MONTREAL, July 16, 2019 — Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, announced today that Health Canada has approved NERLYNX® (neratinib) 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 therapy1. Knight has the exclusive right to commercialize NERLYNX® in Canada under a license agreement with Puma Biotechnology, Inc. (NASDAQ: PBYI) (“Puma”).
“The news every woman wants when she has finished her breast cancer treatment is that her cancer is in remission, that she is now cancer free. The approval of NERLYNX® in Canada is even better news.” comments Durhane Wong-Rieger, President & CEO of Canadian Organization for Rare Disorders. “Every woman we interviewed who had received NERLYNX® said she was willing to do almost anything to improve the chances, however slight, that her cancer would not return or would not metastasize.”
According to Canadian Cancer Statistics, breast cancer is the third most commonly diagnosed cancer, accounting for 13% of all cancers.2 It is also the most commonly diagnosed cancer among women.2 Approximately 26,300 women were diagnosed with breast cancer in 2017, and 5,000 died of the disease in the same year.2 A Canadian population-based study estimates that approximately 15 percent of patients with breast cancer have HER 2-positive tumors.3
“The approval of NERLYNX® is a significant treatment advance for patients with early breast cancer,” said Jonathan Ross Goodman, Chief Executive Officer of Knight. “After the initial treatment, NERLYNX® further reduces the likelihood of the cancer coming back, giving women the possibility to live cancer free.”
“The approval of NERLYNX® by Health Canada is a major achievement in helping physicians improve treatment outcomes for their breast cancer patients and we look forward to supporting our partner, Knight Therapeutics, in bringing this novel therapy to the Canadian market,” said Puma President and CEO, Alan Auerbach.
NERLYNX® is a kinase inhibitor that works by interfering with the growth of certain tumor cells. The approval is based on the safety and efficacy of a multicenter, randomized, double-blind, placebo-controlled study in women with early-stage HER2-positive breast cancer, who had previously received trastuzumab-based adjuvant therapy. A total of 2,840 patients with early-stage, HER2-positive breast cancer who completed treatment with trastuzumab within the previous two years were evaluated for the amount of time after the start of the trial that it took for the cancer to come back or for death to occur from any cause (invasive disease-free survival). The primary analysis demonstrated that NERLYNX® significantly reduced the risk of invasive disease recurrence or death at 24 months by 34% (HR=0.66 with 95% CI: 0.49, 0.90, two-sided p = 0.008) when compared to placebo in the ITT population. In an exploratory subgroup analysis for patients who were hormone receptor-positive and less than one year from completion of trastuzumab-based adjuvant therapy, the hazard ratio for invasive disease-free survival was 0.49 (95%CI: 0.30, 0.78). The estimated 2-year event free rate was 95.3% for NERLYNX® arm and 90.8% for placebo arm for a difference of 4.5%. Patients treated with NERLYNX® experienced higher incidences of treatment-emergent adverse events (99% vs 88%), grade 3-4 adverse events (50% vs 13%), and treatment-related adverse events (96% vs 57%) than those treated with placebo. In the NERLYNX® arm, the most common adverse reactions (=10%) were diarrhea (95%), nausea (43%), abdominal pain (36%), fatigue (27%), vomiting (26%), rash (18%), stomatitis (14%), decreased appetite (12%), muscle spasms (11%), and dyspepsia (10%).1
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. 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.gudknight.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, 2018. 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.
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- NERLYNX™ (neratinib) tablets. Product Monograph, July 2019.
- Canadian Cancer Statistics, 2017. Toronto, ON: Canadian Cancer Society; 2017. Available at: cancer.ca/Canadian-Cancer-Statistics-2017-EN.
- E. Hammond et al. Cancer Epidemiology 45 (2016) 82-90.