Puma Biotechnology and Strata Oncology Announce Collaboration to Accelerate Enrollment in Neratinib HER2 … – Tech Blog(press release) | Tech Blog

LOS ANGELES & ANN ARBOR, Mich.–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company,
and Strata Oncology, Inc., a precision oncology company, have entered
into a collaborative agreement to accelerate patient enrollment in
Puma’s ongoing Phase II SUMMIT trial of PB272 (neratinib). The SUMMIT
trial is a global, multi-histology, open-label, precision-medicine
‘basket’ study evaluating the safety and efficacy of neratinib in
patients with a wide variety of solid tumors with activating EGFR, HER2
or HER4 mutations.

Neratinib, an oral irreversible pan-HER kinase inhibitor, was approved
by the 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®.
Data published in the journal Nature earlier this year showed
neratinib has activity across multiple tumor types with HER2-activating
mutations.

Under the terms of the agreement, Strata will exclusively refer
HER2-mutated advanced cancer patients identified through the Strata
Trial for consideration of enrollment to Puma’s SUMMIT Trial for
neratinib.

The Strata Trial is a screening protocol providing comprehensive tumor
molecular profiling to advanced cancer patients at no cost and proactive
enrollment support for a portfolio of pharma-sponsored precision therapy
trials. Tumor profiling through the Strata Trial is provided as part of
routine care to solid tumor patients across the Strata Precision
Oncology Network, a network of 11 leading health systems representing
more than 85,000 new cancer patients annually. This large network of
trial-ready health systems with fully pre-screened advanced cancer
populations enables rapid and predictable enrollment of precision
therapy trials.

“We are pleased to partner with Puma Biotechnology to accelerate the
path to new approvals for neratinib,” said Dan Rhodes, Ph.D., CEO of
Strata Oncology. “We frequently identify HER2-mutant patients across the
Strata Precision Oncology Network and we believe this partnership will
greatly facilitate patient access to this promising clinical trial.”

“Puma’s ultimate goal is to deliver new treatment options and improve
the lives of patients with various types of cancer,” said Alshad S.
Lalani, V.P., Translational Medicine of Puma Biotechnology. “We believe
Puma’s partnership with Strata will help us reach patients with multiple
tumor types who may not otherwise know about the SUMMIT study, giving
them a chance to participate in research that’s designed to provide
important new information for future treatment.”

About Strata Oncology

Strata Oncology is a precision medicine company dedicated to
transforming cancer care by systematizing precision oncology across a
network of health systems and pharma companies. We empower health
systems to deliver a cost-effective, system-wide precision oncology
program, one that integrates cutting-edge molecular profiling and
precision therapy trials with routine care, so that all advanced cancer
patients have the opportunity to benefit. This large network of
trial-ready health systems provides a mechanism to rapidly and
predictably enroll precision therapy trials. For more information, visit www.strataoncology.com.

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 is a registered
trademark of Puma Biotechnology, Inc.

Important Safety Information (ISI)
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.

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

Forward-Looking Statements

This press release contains forward-looking statements, including
statements regarding the expected benefits from the collaboration
between Puma and Strata. All statements other than historical facts are
forward–looking statements and are based on Puma’s current expectations,
forecasts and assumptions. 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 risk and uncertainties are
identified in Puma’s filings with the Securities and Exchange
Commission, including its 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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