Puma Biotechnology Presents Results of Patient Reported Outcomes in Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2018 San Antonio Breast Cancer Symposium

Marketing News – MarketingTools365 – Mktg News – Marketing Tools 365 – //// Business Marketing news and Mktg News : Puma Biotechnology Presents Results of Patient Reported Outcomes in Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2018 San Antonio Breast Cancer Symposium :

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, is
presenting updated results from a Phase II clinical trial of Puma’s drug
neratinib at the 2018 San Antonio Breast Cancer Symposium (SABCS) that
is currently taking place in San Antonio, Texas. The presentation
entitled, “The impact of neratinib with or without anti-diarrheal
prophylaxis on health-related quality of life in HER2-positive early
stage breast cancer: Analyses from the ExteNET and CONTROL trials.” is
being presented by Dr. Suzette Delaloge, Institut Gustave Roussy, Paris,
France, at a poster session on December 6 from 7:00 – 9:00 a.m. CST. A
full copy of the poster is available on the Puma Biotechnology website
at www.pumabiotechnology.com.


Neratinib was approved by the U.S. Food and Drug Administration (FDA) in
July 2017 for the extended adjuvant treatment of adult patients with
early stage HER2-positive breast cancer following adjuvant
trastuzumab-based therapy, and is marketed in the United States as
NERLYNX® (neratinib) tablets. NERLYNX was granted marketing
authorization in September 2018 by the European Commission for 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 the completion of prior adjuvant trastuzumab based
therapy

Diarrhea is the main side effect of neratinib. In ExteNET, where
antidiarrheal prophylaxis was not mandated by the study protocol, grade
1/2 diarrhea was reported in 55% and 34% of patients in the neratinib
and placebo groups, respectively, and grade 3 diarrhea occurred in 40%
and 2%, respectively. Because neratinib-induced diarrhea occurs early in
the course of treatment, a structured high dose regimen of loperamide
prophylaxis given for one or two cycles has been introduced to better
manage this side effect. The Phase II CONTROL study, conducted in the
exact same setting as ExteNET, investigated the effectiveness of
anti-diarrheal prophylaxis with loperamide alone or in combination with
budesonide or colestipol in the prevention of neratinib-associated
diarrhea.

Both ExteNET and CONTROL assessed patient-reported outcomes using the
Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B), a
validated instrument for the assessment of health-related quality of
life (HRQoL) in breast cancer. Total scores of FACT-B range from 0-144,
with higher scores indicating better HRQoL. A change of 7-8 points in
the FACT-B total score is considered clinically meaningful. Preliminary
HRQoL findings from the CONTROL study were presented in 2017 and are
posted on Puma’s website at www.pumabiotechnology.com/pr20171206.html.
The poster presented at SABCS reports more detailed and mature HRQoL
data from CONTROL, and compares it to the HRQoL findings from the
ExteNET study.

In ExteNET, 17% of patients in the neratinib group and less than 1% of
patients in the placebo group discontinued treatment because of
diarrhea. In CONTROL, 20% of patients in the loperamide cohort, 11% in
the budesonide plus loperamide cohort, and 4% in the colestipol plus
loperamide cohort discontinued treatment due to diarrhea.

The poster presentation demonstrates that in both studies decreases in
FACT-B total scores seen in early months were followed by recovery
towards baseline levels. Decreases in FACT-B total scores observed did
not cross a clinically meaningful threshold at any time point.

In the ExteNET study, a transient decrease in FACT-B total score was
observed with neratinib at month 1 (mean change from baseline, –4.6
points) followed by recovery towards baseline. Decreases were also
evident in the placebo group, with mean changes from baseline ranging
from –3.5 to –1.7 points during study treatment. After month 3, mean
changes from baseline were similar in neratinib and placebo arms. None
of these changes reached clinically meaningful thresholds (7–8 points)
at any time point.

The presentation also shows that in the CONTROL study, FACT-B total
scores decreased from baseline in all cohorts; mean changes from
baseline ranged from –6.0 to –1.5 points over the course of study
treatment. In the cohorts that had completed follow-up (loperamide,
budesonide plus loperamide), the largest decreases in FACT-B total
scores were evident during months 1 and 3 followed by recovery towards
baseline levels. None of these changes reached clinically meaningful
thresholds (7–8 points) at any time point.

An evaluation of each of the FACT-B subscales (n=5) were evaluated and
this analysis suggested that physical well-being (PWB) was the only
subscale where the clinically important difference (CID) threshold was
crossed in both trials. In the ExteNET study, in the neratinib arm,
FACT-B PWB decreased at month 1 before improving at later visits. The
mean change from baseline at month 1 with neratinib was –2.9 points and
was greater than clinically meaningful thresholds (2‒3 points); changes
at later time-points were all less than the clinically meaningful
threshold.

In the CONTROL study, decreases in FACT-B PWB were observed in all
CONTROL cohorts throughout study treatment, with largest changes from
baseline observed at month 1. In the loperamide alone and colestipol
plus loperamide cohorts, changes reached clinically meaningful
thresholds (2‒3 points) at 4 out of 5 study visits, whereas in the
budesonide plus loperamide cohort, changes crossed the CID threshold
during months 1 and 3 only.

Suzette Delaloge, MD, Institut Gustave Roussy, Paris, France, said,
“Diarrhea is the main side effect of neratinib and can be bothersome in
some patients. Although this is not a direct comparison, the
confrontation of Extenet and Control data teach us how to prevent grade
3 diarrhea and how to allow better quality of life, together with better
adherence of patients to this therapy.”

Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, “We are pleased with the HRQoL data from ExteNET
and CONTROL. We look forward to additional data from the CONTROL trial,
which may continue to improve HRQoL and adherence to treatment.”

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2
protein. 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 returning after surgery, up
to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated
for the extended adjuvant treatment of adult patients with early-stage
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, epistaxis, 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 (PPI) and H2-receptor antagonists. Separate NERLYNX by 3
    hours after antacid dosing.
  • 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.

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 three drug candidates — 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 September 2018. NERLYNX is a registered trademark of Puma
Biotechnology, Inc.

Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements, including
statements regarding the benefits of NERLYNX® and neratinib, Puma’s
clinical trials and the announcement of data relative to those trials.
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
reports filed by the Company 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, 2017. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date hereof. The Company assumes no obligation to update these
forward-looking statements, except as required by law.

Contacts

Puma Biotechnology, Inc.
Alan H. Auerbach or Mariann Ohanesian, +1
424 248 6500
info@pumabiotechnology.com
ir@pumabiotechnology.com
or
Russo
Partners
David Schull or Alex Fudukidis, +1 212 845 4200
david.schull@russopartnersllc.com
alex.fudukidis@russopartnersllc.com

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