AstraZeneca (AZ) has announced that its Imfinzi (durvalumab)-based perioperative regimen has been approved by the European Commission (EC) to treat resectable non-small cell lung cancer (NSCLC).
The drug has been authorised for use in combination with neoadjuvant chemotherapy before surgery and then as an adjuvant monotherapy after surgery in adults who are at a high risk of disease recurrence.
Patients eligible for the regimen will also have no epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
More than 450,000 people are diagnosed with lung cancer every year in Europe, with NSCLC accounting for approximately 85% of all cases.
Up to 30% of all patients with NSCLC are diagnosed early enough to have surgery with curative intent, however, the majority of those with resectable disease will develop recurrence.
Imfinzi is designed to attach to, and block the effects of, PD-L1, which is present on the surface of many cancer cells. This increases the ability of the immune system to attack the cancer cells and slows down disease progression.
The drug is already approved in the EU for certain NSCLC indications, including unresectable disease, as well as cancers including biliary tract cancer, hepatocellular carcinoma and endometrial cancer.
The EC’s latest decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by results from the phase 3 AEGEAN trial.
AZ’s regimen achieved a 32% reduction in the risk of recurrence, progression or death compared to neoadjuvant chemotherapy alone, according to a planned interim analysis of event-free survival.
Imfinzi plus neoadjuvant chemotherapy before surgery also resulted in a pathologic complete response rate of 17.2% versus 4.3% for neoadjuvant chemotherapy alone, and interim overall survival results showed a favourable trend with the Imfinzi regimen.
AEGEAN steering committee member and investigator in the trial, Martin Reck, Lung Clinic Grosshansdorf, said: “[This] approval provides an important new treatment option that should become a backbone combination approach for patients in Europe with resectable NSCLC, who have historically faced high rates of recurrence and a poor prognosis.
“When added to neoadjuvant chemotherapy, perioperative [Imfinzi] meaningfully improved outcomes in this curative-intent setting, significantly extending the time patients lived without their cancer returning.”