Efficacy of Aumolertinib (HS-10296) in Patients with Advanced EGFR T790M+ NSCLC: Updated Post NMPA-approval Results from the APOLLO Registrational Trial

J Thorac Oncol. 2021 Nov 18:S1556-0864(21)03323-2. doi: 10.1016/j.jtho.2021.10.024. Online ahead of print.


INTRODUCTION: Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with demonstrated activity against EGFR sensitizing mutations and EGFR T790M mutation.

METHODS: Patients with locally advanced or Metastatic non-small cell lung cancer (NSCLC) who developed an EGFR T790M mutation after progression on first- or second-generation EGFR TKI therapy were enrolled into this registrational phase 2 trial of aumolertinib at 110 mg orally once daily (NCT02981108). The primary endpoint was objective response rate (ORR) by independent central review (ICR).

RESULTS: A total of 244 patients with EGFR T790M-positive NSCLC were enrolled. The ORR by ICR was 68.9% (95% CI: 62.6-74.6). The disease control rate (DCR) was 93.4% (95% CI: 89.6-96.2). The median duration of response (DOR) was 15.1 months (95% CI: 12.5-16.6). The median progression-free survival was12.4 months (95% CI: 9.7-15.0). Among 23 patients with evaluable central nervous system (CNS) metastases, the CNS-ORR and CNS-DCR were 60.9% (95% CI: 38.5-80.3) and 91.3% (95% CI: 72.0-98.9), respectively. The median CNS-DOR was 12.5 months (95% CI: 5.6-NR). Treatment-related adverse events of ≥ grade 3 occurred in 16.4% of patients, with the most common being blood creatine phosphokinase increased (7%) and alanine aminotransferase increased (1.2%). The relative dose density of aumolertinib was 99.2% in this study.

CONCLUSION: Aumolertinib is an effective and well-tolerated third-generation EGFR TKI for patients with EGFR T790M-positive advanced NSCLC after disease progression on first- and second-generation EGFR TKI therapy. Based on these findings, aumolertinib was approved in China for EGFR T790M-positive patients.

PMID:34801749 | DOI:10.1016/j.jtho.2021.10.024

Full Text Link: Read More

Generated by Feedzy