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Association details:
| Biomarker: | EGFR T790M |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | limertinib (ASK120067) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer
Excerpt:
...- Documented evidence of definitely EGFR T790M+ state in the tumor tissue after disease progression on the most recent treatment regimen (irrespective of whether this is EGFR TKI or chemotherapy)...
Source:
Title:
Efficacy and safety of ASK120067 (limertinib) in patients with locally advanced or metastatic EGFR T790M-mutated non–small cell lung cancer: A multicenter, single-arm, phase IIb study.
Published date:
05/26/2022
Excerpt:
For 99 patients with CNS metastases, the ORR was 64.6% (95%CI 54.4%-74.0%), median PFS was 9.7 (95%CI 5.9-11.6) months, and median DOR was 9.6 (95%CI 8.1-15.2) months. For 41 patients who had evaluable CNS lesion, the confirmed CNS-ORR was 56.1% (95%CI, 39.7%-71.5%) and median CNS-PFS was 10.6 (95%CI 5.6-NE) months....ASK120067 demonstrated promising efficacy and an acceptable safety profile for the treatment of patients with locally advanced or metastatic EGFR T790M mutated NSCLC.
DOI:
10.1200/JCO.2022.40.16_suppl.9106
Trial ID:
Source:
Title:
Efficacy and safety of Limertinib (ASK120067) in patients with locally advanced or metastatic EGFR T790M mutated non-small cell lung cancer: a multicenter, single-arm, phase 2b study
Published date:
05/12/2022
Excerpt:
The median PFS was 11.0 months (95%CI 9.7-12.4), median DoR was 11.1 months (95%CI 9.6-13.8)….Objective responses were achieved across all pre-specified subgroups. For 99 (32.9%) patients with central nervous system (CNS) metastases, the ORR was 64.6% (95%CI 54.4%-74.0%), median PFS was 9.7 months (95%CI 5.9-11.6), and median DoR was 9.6 months (95%CI 8.1-15.2). For 41 patients who had evaluable CNS lesion, the confirmed CNS-ORR was 56.1% (95%CI 39.7%-71.5%) and median CNS-PFS was 10.6 months (95%CI 5.6-NE)....ASK120067 demonstrated promising efficacy and an acceptable safety profile for the treatment of patients with locally advanced or metastatic EGFR T790M mutated NSCLC.
DOI:
10.1016/j.jtho.2022.05.011
Trial ID:
Source:
Title:
CNS Efficacy of AST2818 in Patients with T790M-Positive Advanced NSCLC: Data from a Phase I-II Dose-Expansion Study
Published date:
01/12/2021
Excerpt:
AST2818 demonstrated clinically meaningful efficacy against CNS metastases. 160 mg provided relevant benefit with a high CNS ORR and PFS.
Trial ID:
Source:
Title:
Efficacy and safety of alflutinib (AST2818) in patients with T790M mutation-positive NSCLC: A phase IIb multicenter single-arm study.
Published date:
05/13/2020
Excerpt:
All patients had EGFR T790M mutation….the ORR was 73.6% (95% CI 67.3–79.3). The DCR estimated at 6 and 12 weeks were 87.3% (95%CI 82.1-91.4) and 82.3% (95%CI 76.6-87.1), respectively….Alflutinib has promising efficacy and acceptable safety profile for the treatment of EGFR T790M mutated NSCLC patients.
DOI:
10.1200/JCO.2020.38.15_suppl.9602
Trial ID:
