AstraZeneca (AZN) has announced that its combination therapy of Imfinzi (durvalumab), a PD-L1 inhibitor, and Lynparza (olaparib), a PARP inhibitor, has received approval in the European Union (EU) for treating specific patients with primary advanced or recurrent endometrial cancer, also known as uterine cancer.
The approved patient groups are those with mismatch repair proficient (pMMR) disease who will receive Imfinzi plus chemotherapy as a first-line treatment followed by Lynparza and Imfinzi. Patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer are also eligible, receiving Imfinzi plus chemotherapy followed by Imfinzi monotherapy.
This EU approval follows the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July 2024. The CHMP recommended the Lynparza and Imfinzi combination for pMMR patients and Imfinzi plus chemotherapy followed by Imfinzi alone for dMMR patients.
The approval is based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study. This study demonstrated that the Lynparza plus Imfinzi combo reduced the risk of disease progression or death by 43% in pMMR patients compared to the control group. Meanwhile, the Imfinzi plus chemotherapy arm showed a 58% reduction in the risk of disease progression or death for dMMR patients compared to the control group.
Importantly, the safety profiles of both regimens were found to be manageable and well-tolerated.
This approval marks a significant milestone for AstraZeneca, representing the first-ever approval for a combination of immunotherapy and PARP inhibitor in endometrial cancer. Endometrial cancer is the fourth most common cancer in women within the EU, with 70% to 80% of patients having pMMR disease. This approval provides a crucial treatment option for these patients who previously had limited treatment choices.
In June, Imfinzi plus chemotherapy, followed by Imfinzi monotherapy, was approved in the United States for treating adult patients with dMMR advanced or recurrent endometrial cancer, also based on data from the DUO-E study. Regulatory applications for the Imfinzi plus Lynparza regimen are currently under review in Japan and other countries, with the aim of including data from the DUO-E study on Imfinzi’s label.
Both Imfinzi and Lynparza are key revenue drivers for AstraZeneca’s oncology portfolio. In the first half of 2024, Imfinzi generated $2.26 billion in sales, representing a 25% year-over-year increase at constant exchange rates. During the same period, Lynparza product revenues rose 9% year over year at constant exchange rates to $1.45 billion.
It’s important to note that AstraZeneca markets Lynparza in partnership with Merck (MRK). The two companies entered into a profit-sharing agreement in 2017 to co-market Lynparza and Koselugo. AstraZeneca and Merck’s Lynparza is currently approved for treating four cancer types: ovarian, breast, prostate, and pancreatic. Additionally, Lynparza is being evaluated in late-stage studies for lung cancer indications, in combination with Merck’s Keytruda.
