Osimertinib Demonstrates a Manageable Safety Profile Among Patients With NSCLC After Definitive CRT
Key Takeaways:
- The phase 3 LAURA study randomly delivered osimertinib to patients with non–small cell lung cancer (NSCLC) to compare the survival and safety outcomes against a placebo.
- Patients receiving osimertinib had slightly more serious adverse events (AEs) than patients receiving the placebo. AEs resulted in more treatment interruptions in the osimertinib group than the placebo group (56% vs 25%).
- The osimertinib group had higher rates of radiation pneumonitis (RP), but these events were mostly low grade and were effectively managed with protocol-mandated toxicity management guidelines.
The phase 3 LAURA clinical trial studied the efficacy and safety outcomes of osimertinib on patients with unresectable stage III epidermal growth factor receptor (EGFR)-mutated NSCLC.
In the study, 216 patients with NSCLC without disease progression after undergoing definitive chemoradiotherapy (CRT) were randomized to receive either osimertinib or a placebo. After definitive CRT, 143 patients received osimertinib and 73 received a placebo.
Osimertinib and AEs
Researchers recorded the AEs patients experienced during the study. The AEs were categorized into 2 groups: RP and interstitial lung disease (ILD).
Serious AEs (AEs of a grade 3 or higher) occurred in 18 patients with osimertinib and 13 patients with the placebo. The most common AEs were diarrhea and paronychia.
RP occurred more frequently in the osimertinib group than the placebo group (48% vs 38%). These AEs were mostly low-grade events and occurred within 18 weeks of treatment.
RP was managed using protocol-mandated toxicity management guidelines. Among the osimertinib patients who experienced RP, 87% continued with treatment, of which 93% had no reoccurrence.
ILD incidences were mostly low-grade events as well and occurred within 20 weeks of treatment.
In the osimertinib group, 56% of patients experienced treatment interruptions due to AEs. Treatment interruptions occurred in 25% of patients receiving the placebo. Additionally, discontinuation of treatment occurred in 13% of osimertinib patients and 5% of placebo patients.
Osimertinib as a Potential Treatment Option for NSCLC
The LAURA study demonstrated osimertinib’s significant survival benefit and manageable safety profile in treating patients with NSCLC.
According to the researchers, “Osimertinib after definitive CRT had an acceptable and manageable safety/tolerability profile, with no new safety findings, supporting osimertinib as the new standard of care in this setting.”
Reference
Kato T, Dong X, Takahashi T, et al. Osimertinib after definitive CRT in unresectable stage III EGFR-mutated NSCLC: safety outcomes from the phase III LAURA study. Lung Cancer. 2026; 218:109486. doi:10.1016/j.lungcan.2026.109486
