Aumolertinib Combination Therapy Shows Promise in Non-Small Cell Lung Cancer Treatment

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Researchers presented new findings from the ACROSS 2 Phase III trial at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC), demonstrating that aumolertinib combined with platinum-pemetrexed chemotherapy significantly improves progression-free survival compared to aumolertinib monotherapy in patients with advanced/metastatic non-small cell lung cancer (NSCLC) harboring EGFR sensitizing mutations and concomitant tumor suppressor gene mutations.

Key Takeaways:

  • The ACROSS 2 trial is the first global, multicenter, open-label, randomized, controlled Phase III trial to investigate the efficacy of EGFR-TKI combined with chemotherapy in patients with EGFR concomitant mutations.
  • Aumolertinib, an oral, third-generation EGFR-TKI, has shown a statistically significant progression-free survival benefit when combined with platinum-pemetrexed chemotherapy compared to monotherapy in patients with EGFR-sensitizing mutations and concomitant tumor suppressor gene mutations.
  • Patients with EGFR concomitant mutations face a poor prognosis and, until now, have had no standard treatment regimen in clinical practice.
  • The combination of aumolertinib and platinum-pemetrexed chemotherapy did not alter aumolertinib's safety profile, and no new safety signals were observed.
  • The most common treatment-emergent adverse events (20%) included decreased white blood cell count, decreased neutrophil count, decreased platelet count, anemia, AST/ALT increase, CK increase, increased serum creatinine, nausea, constipation, and rash.
  • Dr. Jie Wang, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital in China, presented the results, stating that "This Phase III trial provides the first evidence that aumolertinib combined with platinum-pemetrexed offers a statistically significant PFS benefit over monotherapy for this patient population, with a manageable safety profile."

Statistics:

  • Median follow-up: 25.3 months
  • Median progression-free survival (PFS) for combination therapy: 19.78 months vs. 16.53 months for monotherapy; Hazard Ratio (HR) = 0.55 (95% CI: 0.339-0.910; p=0.0205)
  • Baseline characteristics were well balanced between treatment arms
  • Overall survival (OS) data remain immature

Sources:

  • International Association for the Study of Lung Cancer (IASLC)
  • Journal of Thoracic Oncology
  • WCLC (World Conference on Lung Cancer)
  • NCT04500717 (ACROSS 2 trial)
  • NewsRx LLC