LONDON (dpa-AFX) - British drug major AstraZeneca Plc (AZN.L, AZN) announced
Monday that Imfinzi (durvalumab) and Lynparza (olaparib) have been recommended
for approval in the European Union or EU as treatment for certain patients with
primary advanced or recurrent endometrial cancer.

The positive opinion by the Committee for Medicinal Products for Human Use or
CHMP of the European Medicines Agency is based on a prespecified exploratory
subgroup analysis by mismatch repair or MMR status from the DUO-E Phase III
trial, which showed both regimens demonstrated statistically significant and
clinically meaningful improvement in progression-free survival vs. chemotherapy
alone.

The company noted that Imfinzi plus chemotherapy as 1st-line treatment followed
by Lynparza and Imfinzi has been recommended for patients with mismatch repair
proficient or pMMR disease. Further, Imfinzi plus chemotherapy followed by
Imfinzi alone has been recommended for patients with mismatch repair deficient
or dMMR disease.

The DUO-E Phase III trial results were published in the Journal of Clinical
Oncology in October 2023.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said,
'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. If approved, patients in Europe will
have a new option for combination treatment that brings the additional benefit
of PARP inhibition to immunotherapy.'

AstraZeneca noted that regulatory submissions for Imfinzi and Lynparza are
currently under review in Japan and several other countries based on the DUO-E
trial.

Imfinzi plus chemotherapy was recently approved for dMMR patients with primary
advanced or recurrent endometrial cancer in the US.

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