Osimertinib with or without savolitinib as first-line treatment for MET‑aberrant, EGFR‑mutant NSCLC: randomized phase 2 trial (FLOWERS)

Rákkutatás · NSCLC · osimertinib

The pre‑specified study endpoint was achieved.

The study evaluated the efficacy and safety of osimertinib alone versus osimertinib plus savolitinib as first‑line treatment in patients with advanced non‑small cell lung cancer (NSCLC) harboring EGFR mutations and de‑novo MET aberrations (amplification or overexpression). In this randomized, multicenter, open‑label, phase 2 trial (NCT05163249), 44 treatment‑naïve patients were allocated to either osimertinib monotherapy (80 mg QD) or combination therapy (osimertinib 80 mg QD plus savolitinib 300 mg BID). The primary endpoint was confirmed objective response rate (ORR). The confirmed ORR was 60.9 % (95 % CI 38.5‑80.3) in the osimertinib cohort and 90.5 % (95 % CI 69.6‑98.8) in the combination cohort. Disease‑control rates were 87.0 % versus 95.2 %, respectively. Treatment‑related adverse events of grade 3 or higher occurred in 8.7 % of the monotherapy arm and 57.1 % of the combination arm. The study demonstrated a superior ORR for the dual‑target regimen with an acceptable safety profile.

This result shows that adding the MET‑targeted inhibitor savolitinib to first‑line osimertinib yields a higher treatment response in patients with EGFR‑mutant NSCLC who also carry de‑novo MET alterations, supporting dual‑target therapy as a potentially more effective first‑line strategy for this precision‑defined subgroup.

Bizonyítékszint: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.

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