AstraZeneca’s anti-PDL1 antibody Imfinzi (durvalumab) and PARP inhibitor Lynparza (olaparib) have been recommended by the European Medicines Agency’s human medicines committee to treat a subset of endometrial cancer patients.
The Committee for Medicinal Products for Human Use (CHMP) has recommended Imfinzi plus chemotherapy as a first-line treatment, followed by Lynparza and Imfinzi, for use in patients with mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
Imfinzi plus chemotherapy, followed by Imfinzi alone, has also been recommended to treat those with mismatch repair deficient (dMMR) disease.
Endometrial cancer is the fourth most common cancer in women in Europe, with nearly 125,000 diagnoses made in 2022.
Patients diagnosed at an early stage of disease have a five-year survival rate of up to 90%, but this falls to less than 20% for those with advanced disease.
The CHMP’s decision on AZ’s regimens was supported by positive results from the late-stage DUO-E trial.
A pre-specified exploratory subgroup analysis demonstrated a reduction in the risk of disease progression or death for pMMR patients receiving the Lynparza/Imfinzi combination by 43% compared to the control arm, while the Imfinzi-treated dMMR cohort showed a reduction in the risk of disease progression or death by 58% versus control.
The safety profiles of both regimens were manageable, well tolerated and broadly consistent with the known profiles of the individual agents, AZ said.
Susan Galbraith, executive vice president, oncology research and development, AZ, said: “[The] 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 pMMR 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.”
Regulatory submissions for Imfinzi and Lynparza are currently under review in several other countries based on the DUO-E study, the company outlined.
The recommendation comes just two weeks after Imfinzi was approved by the US Food and Drug Administration as part of a combination therapy with carboplatin and paclitaxel, also for adults with dMMR primary advanced or recurrent endometrial cancer.