FDA Approves Presurgical, Postsurgical Imfinzi in Some With NSCLC

The effectiveness of the Imfinzi regimen was evaluated in the phase 3 AEGEAN trial.

The Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) as a presurgical and postsurgical treatment for patients with surgically removable non-small cell lung cancer (NSCLC).

Specifically, patients receive Imfinzi plus platinum-based chemotherapy before surgery, and after surgery they receive Imfinzi alone, according to the alert from the agency. To receive this regimen, patients must have tumors of at least 4 centimeters or larger and/or have node-positive NSCLC with no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

The effectiveness of Imfinzi was evaluated in the phase 3 AEGEAN trial, which randomly assigned 802 patients who were previously untreated and have surgically removable squamous or non-squamous NSCLC. Patients were placed into two treatment groups to receive either Imfinzi or placebo (inactive drug), with a platinum-based chemotherapy every three weeks for up to four cycles of presurgical treatment. This was followed by either Imfinzi alone or placebo every four weeks for up to 12 cycles of postsurgical treatment.

The researchers on the trial measured event-free survival (EFS; time until relapse or disease worsening or spreading) and pathological complete response (pCR; absence of residual cancer in the body). Based on the results, the EFS was not reached in the Imfinzi group, meaning not enough of the patients — on average — experienced a relapse or disease worsening by the time researchers collected data. In the placebo group, the EFS was 25.9 months, the alert stated.

Regarding the pCR rates, researchers established that patients in the Imfinzi group had a pCR rate of 17% and patients in the placebo group were 4.3%. At the time of interim analyses during the study, the researchers could not determine the overall survival (OS; time patients live, regardless of disease worsening or spreading) because it was not formally tested for statistical significance. Of note, the researchers reported that there was “no clear detriment,” the FDA alert said, in terms of the OS.

The most common side effects experienced in at least 20% or more of patients included anemia, nausea, fatigue, constipation, rash and musculoskeletal pain. Researchers also found that of the patients who received presurgical Imfinzi, 1.7% were not able to receive surgery because of side effects. This was compared with 1% of patients who were in the placebo group.

Body weight also affects treatment dosage, according to the alert. For patients who weigh at least 30 kilograms (66 pounds), the recommended dose of presurgical Imfinzi is 1,500 milligrams every three weeks and every four weeks as postsurgical treatment. For patients who weigh less than 30 kilograms, the recommended dose is 20 milligrams per kilogram.

The phase 3 trial began in December 2018 and is expected to be completed in September 2028, its listing on clinicaltrials.gov states.

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