Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, announced that its collaborators at The Institute of
Cancer Research, London, presented results from the cohort of
patients in the plasmaMATCH trial treated with Puma's drug
neratinib at the 2019 San Antonio Breast Cancer Symposium (SABCS)
in San Antonio, Texas. The oral presentation entitled, “Results
from the plasmaMATCH trial: A multiple parallel cohort,
multi-centre clinical trial of circulating tumour DNA testing to
direct targeted therapies in patients with advanced breast cancer
(CRUK/15/010),” and the poster presentation entitled, “Results from
plasmaMATCH trial treatment Cohort B: A phase II trial of neratinib
plus fulvestrant in ER positive breast cancer or neratinib alone in
ER negative breast cancer in patients with a ERBB2 (HER2) mutation
identified via ctDNA screening (CRUK/15/010)” were presented by
Professor Nicholas Turner, M.D., Ph.D., Professor of Molecular
Oncology at The Institute of Cancer Research (ICR) and Consultant
Medical Oncologist at The Royal Marsden NHS Foundation Trust, who
is the principal investigator of the plasmaMATCH trial, and Andrew
M. Wardley, M.D., consultant medical oncologist at The Christie NHS
Foundation Trust in Manchester, England and Medical Director of the
National Institute for Health Research (NIHR) Manchester Clinical
Research Facility at The Christie, respectively. The plasmaMATCH
trial was funded by Cancer Research UK.
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plasmaMATCH Poster at SABCS 2019 (Photo:
Business Wire)
The plasma-based Molecular profiling of Advanced breast cancer
to inform Therapeutic Choices (plasmaMATCH) trial is a phase IIa,
multiple parallel cohort, open-label, multicentre trial in patients
with advanced breast cancer, which aims to assess whether analyzing
a blood sample for circulating tumor DNA (ctDNA) could provide an
alternative to biopsies for identifying the genetic mutations
present in advanced breast cancer and whether subgroups of patients
with advanced breast cancer, identified through ctDNA screening,
may benefit from a treatment targeting their type of cancer.
Approximately 1,044 patients with advanced breast cancer from
approximately 20 sites in the United Kingdom registered for the
trial and ctDNA results were available for 1,033 (98.9%) of the
patients. Depending on the results of the ctDNA screening, patients
were enrolled in one of five treatment cohorts and received therapy
to target their type of breast cancer. Patients with HER2 mutations
were enrolled in the cohort of patients who received either
neratinib monotherapy (for patients with hormone receptor negative
disease) or neratinib in combination with fulvestrant (for patients
with hormone receptor positive disease). Twenty-one patients with
HER2 mutations were enrolled in the cohort and 20 patients were
evaluable for the primary endpoint of the trial, which was
confirmed objective response rate as determined by RECIST 1.1
assessed by the investigator.
In the HER2-mutant cohort, 18 (86%) of the 21 patients had
hormone receptor positive breast cancer, 18 patients (86%) had
visceral disease, 18 patients (86%) had received prior chemotherapy
for metastatic disease, and 11 patients (52%) had received two or
more prior lines of chemotherapy for metastatic disease.
The efficacy results from the trial showed that for the 20
efficacy evaluable patients, 5 patients (25%) experienced a
confirmed objective response, and three further patients had
unconfirmed responses. The median duration of response was 5.7
months, and the median progression free survival in this cohort of
patients was 5.4 months.
Prof. Nicholas Turner, Professor of Molecular Oncology at The
Institute of Cancer Research, London, and Consultant Medical
Oncologist at The Royal Marsden NHS Foundation Trust, said,
“Somatic HER2 mutations can be readily and accurately identified
from ctDNA blood samples and are clinically actionable for targeted
therapy in metastatic breast cancers. The combination of neratinib
plus fulvestrant therapy demonstrates encouraging clinical activity
with durable responses in this heavily pretreated metastatic breast
cancer patient population with HER2-mutated disease.”
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, added, “We are very pleased with the activity seen
in this cohort of patients with HER2-mutated breast cancer with
neratinib in plasmaMATCH. This data correlates with the data
observed in the neratinib plus fulvestrant arm of the SUMMIT trial,
and we look forward to the further development of the combination
of neratinib plus trastuzumab plus fulvestrant in this patient
population.”
About The Institute of Cancer Research
The Institute of Cancer Research, London, is one of the world's
most influential cancer research organisations.
Scientists and clinicians at The Institute of Cancer Research
(ICR) are working every day to make a real impact on cancer
patients' lives. Through its unique partnership with The Royal
Marsden NHS Foundation Trust and 'bench-to-bedside' approach, the
ICR is able to create and deliver results in a way that other
institutions cannot. Together the two organisations are rated in
the top centres for cancer research and treatment globally.
