SINGAPORE and MELBOURNE, Australia, Nov. 22, 2017 /PRNewswire/ -- A NEW breast cancer
drug shown to reduce the risk of cancer recurrence will soon be
made available in Australia,
New Zealand and throughout
South-East Asia, following a key
license deal between Specialised Therapeutics Asia (ST Asia) and US
biopharmaceutical company Puma Biotechnology, Inc. (NASDAQ:
PBYI).
Under the terms of the exclusive arrangement, Specialised
Therapeutics will market the drug NERLYNX® (neratinib)
throughout the Asia-Pacific,
beginning with Australia,
Singapore, Malaysia and Brunei.
It will be available to women with early-stage, HER2+ breast
cancer following standard of care adjuvant chemotherapy and 12
months of trastuzumab-based therapy.
Commercial terms of the agreement are not being disclosed, but
Puma will receive an upfront payment as well as milestones and
other payments on NERLYNX sales in all ST Asia regions.
NERLYNX is the first treatment to be FDA approved for
extended adjuvant therapy in early-stage HER2+ breast cancer
following adjuvant trastuzumab-based therapy.
Results from a double blind, placebo-controlled, randomised
Phase 3 study showed that NERLYNX reduces the risk of invasive
disease recurrence or death by 27% compared to placebo after a
median follow up of 5.2 years. The 5-year invasive disease-free
survival (iDFS) rate for the NERLYNX arm was 90.2% compared to
87.7% in the placebo arm (p=0.008).1
For the pre-defined subgroup of patients with hormone receptor
positive disease, approximately 57% of the overall study
population, the results of the trial demonstrated that at 5 years,
treatment with neratinib resulted in a 40% reduction of risk of
invasive disease recurrence or death versus placebo (hazard ratio =
0.60, p = 0.002 ).3 In this sub-group, the 5-year
iDFS rate for the neratinib arm was 91.2% compared to 86.8% in the
placebo arm. 1
The safety results showed the most frequently observed adverse
event for the NERLYNX-treated patients was diarrhoea, with
approximately 40% of the NERLYNX-treated patients experiencing
grade 3 or higher diarrhoea (1 patient (<1%) had grade 4
diarrhoea). Patients who received NERLYNX in this trial did not
receive any prophylaxis with anti-diarrhoeal
agents.1,2
Principal trial investigator, Professor Arlene Chan, said the availability of NERLYNX in
Australia and other regions was an
important step forward in further reducing recurrence in HER2+
early breast cancer.
"This is a drug that provides a potential cure for some women
who may otherwise have had a recurrence," she said.
"Despite the clear proven benefit of standard of care
chemotherapy and trastuzumab therapy, one in four women diagnosed
with early-stage HER2+ breast cancer can still have a relapse
within five years.
"This drug will now prevent some of those women from
experiencing that recurrence."
"My hope and expectation is that with longer follow up, not only
will recurrence rates be reduced, but they will show that the use
of NERLYNX will improve overall survival."
Specialised Therapeutics Chief Executive Officer Carlo Montagner said NERLYNX was a valuable
inclusion to the company's expanding oncology portfolio.
"We are thrilled to be able to provide this therapy to women in
our regions, working in collaboration with our new international
partner, Puma Biotechnology," he said.
"We plan to expedite access to this important medicine, with a
Special Access Program to open in Australia in Q1 2018. This will provide early
subsidised access for appropriate patients. In tandem, we will file
for TGA registration and seek regulatory approval to market in
other regions, including Singapore, Brunei, Malaysia and New
Zealand."
President and CEO of Puma Biotechnology Alan H. Auerbach said
this license agreement demonstrates the commitment to bringing
NERLYNX to patients around the world.
"We are confident this new partnership with ST Asia will ensure
all appropriate patients in the region can access this new medicine
at the earliest opportunity," he said.
NERLYNX is an oral medication taken after chemotherapy and after
12 months of treatment with a trastuzumab-based therapy, which is
the global standard of care.
About NERLYNX4
NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor
that blocks signal transduction through the epidermal growth factor
receptors, HER1, HER2 and HER4.
NERLYNX is the first HER2-targeted medication approved by the US
Food and Drug Administration (FDA) as extended adjuvant treatment
for early-stage HER2-positive (HER2+) breast cancer, for patients
who have previously been treated with the medicine trastuzumab
following surgery (i.e., adjuvant trastuzumab-based therapy).
Extended adjuvant therapy is the next step of treatment that
follows adjuvant therapy (treatment after surgery) to further
reduce the risk of breast cancer returning.
NERLYNX is an oral tablet and works by binding to multiple
receptors inside the cancer cell, blocking signals that tell cancer
cells to grow and multiply.
About HER2+ Breast Cancer
Approximately 20% to 25% of breast cancer tumours over-express
the HER2 protein. HER2+ breast cancer is often more aggressive than
other types of breast cancer, increasing the risk of disease
progression and death. Although research has shown that trastuzumab
can reduce the risk of early-stage HER2-positive breast cancer
returning after surgery, up to 24% of patients treated with
trastuzumab experience recurrence.1
About the ExteNET Study1, 2
The ExteNET trial was a double-blind, placebo-controlled, Phase
III trial of neratinib versus placebo after adjuvant treatment with
trastuzumab (Herceptin) in patients with early-stage HER2-positive
breast cancer.
