Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, announced that results from an ongoing Phase II clinical
trial of Puma's drug neratinib are being presented at the 2019 San
Antonio Breast Cancer Symposium (SABCS) that is currently taking
place in San Antonio, Texas. The presentation entitled, “Neratinib
+ trastuzumab + fulvestrant for HER2-mutant, hormone
receptor-positive, metastatic breast cancer: updated results from
the phase 2 SUMMIT ‘basket’ trial,” are being presented at a poster
Session by Hans Wildiers, M.D., Ph.D., University Hospitals Leuven,
Belgium, an investigator of the trial. A copy of this poster
presentation is available on the Puma website
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20191211005896/en/
SUMMIT Trial Poster, 12/11/19 at SABCS
2019
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 by the European Commission for the extended
adjuvant treatment of hormone receptor-positive HER2-positive early
stage breast cancer in August 2018.
The Phase II SUMMIT basket trial is an open-label, multicenter,
multinational study to evaluate the safety and efficacy of
neratinib administered daily to patients who have solid tumors with
activating HER2 or HER3 mutations. In the HER2-mutant, HR-positive
breast cancer cohort, 28 patients received 240 mg of neratinib
daily in combination with trastuzumab and fulvestrant. In this
cohort, patients had received a median of 4 prior lines of therapy
in the metastatic setting (range 0-10 prior regimens) before
entering the trial. All patients had been previously treated with
an endocrine agent prior to entering the study, including 17
patients (61%) who had received prior fulvestrant. Further, 15
patients (54%) received prior cyclin-dependent kinase 4/6 (CDK4/6)
-inhibitor therapy. Twenty-one patients (75%) had received prior
chemotherapy.
The interim efficacy summary of the breast cohort that received
neratinib in combination with trastuzumab and fulvestrant showed
that for the 17 efficacy evaluable patients, 9 patients (53%)
experienced a confirmed objective response, all of which were
classified as partial responses, and 10 patients (59%) experienced
clinical benefit (clinical benefit is defined as confirmed complete
response or partial response or stable disease for at least 24
weeks). The median duration of response has not been reached and
the median progression-free survival was 9.8 months. At the time of
data cut-off, five patients continued to receive treatment.
The safety profile observed in patients treated with the
combination of neratinib plus trastuzumab plus fulvestrant in the
SUMMIT study was consistent with that observed previously in
metastatic patients with HER2 amplified tumors. All patients
received anti-diarrheal prophylaxis with loperamide alone. The
interim safety results of the study showed that the most frequently
observed adverse event was diarrhea. For the 28 safety evaluable
patients enrolled in this cohort, 10 patients (36%) reported grade
3 diarrhea. The median duration of grade 3 diarrhea for those
patients was 5.5 days. No patient permanently discontinued
neratinib due to diarrhea.
Prof. Dr. Hans Wildiers said, “The combination of neratinib plus
trastuzumab plus fulvestrant therapy demonstrates encouraging
clinical activity with durable responses in this heavily pretreated
metastatic breast cancer patient population with activating HER2
mutations and hormone receptor-positive disease. We look forward to
continuing to enroll this cohort of SUMMIT.”
Alan H. Auerbach, CEO and President of Puma Biotechnology,
added, “We are very pleased with the activity seen with neratinib
in combination with trastuzumab and fulvestrant in this cohort of
patients with HER2-mutated breast cancer. We are in the process of
expanding this HR-positive breast cancer cohort in SUMMIT with the
intent of using this data to support future registration. We look
forward to enrolling additional patients into this HR-positive
breast cancer cohort in order to generate the additional data
required to support approval of this combination therapy.”
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.
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 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, 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.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the development of combinations
involving neratinib. 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 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,
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191211005896/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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