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