Dr Ramalingam on Osimertinib Post-Chemoradiotherapy in Unresectable, Stage III, EGFR-Mutated NSCLC

Suresh S. Ramalingam, MD, FACP, FASCO, professor, Department of Hematology and Medical Oncology, Roberto C. Goizueta Distinguished Chair for Cancer Research, Emory University School of Medicine, executive director, Winship Cancer Institute of Emory University, associate vice president, cancer, Woodruff Health Sciences Center, discusses primary findings from the phase 3 LAURA trial (NCT03521154) investigating the use of osimertinib (Tagrisso) after definitive chemoradiotherapy in patients with unresectable stage III EGFR-mutated non–small cell lung cancer (NSCLC).

Ramalingam begins by noting that investigators enrolled patients with locally advanced NSCLC whose disease harbored EGFR exon 19 deletions or L858R mutations. All patients received definitive chemoradiotherapy before being randomly assigned to osimertinib or placebo, and they were required to have a response or stable disease following chemoradiotherapy, he explains.

Findings presented at the 2024 ASCO Annual Meeting demonstrated that patients treated with osimertinib (n = 143) achieved a median PFS of 39.1 months (95% CI, 31.5–not calculable) vs 5.6 months (95% CI, 3.7-7.4) for patients who received placebo (n = 73; HR, 0.16; 95% CI, 0.10-0.24; P < .001).

The 12- and 24-month PFS rates in the osimertinib arm were 74% and 65%, respectively, as opposed to respective rates of 22% and 13% in the placebo arm.

In terms of safety, Ramalingam explains that the results for osimertinib after chemoradiotherapy aligned with the established safety profile of the EGFR inhibitor, chemotherapy, and radiation, and most toxicities were manageable. He highlights that most adverse effects (AEs) were grade 1 or 2 and did not result in treatment discontinuation.

The most common any-grade AEs reported in at least 10% of patients included radiation pneumonitis (osimertinib, 48%; placebo, 38%), diarrhea (36%; 14%), rash (24%; 14%), COVID-19 (20%; 8%), paronychia (17%; 1%), cough (16%; 10%), decreased appetite (15%; 5%), dry skin (13%; 5%), pruritus (13%; 7%), stomatitis (12%; 3%), decreased white blood cell count (12%; 3%), pneumonia (11%; 8%), anemia (10%; 4%), and musculoskeletal chest pain (3%; 12%).