K drug was approved for the tenth indication, and immunotherapy drugs for the treatment of early triple-negative breast cancer were approved in China

In November 2022, during the Expo, another heavy news ushered in! The immune checkpoint inhibitor pembrolizumab (commonly known as "K drug", trade name: KEYTRUDA ^®️) developed by Merck was officially obtained by the National Medical Products Administration (NMPA).
NMPA) approved neoadjuvant therapy in combination with chemotherapy and continued adjuvant pembrolizumab monotherapy after surgery for well-validated assays to assess tumor expression of PD-L1 (composite positive score (CPS≥20).
Treatment of patients with early-stage high-risk triple-negative breast cancer
.
This is the 10th indication for pembrolizumab approved in China since it was first approved for marketing in China in 2018
.

Pembrolizumab is the first immune checkpoint inhibitor approved globally for the treatment of triple-negative breast cancer, marking the beginning of triple-negative breast cancer immunotherapy
.
Approval in China also means that it provides a better treatment option
for patients with early-stage triple-negative breast cancer in China.

The needs of triple-negative breast cancer treatment are yet to be met, and innovative solutions are urgently needed in clinical practice

Breast cancer is one of the common malignant tumors in women, and the incidence of female malignant tumors ranks first, seriously endangering women's physical and mental ^health1
.
According to a report released by the World Health Organization's International Agency for Research on Cancer (IARC), the number of new cases of breast cancer worldwide in 2020 was as high as 2.
26 million, of which about 15%~20% of breast cancer, estrogen receptor ( ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2) are all negative and are called triple-negative breast cancer
.

Triple-negative breast cancer has the worst prognosis of all subtypes of breast cancer, has a young age of onset, tends to occur in premenopausal women under 40 years of ^age2, is aggressive, and is prone to local recurrence and distant metastasis3
。 Clinical findings have shown that patients with early triple-negative breast cancer have a peak recurrence 2-3 years after ^surgery4, which brings a great burden
of disease to young and middle-aged women.

Due to the lack of effective therapeutic targets for early triple-negative breast cancer, current treatment options are very limited
.
Therefore, for patients with this subtype of breast cancer, it is urgent to explore innovative solutions to improve the overall treatment effect and improve patient survival
.

Breakthrough therapies break the therapeutic dilemma and immunotherapy significantly improves patient survival

The approval of the new indication is based on data from the Phase III clinical trial KEYNOTE-522, a randomized, double-blind, placebo-controlled, III study A phase clinical trial to evaluate the efficacy
of pembrolizumab in combination with chemotherapy for neoadjuvant therapy and subsequent pembrolizumab monotherapy for adjuvant therapy, versus chemotherapy for neoadjuvant therapy and subsequent placebo for adjuvant therapy in patients with early-stage high-risk triple-negative breast cancer.

According to the KEYNOTE-522 study, pembrolizumab combined with neoadjuvant chemotherapy with sequential pembrolizumab adjuvant therapy for early high-risk triple-negative breast cancer significantly improved the pathologic complete response rate (pCR) and event-free survival (EFS) in patients
。 In patients with PD-L1 (Composite Positive Score (CPS) ≥20), the pCR in the pembrolizumab group increased from 62.
5% compared with the control group It increased to 81.
7%, and the EFS rate in 24-month follow-up data increased from 86.
5% to 95.
1% , all have reached significant improvement
.
In addition, the risk of disease recurrence, progression, or death was reduced by 38%
in the pembrolizumab group compared with the placebo group.

It is worth noting that the KEYNOTE-522 study is the largest study of immunotherapy combined with chemotherapy (neo) adjuvant therapy for early triple-negative breast cancer, and the only study that has achieved all positive results, and the results have been published twice in the top international journal "New England Journal of Medicine" (NEJM), which has attracted extensive attention from domestic and foreign counterparts
。

"Due to the lack of effective therapeutic targets for early-stage triple-negative breast cancer, current treatment options are very limited
.
After regular large-scale treatment, 30%-40% of patients still develop relapse and metastasis6^, and there is an urgent medical need to be met," said Professor Shao Zhimin, Director of Breast Surgery, Fudan University Cancer Hospital The approval of the new indication of pembrolizumab has opened a new era of breast cancer tumor immunotherapy, which may change the treatment pattern of patients with early triple-negative breast cancer and provide clinicians and patients with new treatment options
.
”

Benefiting the health and well-being of women in China, we will usher in a new era of cancer treatment and possible cure

The most beautiful Lin Daiyu actor Chen Xiaoxuxiang died of jade, the famous singer Yao Beina died with hatred, and the wife of the famous online novel writer Tang Jia Sanshao died with the wind, and the culprits were all three-negative breast cancer
.

In the past few decades, due to the lack of effective treatment for triple-negative breast cancer, many patients will panic once diagnosed with triple-negative breast cancer, which will bring people not only physical but also mental health serious impact
.

"The approval of the new indication of pembrolizumab in China opens a new journey of tumor immunotherapy in the field of breast cancer, which 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 The journey of benefiting Chinese patients with 10 indications highlights Merck's commitment to the most urgent health challenges of Chinese women, from vaccines, targeted drugs to tumor immunotherapy, and multi-layered defense to benefit patients with cervical, ovarian and breast cancer, protecting the health of thousands of
Chinese women and their families in an all-round way.
”

"Early detection and treatment of cancer helps patients achieve a greater chance of long-term survival, and many cancers are currently considered treatable and potentially curable in the early stages of the disease," said Dr.
Li Zhengqing, senior vice president and president of Merck's China R&D Center Merck oncology products have revolutionized the treatment of many advanced cancers, and we are very excited to see the approval
of this indication for early-stage high-risk triple-negative breast cancer in China.
" 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.
”

With the approval of pembrolizumab in China, it has broken the traditional treatment pattern of triple-negative breast cancer, which will bring more treatment benefits to patients, promote triple-negative breast cancer into a new era of immunotherapy, and look forward to the early arrival of the era of cancer treatment and possible cure.

References:

1, Chinese Health Commission, Guidelines for the diagnosis and treatment of breast cancer (2022 edition).

2，Bauer KR, et al.
Cancer.
2007; 1091721–1728

3，Dent R, et al.
Clin Cancer Res.
2007; 13(15 Pt 1):4429-4434.

4, China Breast Cancer Neoadjuvant Therapy Expert Group Expert consensus on neoadjuvant therapy for breast cancer in China (2019 edition).
Chinese Journal of Oncology,2019,29(5):390-400.
doi: 10.
19401/j.
cnki.
1007-3639.
2019.
05.
009

5，Foulkes WD, et al.
N Engl J Med.
2010; 363(20)1938-1948.

6，Won KA, et al.
Int J Oncol.
2020; 57(6):1245-1261.

7, Xiu Meng, Zhang Pin Research progress on treatment models and neoadjuvant therapy for early triple-negative breast cancer Cancer Prevention and Treatment Research, 2020, 47(2): 129-134