AstraZeneca's PD-L1 Inhibitor Durvalumab Approved in China for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

According to the latest announcement from China's National Medical Products Administration (NMPA), the new indication application for AstraZeneca's PD-L1 inhibitor durvalumab (brand name: Imfinzi) has been approved in China. The new indication is for use in combination with etoposide and platinum-based chemotherapy (carboplatin or cisplatin) as first-line treatment for extensive-stage small cell lung cancer. Previously, the drug was approved in China for the treatment of patients with unresectable, stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiotherapy.

Source: NMPA Official Website

Durvalumab is a humanized anti-PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby inhibiting tumor immune evasion and releasing suppressed immune responses. The drug has been approved for marketing in multiple countries and regions worldwide, with indications including stage III unresectable non-small cell lung cancer, extensive-stage small cell lung cancer, and advanced bladder cancer, among others.

It is reported that this approval is based on the positive results of a Phase 3 clinical trial named CASPIAN. The study showed that the median overall survival (OS) in the durvalumab combination therapy group was higher than that in the chemotherapy-alone group (13.0 months vs. 10.3 months); compared with the chemotherapy-alone group, the durvalumab plus chemotherapy group reduced the risk of death by 27%. Furthermore, the results from the Chinese cohort were consistent with those of the overall population.

The 2-year overall survival rate (OS%) in the durvalumab plus chemotherapy group was 22.2%, with nearly one-quarter of patients achieving a survival benefit of more than 2 years; consistent benefits were observed across all subgroups (carboplatin- or cisplatin-based combinations / brain metastasis populations). The 1-year progression-free survival rate (PFS%) in the durvalumab plus chemotherapy group was more than three times that of the chemotherapy-alone group. The objective response rate (ORR) in the durvalumab plus chemotherapy group was 68%, representing a 10-percentage-point improvement over the chemotherapy-alone group (58%). Furthermore, the safety and tolerability profile of durvalumab combined with chemotherapy was consistent with the known safety profiles of these agents.

Responsible Editor: Liuli

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