Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, announced top line results from the Phase III NALA trial
of the Company's lead drug candidate PB272 (neratinib) in patients
with HER2-positive metastatic breast cancer who have failed two or
more prior lines of HER2-directed treatments (third-line disease)
in the setting of metastatic disease. The Phase III NALA trial is a
randomized controlled trial of neratinib plus capecitabine versus
Tykerb® (lapatinib) plus capecitabine in patients with third-line
HER2-positive metastatic breast cancer. The trial enrolled 621
patients who were randomized (1:1) to receive either neratinib plus
capecitabine or lapatinib plus capecitabine. The trial was
conducted globally at sites in North America, Europe, Asia-Pacific
and South America. The co-primary endpoints of the trial are
centrally confirmed progression free survival (PFS) and overall
survival (OS). An alpha level of 1% was allocated to the PFS and 4%
allocated to OS. The study was to be considered positive if either
of the co-primary endpoints was positive. Puma reached agreement
with the U.S. Food and Drug Administration (FDA) under a Special
Protocol Assessment (SPA) for the design of the Phase III clinical
trial and the European Medicines Agency (EMA) also provided
follow-on scientific advice (SA) consistent with that of the FDA
regarding the Company's Phase III trial design and endpoints used
in the trial.
For the primary analysis of centrally confirmed PFS, treatment
with neratinib plus capecitabine resulted in a statistically
significant improvement in centrally confirmed PFS (p=0.0059)
compared to treatment with lapatinib plus capecitabine. For the
primary analyses of OS, neratinib plus capecitabine resulted in an
improvement in OS that did not achieve statistical significance but
trended positively in favor of the neratinib plus capecitabine arm
of the study (p=0.21). For the secondary endpoint of time to
intervention for symptomatic central nervous system disease (also
referred to as brain metastases), the results of the trial showed
that treatment with neratinib plus capecitabine led to an
improvement over the combination of lapatinib plus capecitabine
(p=0.043).
The safety profile of neratinib in the Phase III NALA study was
consistent with previous clinical trials of neratinib.
Full results of the trial will be submitted to health
authorities around the world, including the U.S. Food and Drug
Administration and European Medicines Agency. Results of the trial
will be submitted for presentation at a major medical conference in
2019.
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, "We are highly encouraged by these results
from the NALA trial with the combination of neratinib plus
capecitabine in patients with HER2-positive metastatic breast
cancer who have failed two or more prior lines of HER2-directed
treatments. We look forward to working with the regulatory
authorities in the hope of bringing another potential treatment
option to patients with HER2-positive metastatic breast cancer as
soon as possible."
Conference Call
Puma Biotechnology will host a conference call at 1:30 p.m.
PST/4:30 p.m. EST on Monday, December 17, 2018, to discuss the
results of its NALA trial. The call may be accessed by dialing
1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please
dial in at least ten minutes in advance and inform the operator
that you would like to join the “Puma Biotechnology Conference
Call.” A live webcast of the conference call may be accessed on the
Investors section of the Puma Biotechnology website at
http://www.pumabiotechnology.com. A replay of the call will be
available approximately one hour after completion of the call and
will be archived on Puma’s website for 30 days.
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.
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 inpatients 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.
To help ensure patients have access to NERLYNX, Puma has
implemented the Puma Patient Lynx support program to assist
patients and health care 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.
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.
Further information about Puma Biotechnology can be found at
www.pumabiotechnology.com.
Important EU NERLYNX® (neratinib) Safety
Information
All suspected adverse reactions should be reported in
accordance with the national reporting system.
The adverse reactions described in this section were identified
in the randomized Phase 3 clinical trial (n=2840). The most common
adverse reactions of any grade were diarrhoea (93.6%), nausea
(42.5%), fatigue (27.3%), vomiting (26.8%), abdominal pain (22.7%),
rash (15.4%), decreased appetite (13.7%), abdominal pain upper
(13.2%), stomatitis (11.2%), and muscle spasms (10.0%).
The most common Grade 3-4 adverse reactions were diarrhoea
(Grade 3, 36.9% and Grade 4, 0.2%) and vomiting (Grade 3, 3.4% and
Grade 4, 0.1%).
Adverse reactions reported as serious included diarrhoea (1.9%),
vomiting (1.3%), dehydration (1.1%), nausea (0.5%), alanine
aminotransferase increased (0.4%), aspartate aminotransferase
increased (0.4%), abdominal pain (0.3%), fatigue (0.3%) and
decreased appetite (0.2%).
For full European prescribing information, please refer to
the NERLYNX (neratinib) Summary of Product Characteristics on the
European Medicines Agency website
(http://www.ema.europa.eu/ema/).
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the submission of results of the
NALA trial to regulatory authorities and timing for presentation of
the full results of the NALA trial. 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 Puma’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. 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/20181217005783/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1-424-248-6500info@pumabiotechnology.comir@pumabiotechnology.com
David Schull or Alex Fudukidis, Russo Partners,
+1-212-845-4200david.schull@russopartnersllc.comalex.fudukidis@russopartnersllc.com
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