Data published online in Clinical Breast
Cancer
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced that efficacy results of neratinib in
HER2-positive, hormone receptor-positive (HR+), early stage breast
cancer (eBC) from the Phase III ExteNET trial were published in
Clinical Breast Cancer. The manuscript appears in the October 5,
2020 online issue accessible at
https://www.clinical-breast-cancer.com/article/S1526-8209(20)30258-5/fulltext.
ExteNET was a multicenter, randomized, double-blind, Phase III
trial of 2,840 HER2-positive eBC patients who received neratinib
after neoadjuvant and/or adjuvant therapy with chemotherapy and
trastuzumab. Patients were stratified by hormone receptor status
and randomly assigned to one year of treatment with either oral
neratinib 240 mg/day or placebo. The primary endpoint of the trial
was invasive disease-free survival (iDFS) with overall survival as
a key secondary endpoint. Within the European Union, neratinib is
approved in patients with HR+ breast cancer who initiated treatment
within one year of completing an adjuvant trastuzumab containing
regimen.
The manuscript presents data focusing on HR+ patients who
initiated treatment within a year of completing an adjuvant
trastuzumab containing treatment (HR+ /< 1 yr) and subgroups of
clinical interest including patients who did not achieve a
pathological complete response (no pCR) after neoadjuvant treatment
and therefore were at a high risk of disease recurrence. (HR+/
<1 yr, no pCR)
In the HR+ /< 1 yr patient population, the absolute 5-year
invasive disease-free survival benefit versus placebo was 5.1%
(HR=0.58, 95% CI 0.41‒0.82) and absolute 8-year overall survival
benefit was 2.1%. (HR=0.79, 95% CI 0.55‒1.13). The 5-year
cumulative incidence of CNS metastases was 0.7% in the neratinib
arm and 2.1% in the placebo arm.
In the HR+/ <1 yr, no pCR subgroup of patients that were at a
high risk of disease recurrence the absolute 5-year iDFS benefit in
the neratinib arm versus placebo was 7.4% (HR=0.60; 95% CI
0.33‒1.07) and the 8-year overall survival benefit was 9.1%
(HR=0.47; 95% CI 0.23–0.92).
Most common grade 3 adverse events were diarrhea (39% vs
placebo, 1%; without mandatory anti-diarrheal prophylaxis),
vomiting (4% vs <1%), and fatigue (2% vs <1%).
Professor Arlene Chan, Vice Chair Breast Cancer Research Centre
– WA, said, “Deciding on which patients benefit most from a given
therapy is an important goal for clinicians. This newly published
study provides consistent and durable benefits of neratinib in a
subset of HER2-positive early stage breast cancer patients who are
considered to be at greater risk of relapse: namely patients with
HR+ tumors that did not achieve a pCR after neoadjuvant treatment
(no pCR). The benefits demonstrated are meaningful in all endpoints
evaluated, including iDFS, OS and CNS recurrence, and thus should
help guide future clinical decisions.”
Hope S. Rugo, MD, Professor of Medicine, University of
California San Francisco Comprehensive Cancer Center, said,
“HER2-positive HR+ patients who do not achieve a pCR are at
increased risk of recurrence, even after receiving current standard
of care treatment. In a descriptive subset analysis, extended
adjuvant therapy with neratinib demonstrated a positive benefit in
these patients not only in iDFS, but also in OS. In addition, the
trend toward lower CNS involvement is a very important
consideration, given the profound impact of CNS metastasis on
future prognosis. These data coupled with the recently published
data from the CONTROL study, which shows improved tolerability with
dose escalation, should allow more patients to benefit from this
important therapy.”
Alan H. Auerbach, Chief Executive Officer and President of Puma,
added, “Although there have been many new treatment options for
patients with early stage HER2-positive breast cancer, the risk of
disease recurrence remains significant and more must be done. These
newly published data demonstrate that neratinib provides a
clinically meaningful reduction in the risk of recurrence and
provides a very important option for these high risk patients.”
About HER2-Positive Breast Cancer
Up to 20% of patients with breast cancer tumors over-express the
HER2 protein (HER2-positive disease) and in the ExteNET study, 57%
of patients were found to have tumors that were hormone-receptor
positive. HER2-positive 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
recurring, up to 25% of patients treated with trastuzumab
experience recurrence within 10 years, the majority of which are
metastatic recurrences.
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 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. In February 2020, NERLYNX was also
approved by the FDA in combination with capecitabine for the
treatment of adult patients with advanced or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2-based regimens in the metastatic setting. NERLYNX was
granted marketing authorization by the European Commission in 2018
for the extended adjuvant treatment of adult patients with early
stage hormone receptor-positive HER2-overexpressed/amplified breast
cancer and who are less than one year from completion of prior
adjuvant trastuzumab-based therapy. NERLYNX is a registered
trademark of Puma Biotechnology, Inc.
Further information about Puma Biotechnology may be found at
www.pumabiotechnology.com.
IMPORTANT SAFETY INFORMATION
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated:
- As a single agent, for the extended adjuvant treatment of adult
patients with early-stage HER2-positive breast cancer, to follow
adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult
patients with advanced or metastatic HER2-positive breast cancer,
who have received two or more prior anti-HER2 based regimens in the
metastatic setting.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage diarrhea. If diarrhea
occurs despite recommended prophylaxis, treat 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 (reported in ≥ 5% of patients)
were as follows:
- NERLYNX as a single agent: Diarrhea, nausea, abdominal pain,
fatigue, vomiting, rash, stomatitis, decreased appetite, muscle
spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin,
abdominal distention, epistaxis, weight decreased, and urinary
tract infection.
- NERLYNX in combination with capecitabine: Diarrhea, nausea,
vomiting, decreased appetite, constipation, fatigue/asthenia,
weight decreased, dizziness, back pain, arthralgia, urinary tract
infection, upper respiratory tract infection, abdominal distention,
renal impairment, and muscle spasms.
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 CYP3A4 inhibitors: Avoid concomitant use.
- Moderate CYP3A4 and P-glycoprotein (P-gp) dual 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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201005005904/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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