BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage
biotechnology company focused on developing and commercializing
innovative molecularly-targeted and immuno-oncology drugs for the
treatment of cancer, today announced that it has begun
commercializing XGEVA® (denosumab) in China for the treatment of
giant cell tumor of bone (GCTB). This marks the first Amgen product
that has been transitioned to BeiGene for commercialization in
China since the commencement of the parties’ global strategic
oncology collaboration in January 2020. Amgen gained approval from
the China National Medical Products Administration (NMPA) for XGEVA
in May 2019 for the treatment of adults and skeletally mature
adolescents (defined by at least one mature long bone and with a
body weight ≥ 45 kg) with GCTB that is unresectable or where
surgical resection is likely to result in severe morbidity. In
addition, a supplemental new drug application (sNDA) for XGEVA as a
prevention for skeletal-related events in patients with multiple
myeloma and in patients with bone metastases from solid tumors has
been accepted by the Center for Drug Evaluation (CDE) of the NMPA
in April 2020 and is currently under review.
“XGEVA provides a novel medical therapy for the treatment of
GCTB, which has predominantly been treated by surgery and other
adjuvant therapies including radiotherapy and embolization. XGEVA
has demonstrated efficacy in both inhibiting tumor growth and
dampening activity of osteoclasts, filling a void in the treatment
of the disease by enabling a multidisciplinary approach. In
clinical trials it has been shown to be well-tolerated and to help
control disease progression,” commented Xiaohui Niu, M.D., Director
of Department of Orthopedic Oncology at Beijing Jishuitan Hospital
and President of Osteosarcoma Committee of Experts of Chinese
Society of Clinical Oncology (CSCO).
The approval of XGEVA was based on clinical results from two
open-label trials (NCT00396279 and NCT 00680992) that enrolled
patients with GCTB that was either recurrent, unresectable, or for
whom planned surgery was likely to result in severe morbidity.
XGEVA achieved durable response in patients with unresectable GCTB,
with 88% five-year progression-free survival (PFS) probability. In
addition, 80% of the patients with resectable GCTB who received
XGEVA as neoadjuvant therapy experienced improvement, including 44%
who achieved surgical downstaging and 37% who avoided surgeries.1
The most common adverse reactions (≥ 10%) were generally mild or
moderate in severity and consisted of arthralgia, headache, nausea,
back pain, fatigue, and pain in extremity.
“The commencement of our commercialization of XGEVA in China
signifies an important milestone in our strategic collaboration
with Amgen. XGEVA is the first and currently only medical therapy
approved for the treatment of GCTB in China, which offers patients
a more innovative treatment option. With more than 1,200 people in
our commercial organization in China, we are excited to deliver
XGEVA and our other oncology treatments to patients who need them,”
commented Xiaobin Wu, Ph.D., General Manager of China and President
of BeiGene.
“Transitioning the commercialization of XGEVA from Amgen to
BeiGene marks another important step towards accelerating the
introduction of innovative oncology medicines to patients in China.
We look forward to jointly advancing Amgen’s oncology pipeline in
China and around the world to make a meaningful difference in the
lives of millions of cancer patients,” said My Linh Kha, Vice
President and General Manager, Amgen China. “This strategic
collaboration also enables Amgen to deepen our commitment in China
and build a more robust and complete portfolio in other chronic
disease areas such as cardiovascular disease and fragility fracture
to address the unmet needs of the aging population.”
About Giant Cell Tumor of Bone (GCTB)
GCTB is a mostly benign, but often aggressive bone
tumor afflicting younger adults between the ages of 20 to
40.2,3 It has a higher incidence rate in females, which is about
56.4%.3 Globally, GCTB accounts for approximately 4%-5% of primary
bone tumors and is comparatively more common in China than in the
U.S. and European countries.4 It is estimated that GCTB
represents 20% of primary bone tumors in China.5 Although most
GCTB tumors are benign, they often result in the complete
destruction of the affected bone, leading to bone fracture, joint
dysfunction or amputation, if not diagnosed timely and treated
properly.
Most tumors occur in the long bones of the body but can also
spread to the lungs in rare cases. Although giant cell tumors are
slow growing, patients can experience severe bone pain, swelling,
loss of mobility and pathologic fracture. Before the approval of
XGEVA®, there have been no approved therapies for GCTB. Surgery is
the main treatment option for patients with resectable GCTB;
however, some patients need to receive surgery, such as joint
resection and amputation, which is associated with significant
morbidity. Some patients will experience recurrence after the first
surgery. When tumors recur, they become more difficult to treat and
are more likely to spread to other parts of the body.
