Core Insights - AstraZeneca's durvalumab (brand name: Imfinzi) has been approved for a new indication in China, becoming the first and only immunotherapy for the treatment of limited-stage small cell lung cancer (LS-SCLC) in adult patients who have not experienced disease progression after platinum-based chemoradiotherapy [1][2] - The approval is based on positive results from the ADRIATIC Phase III clinical trial, which demonstrated significant overall survival benefits, with a three-year overall survival rate of 57% for patients treated with durvalumab [1] - The trial results were published in a top-tier medical journal and presented at a major oncology conference, confirming the efficacy of durvalumab in the Chinese patient population [1][2] Group 1 - The ADRIATIC trial showed that the median progression-free survival for the durvalumab treatment group was 16.6 months compared to 9.2 months for the placebo group [1] - 46% of patients receiving durvalumab did not experience disease progression at two years, compared to 34% in the placebo group [1] - The Chinese cohort's overall survival and progression-free survival benefits were consistent with global study results, indicating a 29% reduction in the risk of death and a 33% reduction in the risk of disease progression or death compared to placebo [1][2] Group 2 - Approximately 34,000 patients in China are treated for limited-stage small cell lung cancer each year, with a poor prognosis where only 15%-30% survive beyond five years [2] - The approval of durvalumab marks a significant advancement in treatment options for LS-SCLC, which has seen little progress in recent decades [2] - Durvalumab has also been approved in the US, EU, and Japan for the same indication, and it is approved for use in combination with chemotherapy for extensive-stage small cell lung cancer based on the CASPIAN Phase III trial [3]
度伐利尤单抗在华获批新适应症,治疗局限期小细胞肺癌