Officials with the FDA have 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.1
Researchers evaluated efficacy in ADRIATIC (NCT03703297), a double-blind, placebo-controlled trial in which 730 patients with LS-SCLC whose disease had not progressed following concurrent platinum-based chemotherapy and radiation therapy were randomly assigned 1:1:1 to receive durvalumab as a single agent, durvalumab in combination with tremelimumab, or placebo.
Durvalumab demonstrated a statistically significant overall survival (OS) improvement compared with placebo (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.57-0.93; P=.0104). The median OS was 55.9 months (95% CI, 37.3-not reached) in the durvalumab arm and 33.4 months (95% CI, 25.5-39.9) in the placebo arm. Durvalumab also demonstrated a statistically significant progression-free survival (PFS) improvement compared with placebo (HR, 0.76; 95% CI, 0.61-0.95; P=.0161). The median PFS was 16.6 months (95% CI, 10.2-28.2) and 9.2 months (95% CI, 7.4-12.9) in the durvalumab and placebo arms, respectively.
“The ADRIATIC trial showed 57 per cent of patients were still alive at three years after being treated with durvalumab, which underscores the practice-changing potential of this medicine in this setting,” Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and international coordinating investigator in the trial, said in a press release about the approval.2
Adverse reactions reported ≥20% of the time included pneumonitis or radiation pneumonitis and fatigue.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, and Switzerland’s Swissmedic. The European Medicines Agency was an official observer of this review. The application reviews may be ongoing at the other regulatory agencies.
The approval was announced on December 4, 2024.1
References
- FDA approves durvalumab for limited-stage small cell lung cancer. Press release. FDA. Published December 4, 2024. Accessed December 5, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer
- Imfinzi approved in the US as first and only immunotherapy regimen for patients with limited-stage small cell lung cancer. Press release. AstraZeneca. Published December 5, 2024. Accessed December 5, 2024. www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-approved-in-us-for-limited-stage-sclc.html