Merck's PD-1 inhibitor KEYTRUDA (R) was approved for a new indication for the treatment of triple-negative breast cancer in China

The first tumor immunotherapy drug approved in China for the treatment of patients with early-stage high-risk triple-negative breast cancer, opening a new era of breast cancer immunotherapy

SHANGHAI, Nov.
9, 2022 /PRNewswire/ -- Merck (Merck's corporate trade name Merck & Co.
in Lowe City, New Jersey) announces that its PD-1 inhibitor, pembrolizumab (trade name: KEYTRUDA ®?), has been approved by the National Medical Products Administration (NMPA) in combination with chemotherapy neoadjuvant therapy and continues to be treated with pembrolizumab monotherapy after surgery.
For the treatment
of patients with early-stage high-risk triple-negative breast cancer (TNBC) who have been evaluated by a well-validated assay to evaluate tumors expressing PD-L1 (composite positive score (CPS) ≥20).
The approval of the new indication is based on data
from the Phase III clinical trial KEYNOTE-522 study.

"The approval of the new indication of pembrolizumab in China opens a new journey of tumor immunotherapy in the field of breast cancer, and is expected to bring new choices and hopes to more patients and families," said Anna Tian, Senior Vice President of Merck and President of Merck China, "This milestone not only represents the journey of 10 indications of pembrolizumab to benefit Chinese patients, but also highlights Merck's commitment to addressing the most pressing health challenges of Chinese women, from vaccines to From targeted drugs to tumor immunotherapy, the multi-layered line of defense benefits patients with cervical, ovarian and breast cancer, and protects the health of thousands of
Chinese women and their families.
"

Breast cancer is one of the common malignant tumors in women, and the incidence ranks first among female malignant tumors, seriously endangering women's physical and mental health ^[1].

Triple-negative breast cancer (TNBC) is a subtype of breast cancer with negative expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2^{) [2}], and is the worst prognosis of all subtypes of breast cancer [3], which tends to occur in women under 40 years of age [^4], usually shows more aggressiveness, is prone to early recurrence and metastasis, and has a poor prognosis ^{[ 2]}
。 The risk of TNBC recurrence peaks rapidly one to three years after diagnosis, and the risk of death within five years is higher than that of other types of breast cancer ^[5], resulting in a significant disease burden
for patients.

"Due to the lack of effective therapeutic targets for early TNBC, the current treatment methods are very limited
.
After regular large-scale treatment, 30%-40% of patients still have relapse and metastasis ^[2], and there is an urgent medical need to be met," said Professor Shao Zhimin, director of breast surgery at Fudan University Cancer Hospital, "The approval of the new indication of pembrolizumab has opened a new era of breast cancer immunotherapy, or will change the treatment pattern of patients with early triple-negative breast cancer and provide clinicians and patients with new treatment options
。 "

"Early detection and treatment of cancer helps patients achieve a greater chance of long-term survival, and many cancers are now considered treatable and potentially curable in the early stages of the disease," said Dr
.
Li Zhengqing, Senior Vice President and President of Merck China R&D Center 。 At present, the company has carried out about 20 registration studies for multiple cancer types, and will continue to explore the research and application
of pembrolizumab in early cancer treatment.
"

If you would like to learn more about the disease, consult a healthcare professional at 11-2022-CN-OBR-00002