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    DRUG:

    Ostarine (enobosarm)

    i
    Other names: GTx 024, GTx-024, MK-2866, MK 2866, VERU-024, S-22
    Company:
    Veru Inc
    Drug class:
    Selective androgen receptor modulator, Androgen receptor modulator
    Related drugs:
    4ms
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=150, Active, not recruiting, Veru Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Ostarine (enobosarm)
    6ms
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=150, Recruiting, Veru Inc. | N=90 --> 150
    Enrollment change
    |
    Ostarine (enobosarm)
    8ms
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=90, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Ostarine (enobosarm)
    9ms
    Phase II Study of GTx024 in Women With Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=22, Terminated, GTx | Completed --> Terminated
    Trial termination • Metastases
    |
    ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • AR positive
    |
    Ostarine (enobosarm)
    10ms
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Veru Inc.
    New P2 trial
    |
    Ostarine (enobosarm)
    10ms
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=5, Terminated, Veru Inc. | N=186 --> 5
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    10ms
    Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=18, Completed, City of Hope Medical Center | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • ER expression • PGR expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    10ms
    Activity and safety of enobosarm, a novel, oral, selective androgen receptor modulator, in androgen receptor-positive, oestrogen receptor-positive, and HER2-negative advanced breast cancer (Study G200802): a randomised, open-label, multicentre, multinational, parallel design, phase 2 trial. (PubMed, Lancet Oncol)
    Enobosarm has anti-tumour activity in patients with ER-positive, HER2-negative advanced breast cancer, showing that AR activation can result in clinical benefit, supporting further clinical investigation of selective AR activation strategies for the treatment of AR-positive, ER-positive, HER2-negative advanced breast cancer.
    P2 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • AR positive • ER positive + HER-2 negative
    |
    Ostarine (enobosarm)
    11ms
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Suspended, Veru Inc. | Trial completion date: Jan 2024 --> Dec 2025 | Trial primary completion date: Jan 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    11ms
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=52, Terminated, Veru Inc. | N=210 --> 52 | Active, not recruiting --> Terminated; Business decision
    Enrollment change • Trial termination • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    11ms
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Suspended, Veru Inc. | Active, not recruiting --> Suspended | Trial primary completion date: Sep 2023 --> Jan 2024
    Trial suspension • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    1year
    Design of Active Phase 3 ENABLAR-2 Study Evaluating Enobosarm +/- Abemaciclib in Patients with AR+ER+HER2- 2nd-Line Metastatic Breast Cancer Following Tumor Progression on an Estrogen Blocking Agent Plus Palbociclib or Ribociclib (SABCS 2023)
    In the Stage 1 of the study (160 patients), five treatment arms will be assessed with the primary efficacy endpoint of ORR: enobosarm 9 mg QD, enobosarm 1 mg QD + abemaciclib, enobosarm 3 mg QD + abemaciclib, enobosarm 9 mg QD + abemaciclib, and an estrogen blocking agent, active control (a nonsteroidal AI, exemestane +/- everolimus, or SERD). Preliminary data of efficacy and safety of enobosarm in combination with abemaciclib are encouraging. The Phase 3 ENABLAR-2 study is underway to further evaluate enobosarm monotherapy or in abemaciclib combination therapy in 2nd-line metastatic breast cancer population.
    Clinical • P3 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • Ostarine (enobosarm)
    1year
    Clinical Results of Subjects Remaining in the Phase 3 ARTEST Study Enobosarm Therapy in AR+ER+HER2- Metastatic Breast Cancer with 3 or Greater Prior Lines of Therapy (SABCS 2023)
    Activity of enobosarm in this heavily pretreated patient population is encouraging and supports further clinical investigation. The Phase 3 ENABLAR-2 study is underway to further evaluate enobosarm alone or in combination with abemaciclib for the second-line treatment of AR+ER+HER2- metastatic breast cancer in patients who have received a prior estrogen blocking agent and a CDK 4/6 inhibitor. Clinical trial information: NCT04869943.
    Clinical • P3 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • AR positive
    |
    Verzenio (abemaciclib) • Ostarine (enobosarm)
    1year
    Molecular docking analysis of MCL-1 inhibitors for breast cancer management. (PubMed, Bioinformation)
    Visual inspection and binding energy analysis revealed that the compounds OSU-03012, Raltitrexed, Ostarine (MK-2866), Dovitinib (TKI-258), and Varespladib (LY315920) had strong binding affinity for the MCL-1 protein. These findings suggest that these compounds may be useful as MCL-1 inhibitors in the treatment of breast cancer. However, additional experimental validation is required to confirm these findings.
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    dovitinib (TKI258) • Ostarine (enobosarm) • Tomudex (raltitrexed) • AR-12
    1year
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=210, Active, not recruiting, Veru Inc. | Trial completion date: Jul 2023 --> Feb 2024 | Trial primary completion date: Jun 2023 --> Jan 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    1year
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Active, not recruiting, Veru Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    over1year
    Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jan 2023 --> Dec 2023
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • ER expression • PGR expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    over1year
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=210, Active, not recruiting, Veru Inc. | Trial completion date: Apr 2023 --> Jul 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    over1year
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=210, Active, not recruiting, Veru Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    over2years
    Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | N=29 --> 18 | Trial completion date: Nov 2021 --> Jan 2023
    Enrollment change • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • ER expression • PGR expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    over2years
    TiP. Randomized, Multicenter, Phase 3 Study to Evaluate the Combination of Enobosarm and Abemaciclib Compared With Estrogen-Blocking Agent for the Second-Line Treatment of AR+, ER+, HER2– Metastatic Breast Cancer in Patients Who Have Previously Received Palbociclib and an Estrogen-Blocking Agent Combination Therapy (MBCC 2022)
    If first-line therapy for mBC was a nonsteroidal aromatase inhibitor (AI) plus palbociclib (Ibrance), then the patient is randomized to either enobosarm plus abemaciclib (Verzenio) or fulvestrant. Secondary end points include objective response rate, duration of response, overall survival, change from baseline in Short Physical Performance Battery (SPPB), change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ), and change in body composition as measured by dual-energy x-ray absorptiometry (DEXA). Status The study is currently ongoing, and it is anticipated that enrollment will be completed this year.
