Knight Therapeutics announced filing of the supplement to a new drug submission of NERLYNX for HER2-positive metastatic breast cancer in Canada.
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.
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.
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:
- 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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