Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA 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.
Efficacy was evaluated in ADRIATIC (ClinicalTrials.gov. Identifier: NCT03703297), a randomized, double-blind, placebo-controlled trial in 730 patients with LS-SCLC whose disease had not progressed after concurrent platinum-based chemotherapy and radiation therapy. Patients were randomized 1:1:1 to receive durvalumab as a single agent, durvalumab in combination with tremelimumab (Imjudo, AstraZeneca), or placebo.
The major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) assessed by blinded independent central review for the comparison between durvalumab as a single agent and placebo. Durvalumab demonstrated a statistically significant OS improvement compared with placebo, with a hazard ratio (HR) of 0.73 (95% CI, 0.57-0.93; P=0.0104). The median OS was 55.9 months (95% CI, 37.3 months to not reached) in the durvalumab arm and 33.4 months (95% CI, 25.5-39.9 months) in the placebo arm. Durvalumab also demonstrated a statistically significant PFS improvement compared with placebo, with an HR of 0.76 (95% CI, 0.61-0.95; P=0.0161). The median PFS was 16.6 months (95% CI, 10.2-28.2 months) and 9.2 months (95% CI, 7.4-12.9 months) in the durvalumab and placebo arms, respectively.
The most common adverse reactions (≥20%) with durvalumab were pneumonitis or radiation pneumonitis and fatigue.
The full prescribing information for Imfinzi is posted here.
Based on a press release from the FDA.
