September 23, 2021 (Shanghai, China) – Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the China National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for pyrotinib in combination with trastuzumab and docetaxel as a new neoadjuvant therapy regimen in early-stage or locally advanced HER2-positive breast cancer patients. The NDA is supported by data from a multicenter, randomized, and placebo-controlled Phase III trial, HR-BLTN-III-NeoBC, which met the primary endpoint of total pathological complete response (tpCR).

About the Study

The Phase III HR-BLTN-III-NeoBC study enrolled 355 patients from 17 sites, who were randomized 1:1 to receive either pyrotinib plus trastuzumab and docetaxel or placebo plus trastuzumab and docetaxel for up to 4 cycles (each cycle lasting 21 days). The primary endpoint was tpCR based on Independent Review Committee (IRC) evaluation. The secondary endpoints included tpCR based on investigator evaluation, event-free survival, disease-free survival, distant metastasis-free survival, objective response rate, and safety. The data demonstrated that the addition of pyrotinib to trastuzumab and docetaxel as a new neoadjuvant therapy regimen significantly increased the tpCR rate in early-stage or locally advanced HER2-positive breast cancer patients.

About Breast Cancer

Breast cancer is the most common type of cancer worldwide in 2020.¹ According to the GLOBOCAN 2020 report, there were approximately 2.26 million new breast cancer cases (including 253,465 cases in the United States and 531,086 cases in Europe) and approximately 685,000 breast cancer deaths worldwide. HER2-positive breast cancer, which accounts for approximately 15-20%² of breast cancers, tends to grow and spread faster than other types.³ The neoadjuvant approach has become a standard therapy option for early-stage HER2-positive breast cancer to improve disease-free survival and overall survival.²

About Pyrotinib

Pyrotinib is a novel irreversible and selective EGFR/HER2 tyrosine kinase inhibitor developed by Hengrui. In 2018, pyrotinib was approved in China in combination with capecitabine for the treatment of relapsed or metastatic HER2-positive breast cancer. Currently, two Phase III studies are ongoing to evaluate pyrotinib as 1st-line treatment (NCT03863223) and extended adjuvant treatment (NCT03980054), respectively in HER2-positive breast cancer patients.

In addition to breast cancer, pyrotinib demonstrated superior clinical benefits in advanced non-small cell lung cancer (NSCLC) with HER2 exon 20 mutation in a Phase II study. A global Phase III study (NCT04447118) is ongoing to investigate pyrotinib in patients with advanced non-squamous NSCLC with HER2 exon 20 mutation who previously failed platinum-based chemotherapy.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

BD Contact

Email: bd@hengrui.com

Phone: +86-21-61053532

1. https://www.bcrf.org/breast-cancer-statistics-and-resources

2. Sibylle Loibl, Luca Gianni (June 2017). HER2-positive breast cancer. The Lancet. 389 (10087): 2415-2429.

3. https://www.cancer.org/cancer/breast-cancer/