Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non-Small Cell Lung Cancer

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Adjuvant osimertinib is standard for resected EGFR-mutated NSCLC.
• Neoadjuvant treatment may enhance surgical and long-term outcomes.

Purpose of the Study:

• To evaluate the efficacy of neoadjuvant osimertinib, alone or with chemotherapy, versus placebo plus chemotherapy in resectable EGFR-mutated NSCLC.

Main Methods:

• Phase III randomized controlled trial involving 358 patients with resectable, EGFR-mutated, stage II-IIIB NSCLC.
• Patients received neoadjuvant osimertinib plus chemotherapy, osimertinib monotherapy, or placebo plus chemotherapy for ≥9 weeks before surgery.
• Primary endpoint was major pathologic response (MPR); secondary endpoint was event-free survival (EFS).

Main Results:

• Neoadjuvant osimertinib plus chemotherapy (26% MPR) and osimertinib monotherapy (25% MPR) showed significant MPR improvement versus placebo plus chemotherapy (2%).
• 12-month EFS rates were 93% (osimertinib + chemo), 95% (osimertinib alone), and 83% (placebo + chemo).
• Grade ≥3 adverse events occurred in 36% (osimertinib + chemo), 13% (osimertinib alone), and 33% (placebo + chemo); no new safety concerns emerged.

Conclusions:

• Neoadjuvant osimertinib, with or without chemotherapy, significantly improves MPR rates in resectable EGFR-mutated NSCLC.
• This strategy represents a potential advancement over current standard care for this patient population.