FDA Approves Osimertinib in Stage III EGFR-Mutated NSCLC

• The FDA approved osimertinib (Tagrisso) for the treatment of patients with stage III EGFR-mutated non–small cell lung cancer (NSCLC) whose disease did not progress during or following concurrent or sequential platinum-based chemoradiation.
• The approval is supported by the phase 3 LAURA trial (NCT03521154).
• Osimertinib led to statistically significant improvements in progression-free survival (PFS).

Osimertinib has gained FDA approval for the treatment of adult patients with locally advanced, unresectable, stage III NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.¹

Data from the phase 3 LAURA trial support this regulatory decision. Findings presented at the 2024 American Society of Clinical Oncology Annual Meeting showed there to be a dramatic improvement in PFS for those taking osimertinib with 39.1 months (95% CI, 31.5-not calculable) vs 5.6 months (95% CI, 3.7-7.4). The 12-month PFS rate was 74% with osimertinib vs 22% with placebo, and the 24-month PFS rates were 65% vs 13%, respectively.²

Overall survival data were not mature at the time of analysis; however, there was no trend toward a detriment observed.

For safety, the most common adverse effects observed in at least 20% of patients included lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.

“It is an exciting time for patients with lung cancer because of the availability of targeted and immunotherapy treatment options. We are seeing improvement in patients with non–small cell lung cancer. Overall, patients with lung cancer are living better and living longer, and that is thanks to the amazing therapeutic advances that have been made in the past few years,” Suresh S. Ramalingam, MD, FACP, FASCO, executive director of the Winship Cancer Institute of Emory University, previously told Targeted Oncology^TM, in an interview.

REFERENCES:

1. FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy. News release. FDA. September 25, 2024. Accessed September 25, 2024. https://tinyurl.com/5n6hvjkn

2. Ramalingam SS, Kato T, Dong X, et al. Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. J Clin Oncol. 2024;42(suppl 17):abstr LBA4. doi:10.1200/JCO.2024.42.17_suppl.LBA4