On January 22, AstraZeneca (AZN.US) announced that IMFINZI (generic name: durvalumab) had been approved by the National Medical Products Administration (NMPA) of China.
According to Zhitong Finance, on January 22, AstraZeneca (AZN.US) announced that IMFINZI (generic name: durvalumab) had been approved by the National Medical Products Administration (NMPA) of China for use in combination with carboplatin and paclitaxel as a first-line treatment for adult patients with mismatch repair-deficient (dMMR) primary advanced or recurrent endometrial cancer, followed by maintenance therapy with this product alone.
Durvalumab is a humanized PD-L1 monoclonal antibody that binds to the PD-L1 protein, blocking its interaction with PD-1 and CD80 proteins, thereby preventing tumor immune escape and restoring suppressed immune responses. To date, this drug has been approved for 10 indications in the United States, 11 indications in the European Union, and 7 indications domestically.
The approval of durvalumab in China this time was based on the pre-specified subgroup analysis results according to MMR status from the DUO-E Phase 3 trial. The DUO-E trial (GOG 3041/ENGOT-EN10) is a three-arm, randomized, double-blind, placebo-controlled, multicenter Phase 3 trial comparing first-line durvalumab combined with platinum-based chemotherapy (carboplatin and paclitaxel), followed by either durvalumab monotherapy or durvalumab combined with olaparib as maintenance therapy, versus platinum-based chemotherapy alone, in newly diagnosed advanced or recurrent endometrial cancer patients.
In the trial, compared to treatment with carboplatin and paclitaxel, treatment with durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab monotherapy as maintenance treatment, reduced the risk of disease progression or death by 58% in dMMR endometrial cancer patients. The median progression-free survival (PFS) in the durvalumab group has not yet been reached, while the median PFS in the control group was 7.0 months.
In terms of safety, the overall safety and tolerability of the durvalumab combination chemotherapy regimen were good and generally consistent with previous clinical trial results, with no new safety signals identified.
