AstraZeneca Secures Landmark EU Approval for Imfinzi-Lynparza Combo in Endometrial Cancer Treatment

Approval Details:

AstraZeneca has received the first regulatory approval in the European Union (EU) for the combination therapy of Imfinzi (durvalumab) and Lynparza (olaparib) for treating certain patients with primary advanced or recurrent endometrial cancer.

Treatment Regimens:

The approved regimen includes Imfinzi plus chemotherapy as a first-line treatment, followed by Lynparza and Imfinzi for patients with mismatch repair proficient (pMMR) tumors.
For patients with mismatch repair deficient (dMMR) disease, the approved regimen is Imfinzi plus chemotherapy followed by Imfinzi alone.

Clinical Benefits:

The combination therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy alone.
For pMMR patients, the risk of disease progression or death was reduced by 43%.
For dMMR patients, the risk of disease progression or death was reduced by 58%.

Clinical Trial Data:

The approvals were based on data from the Phase III DUO-E study, which showed significant efficacy and manageable safety profiles for both regimens.

Market Impact:

This approval marks the first-ever combination of an immunotherapy and a PARP inhibitor for endometrial cancer, providing new treatment options for patients with advanced or recurrent disease.
Regulatory submissions for this combination are also under review in Japan and several other countries.

Expert Insights:

Els Van Nieuwenhuysen, a gynaecological oncologist, highlighted the significant benefit of this combination for patients with both pMMR and dMMR disease, emphasizing the need for MMR testing at diagnosis.
Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, noted the potential of this combination to provide clinical benefit, especially for pMMR patients who have limited treatment options.