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    1. A Novel Third-generation EGFR Tyrosine Kinase Inhibitor Abivertinib for EGFR T790M-mutant Non–Small Cell Lung Cancer: a Multicenter Phase I/II Study

      [Paper-level Aggregated] PMCID: PMC9365372

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The text indicates that patients with the EGFR T790M mutation showed responses to treatment with abivertinib, suggesting that the presence of this variant can predict treatment efficacy. Oncogenic: The T790M variant is associated with resistance to EGFR inhibitors and is implicated in the progression of non-small cell lung cancer (NSCLC), indicating its role in oncogenesis.

      Gene→Variant (gene-first): EGFR(1956):T790M EGFR(1956):Thr790Met

      Genes: EGFR(1956)

      Variants: T790M Thr790Met

    2. Abivertinib of 300 mg twice a day demonstrated favorable clinical efficacy with manageable side effects in patients with EGFR T790M+ NSCLC.

      [Paragraph-level] PMCID: PMC9365372 Section: ABSTRACT PassageIndex: 9

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage indicates that the variant T790M is associated with favorable clinical efficacy of the therapy Abivertinib in patients, suggesting a correlation with treatment response. Diagnostic: The mention of patients with EGFR T790M+ NSCLC implies that the T790M variant is used to classify or define a specific subtype of non-small cell lung cancer.

      Gene→Variant (gene-first): 1956:T790M

      Genes: 1956

      Variants: T790M

    3. To establish recommended phase II dose (RP2D) in phase I and evaluate safety and efficacy of abivertinib in patients with EGFR Thr790Met point mutation (T790M)-positive(+) non-small cell lung cancer (NSCLC) with disease

      [Paragraph-level] PMCID: PMC9365372 Section: ABSTRACT PassageIndex: 3

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage discusses the evaluation of safety and efficacy of abivertinib in patients with the T790M mutation, indicating a correlation with treatment response in the context of non-small cell lung cancer. Diagnostic: The mention of the Thr790Met point mutation (T790M) being positive in patients with non-small cell lung cancer suggests its role in defining or classifying the disease subtype.

      Gene→Variant (gene-first): 1956:T790M 1956:Thr790Met

      Genes: 1956

      Variants: T790M Thr790Met

    4. The data from safety, efficacy, and PK studies suggest that abivertinib dose levels of 150 to 300 mg twice a day may represent the efficacious range while 350 mg twice a day dose had the least favorable safety profile, t

      [Paragraph-level] PMCID: PMC9365372 Section: RESULTS PassageIndex: 13

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage discusses the overall response rate (ORR) and disease control rate (DCR) in patients with the T790M variant, indicating a correlation with treatment response to abivertinib. Diagnostic: The mention of T790M+ in the context of evaluating patient cohorts suggests that this variant is used to classify or define a specific group of patients for treatment assessment.

      Gene→Variant (gene-first): 1956:T790M

      Genes: 1956

      Variants: T790M

    5. Of the 132 evaluable patients with EGFR T790M+ treated across all dose levels, responses were observed with 100 to 300 mg twice-a-day doses, and with highest ORR in 200 mg twice a day (40.0%, 8/20) and 300 mg twice a day

      [Paragraph-level] PMCID: PMC9365372 Section: RESULTS PassageIndex: 9

      Evidence Type(s): Predictive

      Justification: Predictive: The passage discusses the response rates of patients with the T790M variant treated with specific doses of abivertinib, indicating a correlation between the variant and treatment response.

      Gene→Variant (gene-first): 1956:T790M

      Genes: 1956

      Variants: T790M

    6. A total of 878 Chinese patients with NSCLC were screened (Fig. 1). In phase I, a total of 231 patients were screened and 140 patients who received treatment were included in this analysis; in phase II, 647 patients were

      [Paragraph-level] PMCID: PMC9365372 Section: RESULTS PassageIndex: 3

      Evidence Type(s): Diagnostic, Predictive

      Justification: Diagnostic: The passage indicates that T790M-negative status was a major reason for exclusion from the study, suggesting its role in defining eligibility for treatment in patients with NSCLC. Predictive: The mention of T790M-negative status as a reason for screening failure implies that the presence of this variant may correlate with resistance to the treatment being studied (abivertinib).

      Gene→Variant (gene-first): 1956:T790M

      Genes: 1956

      Variants: T790M

    7. The data from safety, efficacy, and PK studies suggest that abivertinib dose levels of 150 to 300 mg twice a day may represent the efficacious range while 350 mg twice a day dose had the least favorable safety profile, t

      [Paragraph-level] PMCID: PMC9365372 Section: RESULTS PassageIndex: 13

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage discusses the overall response rate (ORR) and disease control rate (DCR) in patients with the T790M variant, indicating a correlation with treatment response to abivertinib. Diagnostic: The mention of T790M+ in the context of evaluating patient cohorts suggests that this variant is used to classify or define a specific group of patients for treatment assessment.

      Gene→Variant (gene-first): 1956:T790M

      Genes: 1956

      Variants: T790M

    8. Of the 132 evaluable patients with EGFR T790M+ treated across all dose levels, responses were observed with 100 to 300 mg twice-a-day doses, and with highest ORR in 200 mg twice a day (40.0%, 8/20) and 300 mg twice a day

      [Paragraph-level] PMCID: PMC9365372 Section: RESULTS PassageIndex: 9

      Evidence Type(s): Predictive

      Justification: Predictive: The passage discusses the response rates of patients with the T790M variant treated with specific doses of abivertinib, indicating a correlation between the variant and treatment response.

      Gene→Variant (gene-first): 1956:T790M

      Genes: 1956

      Variants: T790M

    9. A total of 878 Chinese patients with NSCLC were screened (Fig. 1). In phase I, a total of 231 patients were screened and 140 patients who received treatment were included in this analysis; in phase II, 647 patients were

      [Paragraph-level] PMCID: PMC9365372 Section: RESULTS PassageIndex: 3

      Evidence Type(s): Diagnostic, Predictive

      Justification: Diagnostic: The passage indicates that T790M-negative status was a major reason for exclusion from the study, suggesting its role in defining eligibility for treatment in patients with NSCLC. Predictive: The mention of T790M-negative status as a reason for screening failure implies that the presence of this variant may correlate with resistance to the treatment being studied (abivertinib).

      Gene→Variant (gene-first): 1956:T790M

      Genes: 1956

      Variants: T790M