About XGEVA® (denosumab)
XGEVA (denosumab) is a fully human IgG2 monoclonal antibody
specifically binding to RANK Ligand (RANKL), a protein essential
for the formation, function and survival of osteoclasts - the cells
responsible for bone resorption. In GCTB, it has been shown
that RANKL production from stromal cells stimulates RANK receptor
on osteoclast-like giant cells, leading to dysregulated osteolysis
and tumor growth. XGEVA prevents RANKL from activating its
receptor, RANK, on the surface of osteoclasts, their precursors and
osteoclast-like giant cells.
U.S. Approved Indications
XGEVA® is indicated for the prevention of skeletal-related
events in patients with multiple myeloma and in patients with bone
metastases from solid tumors.
XGEVA® is indicated for treatment of adults and skeletally
mature adolescents with giant cell tumor of bone that is
unresectable or where surgical resection is likely to result in
severe morbidity.
XGEVA® is indicated for the treatment of hypercalcemia of
malignancy refractory to bisphosphonate therapy.
Important U.S. Safety Information
Hypocalcemia
Pre‐existing hypocalcemia must be corrected prior to initiating
therapy with XGEVA®. XGEVA® can cause severe symptomatic
hypocalcemia, and fatal cases have been reported. Monitor calcium
levels, especially in the first weeks of initiating therapy, and
administer calcium, magnesium, and vitamin D as necessary.
Concomitant use of calcimimetics and other drugs that can lower
calcium levels may worsen hypocalcemia risk and serum calcium
should be closely monitored. Advise patients to contact a
healthcare professional for symptoms of hypocalcemia.
An increased risk of hypocalcemia has been observed in clinical
trials of patients with increasing renal dysfunction, most commonly
with severe dysfunction (creatinine clearance less than 30
mL/minute and/or on dialysis), and with inadequate/no calcium
supplementation. Monitor calcium levels and calcium and vitamin D
intake.
Hypersensitivity
XGEVA® is contraindicated in patients with known clinically
significant hypersensitivity to XGEVA®, including anaphylaxis that
has been reported with use of XGEVA®. Reactions may include
hypotension, dyspnea, upper airway edema, lip swelling, rash,
pruritus, and urticaria. If an anaphylactic or other clinically
significant allergic reaction occurs, initiate appropriate therapy
and discontinue XGEVA® therapy permanently.
Drug Products with Same Active Ingredient
Patients receiving XGEVA® should not take Prolia®
(denosumab).
Osteonecrosis of the Jaw
Osteonecrosis of the jaw (ONJ) has been reported in patients
receiving XGEVA®, manifesting as jaw pain, osteomyelitis, osteitis,
bone erosion, tooth or periodontal infection, toothache, gingival
ulceration, or gingival erosion. Persistent pain or slow healing of
the mouth or jaw after dental surgery may also be manifestations of
ONJ. In clinical trials in patients with cancer, the incidence of
ONJ was higher with longer duration of exposure.
Patients with a history of tooth extraction, poor oral hygiene,
or use of a dental appliance are at a greater risk to develop ONJ.
Other risk factors for the development of ONJ include
immunosuppressive therapy, treatment with angiogenesis inhibitors,
systemic corticosteroids, diabetes, and gingival infections.
Perform an oral examination and appropriate preventive dentistry
prior to the initiation of XGEVA® and periodically during XGEVA®
therapy. Advise patients regarding oral hygiene practices. Avoid
invasive dental procedures during treatment with XGEVA®. Consider
temporarily interrupting XGEVA® therapy if an invasive dental
procedure must be performed.
Patients who are suspected of having or who develop ONJ while on
XGEVA® should receive care by a dentist or an oral surgeon. In
these patients, extensive dental surgery to treat ONJ may
exacerbate the condition.
Atypical Subtrochanteric and Diaphyseal Femoral
Fracture
Atypical femoral fracture has been reported with XGEVA®. These
fractures can occur anywhere in the femoral shaft from just below
the lesser trochanter to above the supracondylar flare and are
transverse or short oblique in orientation without evidence of
comminution.
Atypical femoral fractures most commonly occur with minimal or
no trauma to the affected area. They may be bilateral and many
patients report prodromal pain in the affected area, usually
presenting as dull, aching thigh pain, weeks to months before a
complete fracture occurs. A number of reports note that patients
were also receiving treatment with glucocorticoids (e.g.
prednisone) at the time of fracture. During XGEVA® treatment,
patients should be advised to report new or unusual thigh, hip, or
groin pain. Any patient who presents with thigh or groin pain
should be suspected of having an atypical fracture and should be
evaluated to rule out an incomplete femur fracture. Patients
presenting with an atypical femur fracture should also be assessed
for symptoms and signs of fracture in the contralateral limb.
