Imfinzi, Lynparza combo approved in EU for mismatch repair proficient advanced or recurrent endometrial cancer: AstraZeneca

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on a prespecified exploratory subgroup analysis by mismatch repair (MMR) status from the DUO-E Phase III trial, which was published in the Journal of Clinical Oncology.

In the trial, the Lynparza and Imfinzi regimen reduced the risk of disease progression or death for patients with pMMR disease by 43% (median 15.0 months versus 9.7 months, hazard ratio [HR] 0.57; 95% confidence interval [CI] 0.44-0.73) versus the control arm. The Imfinzi regimen reduced the risk of disease progression or death among patients with dMMR disease by 58% (median not reached versus 7.0 months, HR 0.42; 95% CI 0.22-0.80) versus the control arm.

Els Van Nieuwenhuysen, Gynaecological Oncologist at the UZ Leuven, Belgium and DUO-E trial investigator, said, “This approval is welcome news for patients with advanced or recurrent endometrial cancer in Europe, especially those with mismatch repair proficient disease who have limited options. The olaparib and durvalumab as well as the durvalumab regimens now have the potential to improve outcomes for all patients in this setting in Europe, regardless of mismatch repair status.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said, “This approval of Imfinzi and Lynparza regimens marks the first-ever approval for a combination of an immunotherapy and PARP inhibitor in endometrial cancer and a major step forward for patients. In Europe, endometrial cancer is the fourth most common cancer in women, and until now, the 70 to 80 per cent of patients who have mismatch repair proficient disease have had few available treatment options.”

The safety profiles of both regimens were generally manageable, well-tolerated and broadly consistent with the known profiles of the individual agents.

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.

Read also: AstraZeneca Imfinzi gets USFDA priority review for limited-stage small cell lung cancer