Lynparza and Imfinzi Combination Recommended for EU Approval in Endometrial Cancer Treatment

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) for the treatment of primary advanced or recurrent endometrial cancer. This recommendation is based on the DUO-E Phase III trial results, which showed significant benefits for patients with mismatch repair proficient (pMMR) and mismatch repair deficient (dMMR) disease.

For pMMR patients, the combination of Imfinzi plus chemotherapy followed by Lynparza and Imfinzi showed a 43% reduction in the risk of disease progression or death compared to the control arm. Similarly, for dMMR patients, Imfinzi plus chemotherapy followed by Imfinzi alone resulted in a 58% reduction in the risk of disease progression or death.

Endometrial cancer is the fourth most common cancer in women in Europe, with a significant need for new treatment options, especially for the 70-80% of patients with pMMR disease. The recommendation highlights the importance of MMR testing at diagnosis, which is crucial for determining the most effective treatment strategy.

The safety profiles of both treatment regimens were manageable and well-tolerated, consistent with the known profiles of the individual agents. Regulatory submissions for Imfinzi and Lynparza are under review in Japan and several other countries, with Imfinzi plus chemotherapy already approved for dMMR patients in the US.

This development represents a critical step forward in improving outcomes for patients with advanced or recurrent endometrial cancer, offering new hope and treatment options for those with limited alternatives.