AstraZeneca's PD-L1 Inhibitor Durvalumab Approved in China for Limited-Stage Small Cell Lung Cancer

On June 4, AstraZeneca announcedAnti-PD-L1 Monoclonal AntibodyDurvalumabApproved by the National Medical Products Administration (NMPA) of China for a new indication,As a single agent for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after receiving platinum-based chemoradiotherapy.. This approval is based on the positive results of the ADRIATIC Phase 3 clinical trial. Previously, the data from the ADRIATIC global clinical trial was successfully published in The New England Journal of Medicine (NEJM); The results of its China cohort study have been announced at the European Lung Cancer Conference (ELCC) earlier this year.

Small cell lung cancer is a highly aggressive type of lung cancer. Despite limited-stage small cell lung cancer(LS-SCLC, Stage I-III)Patients respond to initial chemotherapy and radiotherapy, but they still relapse and progress rapidly. The prognosis of patients with limited-stage small cell lung cancer is extremely poor, with only 15-30% surviving beyond 5 years after diagnosis.

Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby preventing tumor immune escape and restoring suppressed immune responses.

Professor Cheng Ying, a member of the Global Steering Committee and the principal investigator in China for the ADRIATIC clinical trial, stated that there has been minimal progress in the treatment of limited-stage small cell lung cancer over recent decades.In the ADRIATIC trial, patients treated with durvalumab showed significant overall survival benefits, with a three-year overall survival rate as high as 57%. Durvalumab is expected to become a new treatment standard in China and even globally.。

The test results showed that,Compared with placebo, durvalumab reduced the risk of death by 27%。The estimated median overall survival in the durvalumab monotherapy group was 55.9 months., while the placebo group was only 33.4 months. The estimated three-year overall survival rate for patients receiving durvalumab monotherapy is 57%, while the placebo group is 48%.

Compared with placebo, durvalumab reduced the risk of disease progression or death by 24%The median progression-free survival was 16.6 months in the durvalumab monotherapy group and 9.2 months in the placebo group. It was estimated that 46% of patients receiving durvalumab had not experienced disease progression at two years, compared with 34% in the placebo group.

Moreover, the data from the ADRIATIC China cohort study show that the overall survival (OS) and progression-free survival (PFS) benefits in the Chinese patient population are consistent with the overall results of the global study, indicatingCompared with placebo, durvalumab reduced the risk of death by 29% and the risk of disease progression or death by 33%.。

Previously, based on the results of the ADRIATIC study, durvalumab has also been approved for this indication in the United States, the European Union, Japan, and other countries or regions. Based on the CASPIAN Phase III trial, durvalumab has also been approved in combination with chemotherapy for the treatment of extensive-stage small cell lung cancer.

References:

[1]Imfinzi® Approved in China as the First and Only* Immunotherapy for the Treatment of Limited-Stage Small Cell Lung Cancer.From https://www.prnasia.com/story/491698-1.shtml