^
    1m
    Associations between dynamic hematological indicators and outcomes in HR-positive, HER2-negative metastatic breast cancer treated with bireociclib or placebo plus fulvestrant: Findings from the BRIGHT-2 trial. (PubMed, Breast)
    Peripheral blood-derived indicators are prognostic markers for HR-positive, HER2-negative metastatic breast cancer. Elevated PLR during treatment indicates poor response to CDK4/6 inhibitors.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • Xuan Yue Ning (bireociclib)
    2ms
    Safety and tolerability of bireociclib for the treatment of advanced solid tumors as monotherapy and in combination with endocrine therapy: a multicenter, open-label, phase 1 clinical trial. (PubMed, BMC Med)
    Bireociclib demonstrated favorable efficacy and an acceptable safety profile both as monotherapy (RP2D-S of 480 mg BID) and in combination therapy (RP2D-C of 360 mg BID) for treating HR+/HER2- ABC patients.
    P1 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • Xuan Yue Ning (bireociclib)
    7ms
    Development and validation of an LC-MS/MS method for simultaneous determination of XZP-3287(bireociclib) and its metabolites in human plasma, and its clinical pharmacokinetics application. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci)
    In conclusion, a method for the simultaneous detection of the pharmacokinetic profiles of XZP-3287 and its metabolites in human plasma had been successfully developed. The results demonstrated the efficacy, sensitivity, and reliability of this method.
    PK/PD data • Journal
    |
    CDK4 (Cyclin-dependent kinase 4)
    |
    Xuan Yue Ning (bireociclib)
    8ms
    A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=397, Active, not recruiting, Xuanzhu Biopharmaceutical Co., Ltd. | Not yet recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Sep 2030 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    letrozole • anastrozole • Xuan Yue Ning (bireociclib)
    8ms
    Bireociclib plus fulvestrant for HR+/HER2- advanced female breast cancer progressed on or after endocrine therapy: phase 3 BRIGHT-2 study interim analysis. (PubMed, Nat Commun)
    Grade ≥3 adverse events were more frequent in the BF group (64.7%) than in the F group (18.8%), with neutropenia, leukopenia, and anemia being the most common. These findings suggest that BF is a promising therapeutic option for patients with HR+/HER2- ABC following ET failure.
    Clinical • P3 data • P3 data: top line • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Xuan Yue Ning (bireociclib)
    9ms
    An open-label, single-arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR-positive, HER2-negative advanced breast cancer patients: BRIGHT-1 trial. (PubMed, Cancer Commun (Lond))
    Bireociclib monotherapy at 480 mg BID exhibited promising and sustained clinical activity, with no unexpected and acceptable toxicity in patients with recurrent or metastatic HR+/HER2- breast cancer who had progressed on or after previous therapy.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Xuan Yue Ning (bireociclib)
    1year
    A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors (clinicaltrials.gov)
    P1/2, N=402, Active, not recruiting, Sihuan Pharmaceutical Holdings Group Ltd. | Recruiting --> Active, not recruiting | N=300 --> 402 | Trial completion date: Dec 2022 --> Dec 2025
    Enrollment closed • Enrollment change • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • letrozole • anastrozole • Xuan Yue Ning (bireociclib)
    over1year
    BRIGHT-2: A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=300, Active, not recruiting, Xuanzhu Biopharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    fulvestrant • Xuan Yue Ning (bireociclib)
    over2years
    A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer (ESMO 2023)
    The main results are shown in the table. Table: 404P Responses according to RECIST v1.1 Conclusions In patients with refractory HR+/HER2- MBC who have previously received chemotherapy and endocrine therapy, continuous dosing of single-agent birociclib exhibited promising and sustaining clinical activity with manageable toxicities, thus it provides an alternative orally single-agent therapy.
    Clinical • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Xuan Yue Ning (bireociclib)
    over2years
    A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. (ASCO 2023)
    In patients who have limited treatment options with refractory HR+/HER2- metastatic breast cancer, continuous dosing of single-agent Birociclib exhibited promising and sustaining clinical activity with acceptable safety profile, thus it provided an alternative orally administered therapy option. Clinical trial information: NCT04539496.
    Clinical • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Xuan Yue Ning (bireociclib)
    almost4years
    A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=372, Not yet recruiting, Xuanzhu Biopharmaceutical Co., Ltd.
    New P3 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    letrozole • anastrozole • Xuan Yue Ning (bireociclib)
    almost4years
    A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=300, Recruiting, Xuanzhu Biopharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Xuan Yue Ning (bireociclib)