Durvalumab Approved for Limited-Stage Small Cell Lung Cancer
Expert Perspectives · Lyn Brook · 2024-12-05
The FDA has granted approval to durvalumab (Imfinzi®, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
Why Is the Approval of Durvalumab Important?
“Adjuvant therapy with durvalumab, with or without tremelimumab, may have efficacy in patients with limited-stage small-cell lung cancer who do not have disease progression after standard concurrent platinum-based chemoradiotherapy,” wrote Ying Cheng, MD, and colleagues, in their published results of the ADRIATIC trial (NCT03703297), on which approval was based.
Investigating Durvalumab in ADRIATIC
Efficacy was measured in the phase 3, double-blind, placebo-controlled trial which enrolled 730 patients with LS-SCLC whose disease had not progressed following concurrent platinum-based chemotherapy and radiation therapy. Patients were randomized 1:1:1 to receive either single-agent durvalumab, durvalumab plus tremelimumab, or placebo.
The primary end points measured were overall survival and progression-free survival as assessed by Blinded Independent Central Review (BICR) for the comparison between single-agent durvalumab and placebo.
At the time of analysis, durvalumab had shown a statistically significant improvement in overall survival compared with placebo. The median overall survival was 55.9 months in those receiving durvalumab compared with 33.4 months in those receiving placebo. In addition, progression-free survival also saw a statistically significant improvement in the durvalumab arm compared with placebo. The median progression-free survival was 16.6 months in the durvalumab arm and 9.2 months in the placebo arm.
Adverse Events
The most common adverse events experienced in ≥20% of those receiving durvalumab were pneumonitis or radiation pneumonitis and fatigue.
Putting It Into Context
“Adjuvant therapy with durvalumab led to significantly longer overall survival and progression-free survival than placebo among patients with limited-stage small-cell lung cancer,” concluded Dr. Cheng and colleagues.
Dosing Instructions
The recommended dosage of durvalumab is based on body weight and should be administered until disease progression or unacceptable toxicity or a maximum of 24 months:
- 1,500 mg every four weeks for patients with a body weight of ≥30 kg
- 20 mg/kg every four weeks for patients with a body weight of <30 kg