FDA Approves Durvalumab For Limited-Stage Small Cell Lung Cancer

The US Food and Drug Administration (FDA) has approved 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.

The recommended durvalumab dose is 1,500 mg every four weeks for patients with a body weight of ≥30 kg and 20 mg/kg every four weeks for patients with a body weight of <30 kg until disease progression or unacceptable toxicity or a maximum of 24 months, according to the FDA.

Investigators evaluated the efficacy of durvalumab in the randomized, double-blind, placebo-controlled ADRIATIC trial. The trial included 730 patients with LS-SCLC whose disease had not progressed following concurrent platinum-based chemotherapy and radiation therapy. Study investigators randomized patients 1:1:1 to receive single-agent durvalumab, durvalumab plus tremelimumab, or placebo.

The primary efficacy outcome measures of the ADRIATIC trial were overall survival (OS) and progression-free survival (PFS) to compare single-agent durvalumab and placebo, as assessed by blinded independent central review.

Patients who received durvalumab had a median OS of 55.9 months (95% CI, 37.3 to not reached), significantly higher than the median OS of 33.4 months (95% CI, 25.5 to 39.9) in patients who received placebo (hazard ratio, 0.73; 95% CI, 0.57-0.93; P=.0104). Durvalumab also showed a statistically significant PFS (median PFS, 16.6 months; 95% CI, 10.2-28.2) compared to placebo (median PFS, 9.2 months; 95% CI, 7.4-12.9). The hazard ratio for PFS was 0.76 (95% CI, 0.61-0.95; P=.0161).

The most common adverse reactions, occurring in ≥20%, were pneumonitis or radiation pneumonitis and fatigue, according to the FDA.

Source: FDA