Introduction
The U.S. Food and Drug Administration (FDA) recently approved the use of durvalumab (Imfinzi, AstraZeneca) in combination with platinum-based chemotherapy as a neoadjuvant treatment for adults with resectable non-small cell lung cancer (NSCLC). This treatment regimen is followed by durvalumab monotherapy as adjuvant therapy post-surgery. This approval is specifically for patients with tumors measuring ≥ 4 cm or those with node-positive disease, provided there are no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
Drug Details and Technology
Durvalumab is an immune checkpoint inhibitor targeting PD-L1, enhancing the body’s immune response against cancer cells. The approved regimen involves a combination of durvalumab with platinum-based chemotherapy administered every three weeks for up to four cycles as neoadjuvant therapy. Post-surgery, patients continue with durvalumab monotherapy every four weeks for up to twelve cycles.
Trial Details
The efficacy of durvalumab was evaluated in the AEGEAN trial (NCT03800134), a randomized, double-blind, placebo-controlled, multicenter study involving 802 patients with previously untreated, resectable NSCLC (Stage IIA to select Stage IIIB). Patients were randomized to receive either durvalumab or placebo alongside platinum-based chemotherapy. The primary endpoints included event-free survival (EFS) and pathological complete response (pCR).
Efficacy and Safety Outcomes
The trial demonstrated a median EFS that was not reached in the durvalumab arm, compared to 25.9 months in the placebo arm, with a hazard ratio of 0.68, indicating a significant improvement in favor of durvalumab. The pCR rate was also higher in the durvalumab arm at 17%, compared to 4.3% in the placebo group. The most common adverse reactions reported were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. Importantly, 1.7% of patients receiving neoadjuvant durvalumab were unable to undergo surgery due to adverse reactions, compared to 1% in the placebo arm.
Dosage and Administration
For patients weighing 30 kg or more, the recommended durvalumab dosage is 1,500 mg every three weeks during neoadjuvant treatment, followed by the same dosage every four weeks as adjuvant treatment. For those under 30 kg, the dosage is 20 mg/kg. It is recommended that durvalumab be administered before chemotherapy when both are given on the same day.
Conclusion
The approval of durvalumab for neoadjuvant and adjuvant use in resectable NSCLC marks a significant advancement in lung cancer treatment, offering a new option that could improve survival outcomes for patients with this challenging disease. As more data emerges, durvalumab’s role in the management of resectable NSCLC is likely to expand, providing hope for better patient outcomes.
Dr. Vinoth Khandelwal, Ph.D.
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