A few days ago, the European Commission announced the approval of Merck’s anti-PD-1 therapy Keytruda combined with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults with tumors.

Just a month ago, the combination of Keytruda and chemotherapy for triple-negative breast cancer has just received a positive recommendation from the European Medicines Agency (EMA) Committee on Medicines for Human Use (CHMP). The company said in a statement last Friday that patients with indications require PD-L1 to be positive and have not previously received chemotherapy for metastatic disease.

Triple-negative breast cancer is an aggressive breast cancer. It is a type of breast cancer that is negative for overexpression of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2). The feature of this disease is to diagnose The recurrence rate is very high in the first 5 years, and approximately 10% to 15% of breast cancer patients are diagnosed with TNBC.

The approval is based on the positive results of the pivotal Phase 3 KEYNOTE-355 trial (NCT02819518). KEYNOTE-355 (NCT02819518) is a randomized, placebo-controlled phase 3 trial that evaluated Keytruda in locally recurring unresectable or metastatic triple-negative breast cancer (TNBC) patients who had not previously received chemotherapy for advanced disease. Combination chemotherapy (one of 3 chemotherapy regimens), placebo combined chemotherapy (one of 3 chemotherapy regimens) for the efficacy and safety of first-line treatment.

The results of the KEYNOTE-355 trial showed that compared with patients who received chemotherapy alone, PFS and OS were significantly improved in patients who received Keytruda combined with chemotherapy. Keytruda combined with chemotherapy significantly improved the overall survival rate of subjects, reduced the risk of death by 27%, and slowed the progression of the disease. Compared with chemotherapy alone, the mortality of patients with Keytruda combined with chemotherapy was reduced by 34%.

The Keytruda combination chemotherapy has been approved for the treatment of breast cancer and will allow Keytruda to be marketed and marketed in all 27 EU member states as well as Iceland, Liechtenstein, Norway and Northern Ireland. This is also the first time that Keytruda has been approved for the treatment of breast cancer in the EU.