Interruption of XGEVA® therapy should be considered, pending a
risk/benefit assessment, on an individual basis.
Hypercalcemia Following Treatment Discontinuation in
Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with
Growing Skeletons
Clinically significant hypercalcemia requiring hospitalization
and complicated by acute renal injury has been reported in
XGEVA®-treated patients with GCTB and in patients with growing
skeletons within one year of treatment discontinuation. Monitor
patients for signs and symptoms of hypercalcemia after treatment
discontinuation and treat appropriately.
Multiple Vertebral Fractures (MVF) Following Treatment
Discontinuation
Multiple vertebral fractures (MVF) have been reported following
discontinuation of treatment with denosumab. Patients at higher
risk for MVF include those with risk factors for or a history of
osteoporosis or prior fractures. When XGEVA® treatment is
discontinued, evaluate the individual patient’s risk for vertebral
fractures.
Embryo‐Fetal
Toxicity
XGEVA® can cause fetal harm when administered to a pregnant
woman. Based on findings in animals, XGEVA® is expected to result
in adverse reproductive effects.
Advise females of reproductive potential to use effective
contraception during therapy, and for at least 5 months after the
last dose of XGEVA®. Apprise the patient of the potential hazard to
a fetus if XGEVA® is used during pregnancy or if the patient
becomes pregnant while patients are exposed to XGEVA®.
Adverse Reactions
The most common adverse reactions in patients receiving XGEVA®
with bone metastasis from solid tumors were fatigue/asthenia,
hypophosphatemia, and nausea. The most common serious adverse
reaction was dyspnea. The most common adverse reactions resulting
in discontinuation were osteonecrosis and hypocalcemia.
For multiple myeloma patients receiving XGEVA®, the most common
adverse reactions were diarrhea, nausea, anemia, back pain,
thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory
tract infection, rash, and headache. The most common serious
adverse reaction was pneumonia. The most common adverse reaction
resulting in discontinuation of XGEVA® was osteonecrosis of the
jaw.
The most common adverse reactions in patients receiving XGEVA®
for giant cell tumor of bone were arthralgia, headache, nausea,
back pain, fatigue, pain in extremity, nasopharyngitis,
musculoskeletal pain, toothache, vomiting, hypophosphatemia,
constipation, diarrhea, and cough. The most frequent serious
adverse reactions were osteonecrosis of the jaw, bone giant cell
tumor, anemia, pneumonia, and back pain. The most frequent adverse
reaction resulting in discontinuation of XGEVA® was osteonecrosis
of the jaw.
The most common adverse reactions in patients receiving XGEVA®
for hypercalcemia of malignancy were nausea, dyspnea, decreased
appetite, headache, peripheral edema, vomiting, anemia,
constipation, and diarrhea.
Please visit www.XGEVA.com for full prescribing
information.
About BeiGene
BeiGene is a global, commercial-stage biotechnology company
focused on discovering, developing, manufacturing, and
commercializing innovative medicines to improve treatment outcomes
and access for patients worldwide. Our 3,800+ employees in China,
the United States, Australia, and Europe are committed to
expediting the development of a diverse pipeline of novel
therapeutics for cancer. We currently market two
internally-discovered oncology products: BTK inhibitor BRUKINSA®
(zanubrutinib) in the United States and China, and anti-PD-1
antibody tislelizumab in China. We also market or plan to market in
China additional oncology products licensed from Amgen Inc.,
Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and
EUSA Pharma. To learn more about BeiGene, please visit
www.beigene.com and follow us on Twitter at @BeiGeneUSA.
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 commercialization and potential benefits of XGEVA; and
BeiGene’s plans and expectations for the commercialization of its
and Amgen’s other oncology products and pipeline assets. 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; the
impact of the COVID-19 pandemic on the Company’s clinical
development, commercial and other operations, 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 ContactCraig West+1
857-302-5189ir@beigene.com
Media ContactLiza Heapes or Vivian Ni+1
857-302-5663 or +1 857-302-7596media@beigene.com
XGEVA® is a registered trademark of Amgen Inc.
________________
1 Thomas D, Henshaw R, Skubitz K, et al. Lancet Oncol
2010;11:275–80
2 Mendenhall WM, et al. Am J Clin Oncol. 2006;29:96-99.
3 Oncology Progress. 2005, 3(4) :316-319. DOI:
10.3969/j.issn.1672-1535.2005.04.004
4 Hoch B. Inwards C, Sundaram M, et al. Multicentric giant cell
tumor of bone. Clinicopathologic analysis of thirty cases. J Bone
Joint Surg Am, 2006, 88(9):1998-2008.
5 Szendroi M. Giant-cell tumor of bone. J Bone Surg Br, 2004,
86(1):5-12.
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