Express | Treatment of early-stage triple-negative breast cancer patients, blockbuster PD-1 inhibitors reach dual phase 3 clinical endpoints

▎ WuXi AppTec content team editor May 13th, Merck & Co.
(MSD) announced that its blockbuster anti-PD-1 therapy Keytruda in the treatment of high-risk early triple-negative breast cancer (TNBC) patients in the pivotal phase 3 clinical trial KEYNOTE-522 Reached the dual primary endpoint.

In this study, Keytruda was used in combination with chemotherapy as a neoadjuvant treatment before resection surgery, and continued as a single-agent adjuvant treatment after surgery.

Based on an interim analysis conducted by the Independent Data Monitoring Committee (DMC), this treatment plan provides a statistically and clinically significant improvement in event-free survival (EFS) compared with neoadjuvant chemotherapy alone.

Event-free survival refers to the patient's survival without the following events, including cancer progression that makes surgery impossible, any form of cancer recurrence, the appearance of another primary tumor, and death from any cause.

TNBC patients account for 15-20% of breast cancer patients, and it is more common in women under the age of 40.

Because it does not express estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (HER2), patients cannot receive targeted therapy targeting these receptors, and treatment options are limited.

TNBC is one of the most dangerous types of breast cancer.
It is highly invasive, easy to metastasize, and has a very poor prognosis.
The survival period of patients after diagnosis is usually no more than 20 months, and the 5-year survival rate is less than 15%.

Keytruda is an anti-PD-1 therapy, which increases the body's immune system's ability to detect and fight tumor cells by blocking the immunosuppressive signal mediated by PD-1.

Keytruda can block the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes.

Since its inception, this drug has been approved by the FDA to treat more than 30 indications such as melanoma and non-small cell lung cancer.

Previously, Merck had reported that this trial reached the primary clinical endpoint of pathological complete remission (pCR, defined as no aggressive residual cancer found in the breast and nearby lymph node tissue after surgery).

64.
8% of patients who received the combination therapy of Keytruda and chemotherapy achieved pCR, compared with 51.
2% in the chemotherapy control group.

It is important that the clinical benefits of Keytruda as a neoadjuvant therapy are not related to the expression of PD-L1 in cancer.

"Keytruda is the first anti-PD-1 therapy that has shown an event-free survival benefit in high-risk early TNBC patients," said Dr.
Roy Baynes, Chief Medical Officer of Merck Laboratories and head of global clinical development: "Initially after preoperative treatment The observed improvement in the pathological complete remission rate is encouraging.
The mature data we have observed now include statistically significant improvements in event-free survival.
We look forward to working with the US FDA and other global regulatory agencies to bring this to patients as soon as possible.
A new treatment option.

"References: [1] Merck Announces Phase 3 KEYNOTE-522 Trial Met Dual Primary Endpoint of Event-Free Survival (EFS) in Patients With High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC).
Retrieved 2021-05-13, from Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.

If you need guidance on treatment plans, please go to a regular hospital for treatment.