On June 25, 2026, Merck announced that its PD-1 inhibitor pembrolizumab (brand name: Kreida ®) has received approval from China's National Medical Products Administration (NMPA) for the use of a well-validated test to evaluate the treatment of adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received first- or second-line systemic therapy who have expressed PD-L1 (Composite Positive Score (CPS)≥1). The approval of this new indication is based on data from the Phase III clinical trial KEYNOTE-B96 (ENGOT-ov65).
Ovarian cancer is one of the common malignant tumors in women's areas in China. According to the latest data from the National Cancer Center, in 2024, there were about 61,900 new cases of ovarian cancer and approximately 32,500 deaths in China, ranking third in incidence and second in mortality among malignant tumors of the female reproductive system in China. Due to the lack of effective screening methods and atypical early symptoms, about 70% of patients are diagnosed with advanced stages. Despite standard treatment, about 70% of patients still experience relapse, and relapses often lead to platinum resistance, presenting significant challenges in treatment. Clinical treatment urgently needs to explore new therapeutic strategies.
Previously, its PD-1 inhibitor pembrolizumab (Keytruda) received FDA approval for a new indication.
The KEYNOTE-B96 study showed that among 466 PD-L1 positive tumor patients with CPS scores of ≥1, the median PFS was 8.3 months in the pembrolizumab group and 7.2 months in the placebo group (HR=0.72; p=0.0014). The median OS for the pembrolizumab group was 18.2 months, and the median overall survival for the placebo group was 14.0 months (HR=0.76; p=0.0053).
Pembrolizumab is an anti-PD-1 monoclonal antibody developed by Merck. Since receiving FDA approval in 2014, the product has been approved for dozens of indications worldwide, covering at least 16 types of cancer including melanoma, head and neck cancer, and non-small cell lung cancer. In China, pembrolizumab has been approved for 20 indications.
Content sources: Merck China WeChat public account, Sina Pharma
Editor:lucy