Knight Therapeutics Announces Filling of Supplement to a New Drug Submission for NERLYNX® (neratinib) to Treat HER2-Positive...
September 03 2020 - 5:15PM
Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a pan-American
(ex-US) specialty pharmaceutical company, announced filing of the
Supplement to a New Drug Submission (SNDS) of NERLYNX for
HER2-Positive Metastatic Breast Cancer in Canada.
NERLYNX was originally approved by Health Canada in
July 2019 for the extended adjuvant treatment of women with early
stage hormone receptor positive, HER2-overexpressed/amplified
breast cancer within one year after completion of trastuzumab-based
adjuvant therapy.1
The SNDS is supported by the results of the Phase
III NALA trial, a randomized controlled trial of neratinib plus
capecitabine versus Tykerb® (lapatinib) plus capecitabine in
HER2-positive metastatic breast cancer patients previously treated
with ≥ 2 HER2-directed regimens.
“We’re excited to submit a new indication of
NERLYNX to Health Canada, enabling us to offer a new targeted
treatment option for Canadian women and physicians,” said Samira
Sakhia, President and Chief Operating Officer at Knight
Therapeutics.
Knight and Puma Biotechnology, Inc. (NASDAQ: PBYI)
signed a licensing agreement in January 2019 granting Knight the
exclusive right to commercialize NERLYNX® (neratinib) in Canada.
Under the terms of the License Agreement, Knight will be
responsible for all commercial activities and future regulatory
submissions for NERLYNX® in Canada.
About HER2-Positive Breast
Cancer
Up to 20% of patients with breast cancer tumors
over-express the HER2 protein (HER2-positive disease).
HER2-positive breast cancer is often more aggressive than other
types of breast cancer, increasing the risk of disease progression
and death2. About 6.6%-8% of HER2-positive breast cancer is
metastatic disease based on a Canadian population study3. The
median overall survival for metastatic HER2-positive patients is
28.1 months from a contemporary population-based study4.
About NALA
The NALA trial is a randomized controlled Phase III
trial of neratinib plus capecitabine versus Tykerb® (lapatinib)
plus capecitabine in HER2-positive metastatic breast cancer
patients with ≥ 2 previous HER2-directed therapies . 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). Treatment with neratinib in combination with
capecitabine resulted in a statistically significant improvement in
PFS (Hazard Ratio 0.76; 95% CI: 0.63, 0.93; p=0.0059) compared to
treatment with lapatinib plus capecitabine.
The most common adverse reactions of any grade
(>5%) in the neratinib plus capecitabine arm were 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. The most frequently reported Grade 3 or 4 adverse reactions
were diarrhea, nausea, vomiting, fatigue and decreased
appetite.
The recommended neratinib dose for advanced or
metastatic breast cancer is 240 mg (6 tablets) given orally once
daily with food on days 1-21 of a 21-day cycle plus capecitabine
(750 mg/m2 given orally twice daily) on days 1-14 of a 21-day cycle
until disease progression or unacceptable toxicities5.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in
Montreal, Canada, is a pan-American (ex-US) specialty
pharmaceutical company focused on developing, acquiring or
in-licensing and commercializing innovative pharmaceutical products
for Canada and Latin America. Knight owns a controlling stake in
Grupo Biotoscana, a pan-Latin American specialty pharmaceutical
company. Knight Therapeutics Inc.'s shares trade on TSX under the
symbol GUD. For more information about Knight Therapeutics Inc.,
please visit the company's web site at www.gud-knight.com or
www.sedar.com.
Forward-Looking Statement
This document contains forward-looking statements
for Knight Therapeutics Inc. and its subsidiaries. These
forward-looking statements, by their nature, necessarily involve
risks and uncertainties that could cause actual results to differ
materially from those contemplated by the forward-looking
statements. Knight Therapeutics Inc. considers the assumptions on
which these forward-looking statements are based to be reasonable
at the time they were prepared but cautions the reader that these
assumptions regarding future events, many of which are beyond the
control of Knight Therapeutics Inc. and its subsidiaries, may
ultimately prove to be incorrect. Factors and risks, which could
cause actual results to differ materially from current expectations
are discussed in Knight Therapeutics Inc.'s Annual Report and in
Knight Therapeutics Inc.'s Annual Information Form for the year
ended December 31, 2019 as filed on www.sedar.com. Knight
Therapeutics Inc. disclaims any intention or obligation to update
or revise any forward-looking statements whether as a result of new
information or future events, except as required by law.
For further information, please contact:
Knight Therapeutics Inc.Samira SakhiaPresident and
Chief Operating OfficerT: 514-678-8930F: 514-481-4116Email:
info@gudknight.comWebsite: www.gud-knight.com
Knight Therapeutics Inc.Arvind UtchanahChief
Financial OfficerT. 514.484.4483 ext. 115F. 514.481.4116Email:
info@gudknight.comWebsite: www.gud-knight.com
References
- NERLYNX® Product Monograph, September 17, 2019
- Slamon DJ, et, al. Science 1987; 235:177–182.
- Elizabeth Hammonda, et al. Cancer Epidemiology 45 (2016)
82–90.
- Benjamin Daniels, et al. Breast Cancer Research and Treatment.
https://doi.org/10.1007/s10549-018-4804-0
- Cristina Saura, et al. J Clin Oncol 38. DOI:
10.1200/JCO.20.00147
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