AZ: FDA autoriza Imfinzi para "endometrial cancer"

 

AstraZeneca’s (AZ) Imfinzi (durvalumab) has been approved by the US Food and Drug Administration (FDA) as part of a combination therapy for a subset of endometrial cancer patients.

Imfinzi plus carboplatin and paclitaxel, followed by Imfinzi monotherapy, is now authorised to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

The FDA’s decision was supported by positive results from the late-stage DUO-E trial, in which the Imfinzi regimen reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer versus chemotherapy alone.

The safety and tolerability profile of the regimen was generally manageable, well tolerated and broadly consistent with prior clinical trials, AZ said.

Endometrial cancer is the sixth most common cancer in women globally and dMMR disease accounts for up to 30% of all cases.

Patients diagnosed at an early stage of disease have a five-year survival rate of up to 90%, but AZ outlined that there remains a “significant need” for new treatment options for those with advanced disease, where the survival rate falls to less than 20%.

Imfinzi, which already holds approvals in lung cancer, biliary tract cancer and hepatocellular carcinoma, is a human monoclonal antibody designed to block the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Commenting on the latest authorisation for the drug, Dave Fredrickson, executive vice president, oncology business unit, AZ, said: “There have been limited advances in the treatment of endometrial cancer in the last few decades, and continued innovation is critical as the burden of this cancer is expected to grow in the future.

“Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this setting and the approval of Imfinzi offers an important new option for patients with dMMR disease.”

DUO-E has also been evaluating Imfinzi plus chemotherapy, followed by Imfinzi plus Lynparza (olaparib), as a maintenance therapy. Regulatory applications for both Imfinzi and Imfinzi/Lynparza regimens are currently under review in the EU and several other countries based on results from the study.

Ver