AstraZeneca endometrial cancer treatment recommended for EU approval

AstraZeneca announced on Monday that ‘Imfinzi’, or durvalumab, and ‘Lynparza’, or olaparib, have received a recommendation for approval in the European Union (EU) as treatments for primary advanced or recurrent endometrial cancer in patients with specific genetic profiles.

The FTSE 100 pharmaceuticals giant said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) endorsed Imfinzi in combination with chemotherapy as a first-line treatment, followed by Lynparza and Imfinzi for patients with mismatch repair proficient (pMMR) disease.

Additionally, Imfinzi combined with chemotherapy followed by Imfinzi alone was recommended for patients with mismatch repair deficient (dMMR) disease.

The positive opinion was based on the results of the ‘DUO-E’ phase three trial, which demonstrated significant improvements in progression-free survival compared to chemotherapy alone.

Specifically, for pMMR patients, the combination of Lynparza and Imfinzi reduced the risk of disease progression or death by 43%, achieving a median progression-free survival of 15.0 months versus 9.7 months in the control arm.

For dMMR patients, Imfinzi alone reduced the risk of progression or death by 58%, with the median not reached in the trial against 7.0 months for the control group.

Endometrial cancer, the fourth most common cancer among women in Europe, saw nearly 125,000 new cases and over 30,000 deaths in 2022.

Early-stage diagnosis had a high five-year survival rate of 80% to 90%, but that dropped to below 20% for advanced cases.

The significant proportion of patients with pMMR disease - 70% to 80% - highlighted the urgent need for new treatment options.

AstraZeneca also noted that the recommendation also emphasised the importance of MMR testing at diagnosis, which was widely available and established.

Both treatment regimens' safety profiles were found to be manageable and consistent with the known profiles of Imfinzi and Lynparza.

Regulatory reviews for the treatments were also underway in Japan and other countries, following the DUO-E trial outcomes.

In the United States, Imfinzi plus chemotherapy was already approved for dMMR patients with primary advanced or recurrent endometrial cancer.

“Today's recommendation for approval in the EU recognises the potential of the Lynparza and Imfinzi combination to provide clinical benefit for patients with endometrial cancer, especially for those with mismatch repair proficient disease who have few available treatments today,” said Susan Galbraith, executive vice-president of oncology research and development.

“If approved, patients in Europe will have a new option for combination treatment that brings the additional benefit of PARP inhibition to immunotherapy.”

At 0818 BST, shares in AstraZeneca were down 0.21% at 12,330p.

Reporting by Josh White for Sharecast.com.