AstraZeneca PLC Sponsored ADR (AZN.US) announces approval of a new indication for PD-L1 antibody in China for the treatment of endometrial cancer.

On January 22nd, Astrazeneca PLC Sponsored ADR (AZN.US) announced that Imfinzi (Durvalumab), has been approved by the National Medical Products Administration (NMPA) in China for use in combination with carboplatin and paclitaxel as first-line treatment for adult patients with advanced or recurrent mismatch repair deficient (dMMR) primary late-stage or recurrent endometrial cancer, followed by maintenance treatment with Durvalumab alone. Durvalumab is a humanized PD-L1 monoclonal antibody that binds to the PD-L1 protein, blocking the interaction with PD-1 and CD80 proteins, thereby preventing tumor immune evasion and restoring suppressed immune responses. The drug has been approved for 10 indications in the US, 11 indications in the EU, and 7 indications in China. The approval of Durvalumab in China was based on a subgroup analysis from the DUO-E Phase 3 trial according to MMR status. The DUO-E trial (GOG 3041/ENGOT-EN10) is a three-arm, randomized, double-blind, placebo-controlled, multicenter Phase 3 trial that uses Durvalumab in combination with platinum-based chemotherapy (carboplatin and paclitaxel) as first-line treatment, followed by maintenance treatment with Durvalumab alone or in combination with olaparib, compared to platinum-based chemotherapy alone for newly diagnosed advanced or recurrent endometrial cancer patients. In the trial, the combination of Durvalumab with carboplatin and paclitaxel, followed by maintenance treatment with Durvalumab alone, reduced the risk of disease progression or death by 58% in dMMR endometrial cancer patients compared to treatment with carboplatin and paclitaxel alone. The median progression-free survival (PFS) for the Durvalumab group has not been reached, while the median PFS for the control group was 7.0 months. In terms of safety, the overall safety and tolerability of the Durvalumab combination therapy with chemotherapy was good and consistent with previous clinical trial results, with no new safety signals observed.