FDA approves Mercado PD-1 inhibitor Keytruda for treatment of patients with esophageal squamous cell carcinoma

today, the u.SFDA(http://approved the company's heavy-duty PD-1 inhibitor Keytruda as a single-drug therapy for patients with recurrent late-stage or metastatic esophageal squamous cell carcinoma, thehttp://
company of MSD announced todayAbout Keytruda
Keytruda is a human-derived anti-PD-1 monoantigen developed by MercadoIt improves the body's immune system's ability to detect and kill cancer cells by blocking the binding of PD-1 receptors to PD-L1 and PD-L2Since being first approved for advanced melanoma in 2014, Keytruda has been approved for more than 20 indications, including lung cancer, head and neck carcinoma, stomach cancer and hepatocellular carcinomaIn China, Keytruda has been approved for the treatment of melanoma and non-squamous non-small cell lung cancerThe approval for the relevant clinical trialis based on theresults of a clinicaltrial(http:// called KEYNOTE-181 and KEYNOTE-180 　　In open label, a randomized Phase 3 clinical trial with active controls, KEYNOTE-181, 628 patients with recurrent prestage or metastatic esophageal cancer were treated with Keytruda or chemotherapy 　　The results showed that the median total lifetime (OS) in the Keytruda group was 10.3 months in ESCC patients with tumor expression PD-L1 (CPS-10) and 6.7 months in the chemotherapy group (HR-0.64,95% CI: 0.46, 0.90) 　　The objective remission rate (ORR) was 22% in the Keytruda group, 5% for the full remission rate (CRR), and 7% for the chemotherapy group and 1% for the chemotherapy group The median remission duration (DOR) in the Keytruda group was 9.3 months and the chemotherapy group was 7.7 months 　　In a non-randomized, open-label Phase 2 clinical trial called KEYNOTE-180, 121 patients with localized advanced or metastatic esophageal cancer who received at least two pre-system therapies were treated with Keytruda In ESCC patients with tumor expression PD-L1, THE ORR R was 20%