The ICR has an outstanding record of achievement dating back
more than 100 years. It provided the first convincing evidence that
DNA damage is the basic cause of cancer, laying the foundation for
the now universally accepted idea that cancer is a genetic disease.
Today it is a world leader at identifying cancer-related genes and
discovering new targeted drugs for personalised cancer
treatment.
A college of the University of London, the ICR is the UK’s
top-ranked academic institution for research quality and provides
postgraduate higher education of international distinction. It has
charitable status and relies on support from partner organisations,
charities and the general public.
The ICR's mission is to make the discoveries that defeat cancer.
For more information visit http://www.icr.ac.uk.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a
focus on the development and commercialization of innovative
products to enhance cancer care. Puma in-licenses the global
development and commercialization rights to PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral
was approved by the U.S. Food and Drug Administration in July 2017
for the extended adjuvant treatment of adult patients with early
stage HER2-overexpressed/amplified breast cancer, following
adjuvant trastuzumab-based therapy, and is marketed in the United
States as NERLYNX® (neratinib) tablets. NERLYNX was granted
marketing authorization by the European Commission for the extended
adjuvant treatment of hormone receptor-positive HER2-positive early
stage breast cancer in August 2018. NERLYNX is a registered
trademark of Puma Biotechnology, Inc.
Important Safety Information Regarding NERLYNX® (neratinib)
U.S. Indication
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated for the extended adjuvant treatment of adult patients
with HER2 overexpressed/amplified breast cancer, to follow adjuvant
trastuzumab-based therapy.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage diarrhea occurring despite
recommended prophylaxis with additional antidiarrheals, fluids, and
electrolytes as clinically indicated. Withhold NERLYNX in patients
experiencing severe and/or persistent diarrhea. Permanently
discontinue NERLYNX in patients experiencing Grade 4 diarrhea or
Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
- Hepatotoxicity: Monitor liver function tests monthly for
the first 3 months of treatment, then every 3 months while on
treatment and as clinically indicated. Withhold NERLYNX in patients
experiencing Grade 3 liver abnormalities and permanently
discontinue NERLYNX in patients experiencing Grade 4 liver
abnormalities.
- Embryo-Fetal Toxicity: NERLYNX can cause fetal harm.
Advise patients of potential risk to a fetus and to use effective
contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥
5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash,
stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or
ALT increase, nail disorder, dry skin, abdominal distention, weight
decreased and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma
Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and
www.NERLYNX.com or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
DRUG INTERACTIONS:
- Gastric acid reducing agents: Avoid concomitant use with proton
pump inhibitors. When patients require gastric acid reducing
agents, use an H2-receptor antagonist or antacid. Separate NERLYNX
by at least 3 hours with antacids. Separate NERLYNX by at least 2
hours before or 10 hours after H2-receptor antagonists.
- Strong or moderate CYP3A4 inhibitors: Avoid concomitant
use.
- Strong or moderate CYP3A4 inducers: Avoid concomitant use.
- P-glycoprotein (P-gp) substrates: Monitor for adverse reactions
of narrow therapeutic agents that are P-gp substrates when used
concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety
information.
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets)
given orally once daily with food, continuously for one year.
Antidiarrheal prophylaxis should be initiated with the first dose
of NERLYNX and continued during the first 2 months (56 days) of
treatment and as needed thereafter.
To help ensure patients have access to NERLYNX, Puma has
implemented the Puma Patient Lynx support program to assist
patients and healthcare providers with reimbursement support and
referrals to resources that can help with financial assistance.
More information on the Puma Patient Lynx program can be found at
www.NERLYNX.com or 1-855-816-5421.
Further information about Puma Biotechnology may be found at
www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements. All
forward-looking statements involve risks and uncertainties that
could cause Puma’s actual results to differ materially from the
anticipated results and expectations expressed in these
forward-looking statements. These statements are based on current
expectations, forecasts and assumptions, and actual outcomes and
results could differ materially from these statements due to a
number of factors, which include, but are not limited to, the risk
factors disclosed in the periodic and current reports filed by Puma
with the Securities and Exchange Commission from time to time,
including the Company’s Annual Report on Form 10-K for the year
ended December 31, 2018. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. Puma assumes no obligation to update these
forward-looking statements, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20191212005596/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull or Maggie Beller, Russo Partners, +1-212-845-4200
david.schull@russopartnersllc.com
maggie.beller@russopartnersllc.com
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