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  2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov
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    1. karim2001khoury 19 Feb 2026
      Phase I, Open-Label, Dose-Escalation/Dose-Expansion Study of Lifirafenib (BGB-283), an RAF Family Kinase Inhibitor, in Patients With Solid Tumors

      [Paper-level Aggregated] PMCID: PMC7325368

      Evidence Type(s): Oncogenic, Predictive, Prognostic

      Justification: Oncogenic: The presence of B-RAFV600E and K-RAS mutations is associated with specific responses to treatment, indicating their role in tumorigenesis and cancer progression. Predictive: The study evaluates the efficacy of lifirafenib, a B-RAFV600E inhibitor, suggesting that the presence of this mutation can predict response to the treatment. Prognostic: The outcomes of patients with B-RAF and K-RAS mutations, including response rates and duration of response, provide prognostic information regarding their disease course and treatment efficacy.

      Gene→Variant (gene-first): BRAF(673):B-RAFV600E KRAS(3845):G13D

      Genes: BRAF(673) KRAS(3845)

      Variants: B-RAFV600E G13D

      CIViC paper-level aggregated PMC7325368
    2. karim2001khoury 19 Feb 2026
      The maximum tolerated dose was established as 40 mg/d; dose-limiting toxicities included reversible thrombocytopenia and nonhematologic toxicity. Across the entire study, the most common grade >= 3 treatment-emergent adv

      [Paragraph-level] PMCID: PMC7325368 Section: ABSTRACT PassageIndex: 6

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage discusses the response of patients with B-RAFV600E mutations to therapy, indicating a correlation between the variant and treatment outcomes in various cancers. Diagnostic: The mention of B-RAFV600E in the context of specific cancer types suggests its use as a biomarker to classify or define these diseases.

      Gene→Variant (gene-first): 673:B-RAFV600E

      Genes: 673

      Variants: B-RAFV600E

      CIViC paragraph-level PMC7325368 Predictive Diagnostic
    3. karim2001khoury 19 Feb 2026
      Lifirafenib is an investigational, reversible inhibitor of B-RAFV600E, wild-type A-RAF, B-RAF, C-RAF, and EGFR. This first-in-human, phase I, dose-escalation/dose-expansion study evaluated the safety, tolerability, and e

      [Paragraph-level] PMCID: PMC7325368 Section: ABSTRACT PassageIndex: 2

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses lifirafenib as an inhibitor specifically targeting B-RAFV600E, indicating a correlation with response to therapy in patients with B-RAF-mutated tumors. Oncogenic: The mention of B-RAFV600E in the context of mutated solid tumors suggests that this somatic variant contributes to tumor development or progression.

      Gene→Variant (gene-first): 673:B-RAFV600E

      Genes: 673

      Variants: B-RAFV600E

      CIViC paragraph-level PMC7325368 Predictive Oncogenic
    4. karim2001khoury 19 Feb 2026
      Across the entire study, 2 patients with K-RAS mutations (endometrial cancer [20 mg/d] and codon 12-mutated NSCLC [30 mg/d], n = 1 each) had confirmed responses, which resulted in an ORR of 3.4%; 32 patients (54.2%) with

      [Paragraph-level] PMCID: PMC7325368 Section: RESULTS PassageIndex: 11

      Evidence Type(s): Predictive, Diagnostic, Oncogenic

      Justification: Predictive: The passage discusses the confirmed responses and stable disease (SD) in patients with K-RAS mutations, including G13D, indicating a correlation with treatment response. Diagnostic: The mention of K-RAS mutations, including G13D, in the context of specific cancer types (endometrial cancer and NSCLC) suggests its role in classifying or defining these diseases. Oncogenic: The reference to K-RAS mutations, including G13D, contributing to tumor development in specific cancer types supports the classification of this variant as oncogenic.

      Gene→Variant (gene-first): 3845:G13D

      Genes: 3845

      Variants: G13D

      CIViC paragraph-level PMC7325368 Predictive Diagnostic Oncogenic
    5. karim2001khoury 19 Feb 2026
      Patients with B-RAF and K-RAS mutations from both phases had responses (Table 3). Among patients with B-RAF mutations, 8 (15.1%) of 53 achieved PR, including 1 patient with melanoma who received prior RAF inhibitor thera

      [Paragraph-level] PMCID: PMC7325368 Section: RESULTS PassageIndex: 10

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses the responses of patients with B-RAF mutations to therapy, indicating a correlation between the B-RAFV600E variant and treatment response, which is characteristic of predictive evidence. Oncogenic: The B-RAFV600E variant is mentioned in the context of patients with B-RAF-mutated tumors, suggesting its role in tumor development or progression, which aligns with oncogenic evidence.