The ExteNET trial randomized 2,840 patients in 41 countries with
early-stage HER2-positive breast cancer who had undergone surgery
and adjuvant treatment with trastuzumab. After completion of
adjuvant treatment with trastuzumab, patients were randomised to
receive extended adjuvant treatment with either neratinib or
placebo for a period of one year. Patients were then followed for
recurrent disease, ductal carcinoma in situ (DCIS), or death for a
period of five years after randomisation in the trial.
The primary endpoint of the trial was invasive disease free
survival (iDFS). The trial demonstrated that after a median follow
up of 5.2 years, treatment with neratinib resulted in a 27%
reduction of risk of invasive disease recurrence or death versus
placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for
the neratinib arm was 90.2% and the 5-year iDFS rate for the
placebo arm was 87.7%.
A secondary endpoint of the trial was invasive disease free
survival including ductal carcinoma in situ (iDFS-DCIS). The trial
demonstrated that treatment with neratinib resulted in a 29%
reduction of risk of disease recurrence including DCIS or death
versus placebo (hazard ratio = 0.71, p = 0.004). The 5-year
iDFS-DCIS rate for the neratinib arm was 89.7% and the 5-year
iDFS-DCIS rate for the placebo arm was 86.8%.
For the pre-defined subgroup of patients with hormone receptor
positive disease, approximately 57% of the overall study
population, the trial demonstrated that at 5 years, treatment with
neratinib resulted in a 40% reduction of risk of invasive disease
recurrence or death versus placebo. In this sub-group, the 5-year
iDFS rate for the neratinib arm was 91.2% compared to 86.8% in the
placebo arm (hazard ratio = 0.60, p = 0.002).3
The safety results showed the most frequently observed adverse
event for the neratinib-treated patients was diarrhoea, with
approximately 40% of the neratinib-treated patients experiencing
grade 3 or higher diarrhoea (1 patient (<1%) had grade 4
diarrhoea).
Puma is conducting the Phase 2 CONTROL study investigating a
structured prophylactic regimen of loperamide for the first 1-2
cycles of neratinib therapy. Emerging data suggest that loperamide
prophylaxis reduces the incidence, severity and duration of
neratinib-associated diarrhoea as compared with events observed in
ExteNET.
About Puma Biotechnology, Inc.
Puma Biotechnology, Inc. is a biopharmaceutical company with a
focus on the development and commercialisation of innovative
products to enhance cancer care. The Company in-licenses the global
development and commercialisation rights to three drug
candidates -- PB272 (neratinib (oral)), PB272 (neratinib
(intravenous)) and PB357. NERLYNX is approved for
commercial use by prescription in the
United States as extended adjuvant therapy for early stage
HER2-positive breast cancer following adjuvant trastuzumab-based
therapy and is marketed as NERLYNX.
Currently, the Company is primarily focused on the
commercialization of NERLYNX and the continued development of its
other advanced drug candidates directed at the treatment of
HER2-positive breast cancer. The Company believes that NERLYNX has
clinical application in the potential treatment of several other
cancers that over-express or have a mutation in HER2.
Further information about Puma Biotechnology can be found at
www.pumabiotechnology.com
About Specialised Therapeutics Asia
Headquartered in Singapore,
Specialised Therapeutics Asia Pte Ltd (ST Asia) is an international
biopharmaceutical company established to provide pioneering
healthcare solutions to patients throughout South East Asia, as well as in Australia and New
Zealand.
ST Asia and its regional affiliates collaborate with leading
global pharmaceutical and diagnostic companies to bring novel,
innovative and life changing healthcare solutions to patients
affected by a range of diseases. ST Asia is committed to making new
and novel therapies available to patients around the world,
targeting diseases where there remains an unmet medical need. STA's
broad therapeutic portfolio currently includes novel agents in
oncology, haematology, neurology, ophthalmology and supportive
care.
Additional information can be found at www.stabiopharma.com
Further Enquiries:
Puma
Biotechnology, Inc.
|
Specialised
Therapeutics Asia P/L
|
Alan H. Auerbach,
President and CEO
Mariann
Ohanesian
+1-424-248-6500
info@pumabiotechnology.com
ir@pumabiotechnology.com
|
Emma Power
Communications
Manager
+61-419-149-525
epower@stabiopharma.com
Singapore Office:
+65-31589940
|
References:
1.
|
Martin M et. al.
Lancet Oncol. 2017 Nov 13: S1470-2045 [Epub ahead of
print]
|
2.
|
Chan A et.al. Lancet
Oncol. 2016;17(3):367-77
|
3.
|
Martin M. et. Al.
ESMO 2017. Oral Presentation #1490.
|
4.
|
NERLYNX (neratinib)
US Product Information (approved)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf
|
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SOURCE Specialised Therapeutics Asia