According to Canadian Cancer Statistics, breast cancer accounts for one-quarter (25%) of all new cancer cases in women2. Approximately 27,700 women were diagnosed with breast cancer in 2020, and 5,100 died of the disease in the same year2. Studies show that up to 20% of breast cancer tumors have an over-expression of the HER2 protein. Women with breast cancer that over-expresses HER2, referred to as HER2-positive breast cancer, are at greater risk for disease progression and death than women whose tumors do not over-express HER2. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of treated patients experience recurrence within 10 years, the majority of which are metastatic recurrences4-5.
“We are pleased to provide Canadian HER2-positive breast cancer patients and physicians with an effective medicine following previous treatment with other anti-HER2 agents in the metastatic setting,” said
About NERLYNX®
NERLYNX® is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the human epidermal growth factor receptors, HER1, HER2 and HER4. On
About NALA
The efficacy of neratinib in combination with capecitabine was investigated in NALA3 (NCT01808573), a randomized, multicenter, open-label, Phase III clinical trial in 621 patients with metastatic HER2-positive breast cancer who received two or more prior anti-HER2-based regimens in the metastatic setting.
The main efficacy outcome measures were progression-free survival (PFS) and overall survival (OS). Key secondary outcome measures were objective response rate (ORR) and duration of response (DOR). Treatment with neratinib in combination with capecitabine resulted in a statistically significant improvement in PFS (
Median OS was 21 months (95% CI: 17.7, 23.5) for patients who received neratinib in combination with capecitabine compared to 18.7 months (95% CI: 15.5, 21.2) for patients who received lapatinib in combination with capecitabine (HR 0.88; 95% CI: 0.72, 1.07; p=0.2086). The ORR was 32.8% (95% CI: 27.1, 38.9) vs 26.7% (95% CI: 21.5, 32.4), respectively. Median duration of response was 8.5 months (95% CI: 5.6, 11.2) vs 5.6 months (95% CI: 4.2, 6.4), respectively. The most common adverse reactions of any grade (≥10%) in the neratinib plus capecitabine arm were diarrhea, nausea, palmar-plantar erythrodysaesthesia syndrome, vomiting, fatigue/asthenia, decreased appetite, constipation, stomatitis, weight decreased, rash, nail disorders, dizziness, back pain and arthralgia. Serious adverse reactions reported in ≥ 3 patients (1%) in the neratinib plus capecitabine arm included diarrhea, pleural effusion, vomiting, acute kidney injury, nausea, metastases to central nervous system, pneumonia, cellulitis, dehydration, seizure, constipation, pyrexia, and urinary tract infection.
The recommended neratinib dose for 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 toxicities.
About Knight Therapeutics Inc.
Forward-Looking Statements for
This document contains forward-looking statements for
Investor Contact: | |
Arvind Utchanah | |
President & Chief Operating Officer | Chief Financial Officer |
T: 514.484.4483 | T. 514.484.4483 |
F: 514.481.4116 | F. 514.481.4116 |
Email: info@knighttx.com | Email: info@knighttx.com |
Website: www.gud-knight.com | Website: www.gud-knight.com |
References
- NERLYNX® (neratinib) tablets. Product Monograph,
June 2021 . - Canadian Cancer Statistics, 2020.
Toronto, ON :Canadian Cancer Society ; 2020. Available at: https://action.cancer.ca/en/research/cancer-statistics/canadian-cancer-statistics - Saura, C.,
Oliveira , M., Feng, Y. H., Dai, M. S., Chen, S. W., Hurvitz, S. A., ... & NALA Investigators. (2020). Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with≥ 2 HER2-directed regimens: phase III NALA trial.Journal of Clinical Oncology , 38(27), 3138. - Perez, E. A., Romond, E. H., Suman, V. J., Jeong, J. H., Sledge, G.,
Geyer Jr ,C. E ., ... & Wolmark, N. (2014). Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2–positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831.Journal of Clinical Oncology , 32(33), 3744. - Goldhirsch, A., Gelber, R. D., Piccart-Gebhart, M. J., De Azambuja, E.,
Procter , M., Suter, T. M., ... & Herceptin Adjuvant (HERA) Trial Study Team. (2013). 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial.The Lancet , 382(9897), 1021-1028.
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