      Gene→Variant (gene-first): 673:B-RAFV600E

      Genes: 673

      Variants: B-RAFV600E

      CIViC paragraph-level PMC7325368 Predictive Oncogenic
    6. karim2001khoury 19 Feb 2026
      The maximum tolerated dose was established as 40 mg/d; dose-limiting toxicities included reversible thrombocytopenia and nonhematologic toxicity. Across the entire study, the most common grade >= 3 treatment-emergent adv

      [Paragraph-level] PMCID: PMC7325368 Section: ABSTRACT PassageIndex: 6

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage discusses the response of patients with B-RAFV600E mutations to therapy, indicating a correlation between the variant and treatment outcomes in various cancers. Diagnostic: The mention of B-RAFV600E in the context of specific cancer types suggests its use as a biomarker to classify or define these diseases.

      Gene→Variant (gene-first): 673:B-RAFV600E

      Genes: 673

      Variants: B-RAFV600E

      CIViC paragraph-level PMC7325368 Predictive Diagnostic
    7. karim2001khoury 19 Feb 2026
      Lifirafenib is an investigational, reversible inhibitor of B-RAFV600E, wild-type A-RAF, B-RAF, C-RAF, and EGFR. This first-in-human, phase I, dose-escalation/dose-expansion study evaluated the safety, tolerability, and e

      [Paragraph-level] PMCID: PMC7325368 Section: ABSTRACT PassageIndex: 2

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses lifirafenib as an inhibitor specifically targeting B-RAFV600E, indicating a correlation with response to therapy in patients with B-RAF-mutated tumors. Oncogenic: The mention of B-RAFV600E in the context of mutated solid tumors suggests that this somatic variant contributes to tumor development or progression.

      Gene→Variant (gene-first): 673:B-RAFV600E

      Genes: 673

      Variants: B-RAFV600E

      CIViC paragraph-level PMC7325368 Predictive Oncogenic
    8. karim2001khoury 19 Feb 2026
      Across the entire study, 2 patients with K-RAS mutations (endometrial cancer [20 mg/d] and codon 12-mutated NSCLC [30 mg/d], n = 1 each) had confirmed responses, which resulted in an ORR of 3.4%; 32 patients (54.2%) with

      [Paragraph-level] PMCID: PMC7325368 Section: RESULTS PassageIndex: 11

      Evidence Type(s): Predictive, Diagnostic, Oncogenic

      Justification: Predictive: The passage discusses the confirmed responses and stable disease (SD) in patients with K-RAS mutations, including G13D, indicating a correlation with treatment response. Diagnostic: The mention of K-RAS mutations, including G13D, in the context of specific cancer types (endometrial cancer and NSCLC) suggests its role in classifying or defining these diseases. Oncogenic: The reference to K-RAS mutations, including G13D, contributing to tumor development in specific cancer types supports the classification of this variant as oncogenic.

      Gene→Variant (gene-first): 3845:G13D

      Genes: 3845

      Variants: G13D

      CIViC paragraph-level PMC7325368 Predictive Diagnostic Oncogenic
    9. karim2001khoury 19 Feb 2026
      Patients with B-RAF and K-RAS mutations from both phases had responses (Table 3). Among patients with B-RAF mutations, 8 (15.1%) of 53 achieved PR, including 1 patient with melanoma who received prior RAF inhibitor thera

      [Paragraph-level] PMCID: PMC7325368 Section: RESULTS PassageIndex: 10

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses the responses of patients with B-RAF mutations to therapy, indicating a correlation between the B-RAFV600E variant and treatment response, which is characteristic of predictive evidence. Oncogenic: The B-RAFV600E variant is mentioned in the context of patients with B-RAF-mutated tumors, suggesting its role in tumor development or progression, which aligns with oncogenic evidence.

      Gene→Variant (gene-first): 673:B-RAFV600E

      Genes: 673

      Variants: B-RAFV600E

      CIViC paragraph-level PMC7325368 Predictive Oncogenic
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    pmc.ncbi.nlm.nih.gov/articles/PMC7325368/pdf/JCO.19.02654.pdf