Dr Senan on the FDA Approval of Durvalumab for LS-SCLC

“[Results from the phase 3 ADRIATIC trial] are very significant…because we’ve actually had very little change in the treatment paradigm for the past 30 or so years.”

Suresh Senan, MRCP, FRCR, PhD, full professor, treatment and quality of life, cancer biology and immunology, radiation oncology;professor, clinical experimental radiotherapy, Amsterdam University Medical Centers, discusses the significance of the FDA approval of durvalumab (Imfinzi) for patients with limited-stage small cell lung cancer (LS-SCLC).

On December 4, 2024, the FDA approved durvalumab for the treatment of adult patients with LS-SCLC whose disease has not progressed after concurrent treatment with platinum-based chemotherapy and radiation therapy. This regulatory decision was supported by data from the randomized, double-blind, placebo-controlled phase 3 ADRIATIC trial (NCT03703297). In this trial, treatment with durvalumab led to a statistically significant improvement in overall survival (OS) compared with placebo among patients with LS-SCLC (n = 730; HR, 0.73; 95% CI, 0.57-0.93; P = .0104). The median OS was 55.9 months (95% CI, 37.3-not reached [NR]) with durvalumab vs 33.4 months (95% CI, 25.5-39.9) with placebo. The median progression-free survival was also improved with durvalumab vs placebo, at 16.6 months (95% CI, 10.2-28.2) vs 9.2 months (95% CI, 7.4-12.9), respectively (HR, 0.76; 95% CI, 0.61-0.95; P = .0161).

Prior to this regulatory decision, few changes had been made to the LS-SCLC treatment paradigm over the past several decades, Senan begins. The standard of care (SOC) for patients with this disease has traditionally been concurrent platinum- and etoposide-containing chemoradiotherapy to the chest followed by prophylactic brain irradiation in fit patients, he explains. Furthermore, the 5-year OS rate with this SOC regimen is approximately 30% and over half of patients experience disease recurrence within the first 2 years of treatment, he says. Therefore, durvalumab is a welcome addition to the LS-SCLC treatment armamentarium, Senan concludes.