FDA Approves Durvalumab / IMFINZI® for Resectable NSCLC Non-Small Cell Lung Cancer

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FDA Approves Durvalumab for NSCLC Treatment in Combination with Chemotherapy

FDA Approves Durvalumab / Imfinzi for Resectable NSCLC Non-Small Cell Lung Cancer

On August 15, 2024, the U.S. Food and Drug Administration (FDA) approved durvalumab (IMFINZI®, AstraZeneca) in combination with platinum-containing chemotherapy for use as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant therapy, in adults with resectable non-small cell lung cancer (NSCLC). This approval applies to patients with tumors measuring 4 cm or greater and/or node-positive disease, excluding those with known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Key Findings from the AEGEAN Trial

The approval was based on efficacy data from the AEGEAN trial (NCT03800134), a randomized, double-blind, placebo-controlled, multicenter trial involving 802 patients with untreated and resectable squamous or non-squamous NSCLC (Stage IIA to selected Stage IIIB). Patients were randomized in a 1:1 ratio to receive durvalumab or placebo, with platinum-based chemotherapy every 3 weeks for up to 4 cycles (neoadjuvant treatment), followed by durvalumab or placebo every 4 weeks for up to 12 cycles (adjuvant treatment) post-surgery.

The major efficacy outcomes were event-free survival (EFS) and pathological complete response (pCR).

Event-Free Survival (EFS): Median EFS was not reached in the durvalumab arm (95% CI: 31.9, not estimable), compared to 25.9 months in the placebo arm (95% CI: 18.9, not estimable) with a hazard ratio of 0.68 (95% CI: 0.53, 0.88), and a p-value of 0.0039.
Pathological Complete Response (pCR): The pCR rate was 17% in the durvalumab arm (95% CI: 13, 21) compared to 4.3% in the placebo arm (95% CI: 2.5, 7).

At the time of interim analysis, overall survival (OS) was not formally tested for statistical significance, although descriptive analysis revealed no detriment.

Dosage and Administration

For patients weighing 30 kg or more, the recommended dosage is 1,500 mg of durvalumab every 3 weeks for neoadjuvant treatment and every 4 weeks for adjuvant treatment. For patients under 30 kg, the recommended dose is 20 mg/kg. Durvalumab should be administered prior to chemotherapy when given on the same day.

Safety Profile

Common adverse reactions reported in the trial (≥20%) included:

Anemia
Nausea
Constipation
Fatigue
Musculoskeletal pain
Rash

Of the patients who received neoadjuvant durvalumab, 1.7% were unable to undergo surgery due to adverse reactions, compared to 1% in the placebo arm.

Reporting Adverse Events

Healthcare professionals are encouraged to report any serious adverse reactions suspected to be associated with the use of durvalumab to the FDA’s MedWatch Reporting System.

For further information on dosing, side effects, and prescribing details, visit the FDA’s full prescribing information for IMFINZI® at Drugs@FDA.

Conclusion

This FDA approval for durvalumab as a neoadjuvant and adjuvant therapy represents a major advancement in the treatment of resectable non-small cell lung cancer. Physicians now have access to a new therapeutic strategy that has shown significant improvements in event-free survival and complete pathological response in patients undergoing surgery for NSCLC.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals can contact the FDA’s Oncology Center of Excellence’s Project Facilitate at 240-402-0004 or via email at OncProjectFacilitate@fda.hhs.gov.