Dr Shu on Advances in Adjuvant Therapy For Early-Stage NSCLC

Catherine Shu, MD, medical oncologist, clinical director, Thoracic Medical Oncology Service, Price Family Associate Professor of Medicine, Columbia University Herbert Irving Comprehensive Cancer Center, discusses key therapeutic advances in the adjuvant setting for patients with early-stage non–small cell lung cancer (NSCLC).

The FDA approval of adjuvant osimertinib in 2020was a key therapeutic development for patients with resected NSCLC whose tumors express EGFR exon 19 deletions or exon 21 L858R mutations, Shu begins. The agent's approval was supported by findings from the phase 3 ADAURA trial (NCT02511106), in which adjuvant osimertinib met the trial's primary end point of improved disease-free survival (DFS), she adds.

Mature overall survival (OS) data were subsequently presented at the 2023 ASCO Annual Meeting, and solidified its significance as a new standard of care, Shu continues. The OS hazard ratio in the overall population was 0.49 (95.03% CI, 0.34-0.70; P < .0001) for all patients with stage IB, II, or IIIA NSCLC. The 5-year OS rate in patients with stage II/IIIA disease given osimertinib was 88% (95% CI, 83%-91%) vs 78% with placebo (95% CI, 73%-82%). Overall, these positive outcomes have positioned adjuvant osimertinib as a key therapeutic option in clinical practice, Shu emphasizes.

Similar research efforts are underway in early-stage, ALK-rearranged lung cancers with the TKI alectinib (Alecensa), Shu adds. Encouraging results from the phase 3 ALINA trial (NCT03456076) demonstrated significantly improved disease-free survival with adjuvant alectinib compared to platinum-based chemotherapy in this population, Shu reports. The promising disease-free survival curves, presented at ESMO, may support the agent's FDA approved in the adjuvant setting, thereby shifting the treatment paradigm for ALK-mutated NSCLC, she says.

These advancements highlight the evolving landscape of adjuvant therapies in NSCLC, which include options targeting distinct molecular profiles in NSCLC, Shu concludes.