Immuno-oncology company AstraZeneca (LSE: AZN) (STO: AZN) (Nasdaq: AZN) announced on Monday that Imfinzi (durvalumab), combined with carboplatin and paclitaxel followed by Imfinzi monotherapy, has received US FDA approval for treating mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. Approval is based on the DUO-E Phase III trial, which showed Imfinzi reduced disease progression or death risk by 58% compared to chemotherapy alone.

The DUO-E trial, results of which were published in the Journal of Clinical Oncology, demonstrated significant benefits for patients with dMMR endometrial cancer. In this study, Imfinzi combined with chemotherapy showed a hazard ratio of 0.42, highlighting its effectiveness.

Endometrial cancer, the fourth most common cancer in US women, had over 66,000 diagnoses and nearly 12,000 deaths in 2022. Early-stage patients have an 80-90% five-year survival rate, but advanced disease survival drops below 20%.

The safety profile of the Imfinzi regimen was manageable and consistent with prior trials. The trial also included an arm combining Imfinzi with Lynparza (olaparib), which met the primary endpoint of progression-free survival, with overall survival results still being assessed.

Imfinzi, a monoclonal antibody targeting the PD-L1 protein, is already approved for several cancers, including NSCLC and biliary tract cancer. It is being tested for various solid tumours in a broad development programme.

AstraZeneca, headquartered in Cambridge, UK, continues to innovate in immuno-oncology, aiming to transform cancer care. Its comprehensive pipeline seeks to address some of the most challenging cancers, striving to redefine cancer treatment and ultimately eliminate cancer as a cause of death.