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    Association details:
    Biomarker:EGFR T790M
    Cancer:Non Small Cell Lung Cancer
    Drug:Fujovee (abivertinib) (EGFR inhibitor, BTK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study to Investigate the Absorption, Metabolism and Excretion of [14C] AC0010 in Patients With Advanced NSCLC

    Excerpt:
    ...- failed to the treatment of EGFR-TKI and harbored T790M mutation...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer

    Excerpt:
    ...For Part 1 only: subjects with a positive T790M mutation are preferred, but...
    Trial ID:
    NCT02448251
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC

    Excerpt:
    ...To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).`...
    Trial ID:
    NCT03300115
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study Comparing AC0010 and Chemotherapy in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI

    Excerpt:
    ...Confirmation of tumor harboring of T790M mutation by central lab with a biopsy sample taken after failure of first generation EGFR TKIs....
    Trial ID:
    NCT03058094
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Preliminary Evaluation of Safety and Efficacy by [14C] AC0010 Trail and Subsequent AC0010 Treatment

    Excerpt:
    ...- failed to the treatment of EGFR-TKI and harbored T790M mutation...
    Trial ID:
    NCT03053219
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010 in Patients With EGFR T790M Positive NSCLC

    Excerpt:
    ...Failed to the treatment of EGFRTKI with definite state of T790M, or harbored T790M mutation without the treatment of EGFRTKI....
    Trial ID:
    NCT02330367
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Sorrento Therapeutics Press Release
    Title:

    Sorrento Announces Significant Positive Pivotal Trial Results as Assessed by an Independent Review Committee (IRC) With Matured Long-Term (Over Three Years) Follow-Up Data of Abivertinib for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

    Published date:
    08/23/2022
    Excerpt:
    Sorrento Therapeutics, Inc...today announced positive results from a pivotal study of Abivertinib on 209 response evaluable, heavily pretreated NSCLC patients by an IRC assessment with matured long-term follow up data.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Cancer Res
    Title:

    A novel third generation EGFR tyrosine kinase inhibitor Abivertinib for EGFR T790M mutant Non-Small Cell Lung Cancer: a multicenter phase1/2 study

    Published date:
    03/15/2022
    Excerpt:
    This multicenter, open-label study included 367 adult Chinese patients. Abivertinib at doses of 50 mg twice a day to 350 mg twice a day was evaluated in phase I in continual 28-day cycles, and the RP2D of 300 mg twice a day was used in phase II in continual 21-day cycles....Abivertinib of 300 mg twice a day demonstrated favorable clinical efficacy with manageable side effects in patients with EGFR T790M+ NSCLC.
    DOI:
    10.1158/1078-0432.CCR-21-2595
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Thorac Cancer
    Title:

    Abivertinib in patients with T790M-positive advanced NSCLC and its subsequent treatment with osimertinib

    Excerpt:
    NSCLC patients with the EGFR T790M mutation were orally administered abivertinib (150-300 mg) twice daily for cycles of 28 continuous days and tumor response was assessed….Median progression-free survival (PFS) was 5.9 months (95% confidence interval (CI): 3.259-8.541) and median overall survival (OS) was 17.9 months (95% CI: 11.36-24.5).
    DOI:
    10.1111/1759-7714.13302
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Lung Cancer
    Title:

    Penetration of the blood–brain barrier by avitinib and its control of intra/extra-cranial disease in non-small cell lung cancer harboring the T790M mutation

    Excerpt:
    Sixteen NSCLC patients were included, of whom nine (60.0%) achieved a partial response, and five (33.3%) achieved stable disease. Median progression-free survival (PFS) and overall survival were 247 days...Avitinib is well tolerated and efficacious in T790M-positive patients.
    DOI:
    https://doi.org/10.1016/j.lungcan.2018.05.010