PRs in 40%
of patients. Stable disease was observed in 13% of patients. One
patient with R/R CLL/SLL had progressive disease (Richter’s
transformation), and two patients with R/R FL had progressive
disease.
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, both as monotherapy and in
combination with other agents. 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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