Found 1 Presentation For Request "1208P"
1208P - Final results of APOLLO study: Overall survival (OS) of aumolertinib in patients with pretreated EGFR T790M-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Shun Lu (Shanghai, China)
Abstract
Background
Aumolertinib is a novel, irreversible third generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). APOLLO, a pivotal phase II single-arm study (NCT02981108), has demonstrated progression-free survival (PFS) benefit with a favorable safety profile in pretreated EGFR T790M positive NSCLC patients.
Methods
Adult pts received aumolertinib 110 mg once daily until disease progression. Treatment beyond progression was allowed if clinical benefit was expected. The primary endpoint was objective response rate by independent central review. Secondary endpoints included PFS, OS and safety. Explore endpoints included the drug resistance mechanism.
Results
At data cutoff (Jul 20, 2021), 126 (51.6%) pts had died among 244 pts. The median follow-up time was 34.5 mo (95%CI 34.0-35.4). The median OS was 30.2 mo (95% CI, 24.2-36.4), and the OS rate at 24 mo was 57.5% (95% CI, 50.8-63.6). OS analyses across pts subgroups was summarized in the table. A total of 82 (33.6%) pts continued aumolertinib treatment beyond disease progression. Forty-two pts had molecular profiling using tumor tissue or blood samples upon first progression on aumolertinib. Seven pts had acquired EGFR C797S in cis with T790M. EGFR L718Q mutation was found in 1 pt. Aberrations in bypass tracks including PIK3CA, JAK2, BRAF and KRAS mutation, HER2 amplification and FGFR3-TACC3 fusion were found in 8 pts. The safety profile of aumolertinib remained consistent with previous data.
Conclusions
Clinical benefit in OS was observed in pts with pretreated EGFR T790M-positive advanced NSCLC receiving aumolertinib. The common mechanisms of resistance to aumolertinib were EGFR C797S mutation and aberrations in bypass tracks.
Clinical trial identification
NCT02981108.
Legal entity responsible for the study
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
Funding
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
Disclosure
S. Lu: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Hansoh; Financial Interests, Institutional, Research Grant: Hengrui Therapeutics; Financial Interests, Institutional, Research Grant: Hutchison MediPharma; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Hansoh; Financial Interests, Institutional, Invited Speaker: Hengrui Therapeutics; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Advisory Role: AstraZeneca; Financial Interests, Institutional, Advisory Role: Boehringer Ingelheim; Financial Interests, Institutional, Advisory Role: GenomiCare; Financial Interests, Institutional, Advisory Role: Hutchison MediPharma; Financial Interests, Institutional, Advisory Role: Menarini; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Advisory Role: prIME Oncology; Financial Interests, Institutional, Advisory Role: Roche; Financial Interests, Institutional, Advisory Role: Simcere; Financial Interests, Institutional, Advisory Role: Yuhan Corporation; Financial Interests, Institutional, Advisory Role: ZaiLab. All other authors have declared no conflicts of interest.