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Jacob Sands, MD, discusses consolidation therapy durvalumab as a new standard of care in limited-stage small cell lung cancer.
Jacob Sands, MD, oncology medical director, International Patient Center, Dana-Farber Cancer Institute; assistant professor, Harvard Medical School, discusses the role of durvalumab (Imfinzi) as consolidation therapy in limited-stage small cell lung cancer (LS-SCLC).
In August 2024, the FDA granted priority review to a supplemental biologics license application seeking the approval of durvalumab for the treatment of patients with LS-SCLC whose disease has not progressed following platinum-based concurrent chemoradiotherapy, based on findings from the phase 3 ADRIATIC trial (NCT03703297).
The ADRIATIC trial evaluated durvalumab vs placebo as a consolidation treatment following chemoradiation therapy in patients with LS-SCLC. Results presented at the 2024 ASCO Annual Meeting demonstrated that at a median follow-up of 37.2 months (range, 0.1-60.9) in censored patients, patients treated with durvalumab (n = 264) experienced a median overall survival (OS) of 55.9 months (95% CI, 37.3–not evaluable) vs 33.4 months (95% CI, 25.5-39.9) for those given placebo (n = 266; HR, 0.73; 95% CI, 0.57-0.93; P = .0104).
Additionally, at a median follow-up of 27.6 months (range, 0.0-55.8), the median progression-free survival (PFS) was 16.6 months (95% CI, 10.2-28.2) with durvalumab vs 9.2 months (95% CI, 7.4-12.9) for placebo (HR, 0.76; 95% CI, 0.61-0.95; P = .0161).
Sands notes that although these results represent a significant improvement in OS, the survival curves looked similar to the patterns seen in previous trials assessing the efficacy of durvalumab, such as the phase 3 PACIFIC (NCT02125461) and CASPIAN (NCT03043872) trials.
Sands emphasizes that the results observed in the ADRIATIC trial have positioned durvalumab as the new standard of care in this setting for patients with LS-SCLC after regulatory agencies review the data to support potential approval.