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    Association details:
    Biomarker:PIK3CA E545A
    Cancer:Ovarian Cancer
    Drug:risovalisib (CYH33) (PIK3CA inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    Nat Commun
    Title:

    First-in-human phase Ia study of the PI3Kα inhibitor CYH33 in patients with solid tumors

    Published date:
    11/16/2022
    Excerpt:
    One patient with ovarian cancer (PIK3CA E545A mutation) who had received 2 lines of previous chemotherapy achieved PR after 5.3 weeks of treatment at the 40 mg dose level and a CR after 29.3 weeks per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the DoR was 15.2 months.
    DOI:
    10.1038/s41467-022-34782-9
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    Ann Oncol
    Title:

    33O A phase I study to evaluate safety, pharmacokinetics (PK), and preliminary efficacy of CYH33, a phosphatidylinositol 3-kinase a (PI3Ka) inhibitor, in patients (pts) with advanced solid tumours

    Published date:
    03/01/2021
    Excerpt:
    One OC pt (PIK3CA E545A mutation) who had received 2 lines of platinum-based chemotherapy achieved complete response (CR) per RECIST 1.1, and the duration of response had lasted more than 10 months...CYH33 demonstrates a manageable safety profile and linear pharmacokinetic characteristics.
    DOI:
    https://doi.org/10.1016/j.annonc.2021.01.048
    Trial ID:
    NCT03544905