    Clinical • P3 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • AR positive • AR negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • fulvestrant • Ostarine (enobosarm)
    over2years
    TiP. Randomized, Multicenter, International Phase 3 ARTEST Study to Evaluate the Efficacy and Safety of Enobosarm Versus Active Control for the Treatment of AR+, ER+, HER2– Metastatic Breast Cancer in Patients Who Previously Received an Estrogen-Blocking Agent and CDK4/6 Inhibitor (MBCC 2022)
    Approximately 210 subjects with AR+, ER+, HER2– mBC and with AR nuclei staining of 40% or greater are being randomized 1:1 to either enobosarm 9-mg oral daily dose or an active comparator (either exemestane, everolimus [Afinitor], or a selective estrogen receptor modulator; physician’s choice). The secondary objectives/end points of this study include the objective response rate, duration of response, overall survival, change from baseline in Short Physical Performance Battery (SPPB), and change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ). Status The study is currently ongoing, and it is anticipated that enrollment will be completed this year
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • AR positive • AR expression
    |
    everolimus • exemestane • Ostarine (enobosarm)
    over2years
    Phase 3 ENABLAR-2 study to evaluate enobosarm and abemaciclib combination compared to estrogen-blocking agent for the second-line treatment of AR+, ER+, HER2- metastatic breast cancer in patients who previously received palbociclib and estrogen-blocking agent combination therapy. (ASCO 2022)
    The planned sample size is 186 patients randomized 1:1 to enobosarm + abemaciclib OR fulvestrant if the first line of therapy for MBC was a non-steroidal AI plus palbociclib, until disease progression, toxicity, or loss of clinical benefit. The key objectives are to determine the safety and efficacy of enobosarm and abemaciclib combination versus an alternative estrogen blocking agent with the primary endpoint of PFS. Secondary endpoints include ORR, duration of response, overall survival, change from baseline in Short Physical Performance Battery (SPPB), change in EORTC Quality of Life Questionnaire (EORTC-QLQ) and change in body composition as measured by DEXA.
    Clinical • P3 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • AR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • fulvestrant • Ostarine (enobosarm)
    over2years
    VERU-024: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    almost3years
    ARTEST - A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Enobosarm Monotherapy Versus Active Control for the Treatment of AR+/ER+/HER2- Metastatic Breast Cancer in Patients with Androgen Receptor Nuclei Staining ≥40% Who Have Shown Previous Disease Progression on a Nonsteroidal Aromatase Inhibitor, Fulvestrant and CDK 4/6 inhibitor ARTEST - Estudio aleatorizado de fase III para evaluar la eficacia y la seguridad del enobosarm en monoterapia frente a un control activo para el tratamiento del cáncer de mama metastásico RA+/RE+/HER2- en pacientes con tinción nuclear del receptor de andrógenos ≥40 % que han presentado una progresión previa de la enfermedad con un con un inhibidor de la aromatasa no esteroideo, fulvestrant y un inhibidor de CDK4/6. (clinicaltrialsregister.eu)
    P3, N=210, Ongoing, Veru Inc.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    everolimus • tamoxifen • fulvestrant • exemestane • Ostarine (enobosarm)
    almost3years
    VERU-024: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Not yet recruiting, Veru Inc. | Phase classification: P2 --> P3
    Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    3years
    Randomized, multicenter, international phase 3 ARTEST study to evaluate the efficacy and safety of enobosarm versus active control for the treatment of AR+ ER+ HER2- metastatic breast cancer in patients who progressed on a nonsteroidal aromatase inhibitor, fulvestrant and CDK 4/6 inhibitor (SABCS 2021)
    Approximately, 210 subjects with AR+ ER+ HER2- MBC and with AR nuclei staining ≥40% will be randomized 1:1 to either enobosarm 9mg oral daily dose or an active comparator (either exemestane ± everolimus or selective estrogen receptor modulator; physician’s choice). The secondary objectives/endpoints on this study include the ORR, duration of response, overall survival, and change from baseline in Short Physical Performance Battery (SPPB). The study is planned to begin enrollment in Q3 2021.
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • AR expression
    |
    everolimus • fulvestrant • Ostarine (enobosarm)
    3years
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=210, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • fulvestrant • exemestane • Ostarine (enobosarm)
    3years
    VERU-024: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=186, Not yet recruiting, Veru Inc.
    Clinical • New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    over3years
    Imaging Androgen Receptors in Breast Cancer with F-fluoro-5α-dihydrotestosterone-PET: A Pilot Study. (PubMed, J Nucl Med)
    Seven participants with CB at 12 weeks tended to have larger declines in FDHT uptake compared to those with PD at both 6 (median decline, range: -26.8%, -42.9 to -14.1% vs. -3.7%, -31% to +29%, respectively, p=0.11) and 12 weeks (median decline, range: -35.7%, -69.5 to -7.7% vs. -20.1%, -26.6% to +56.5%, respectively, p=0.17) after starting GTx-024. This hypothesis-generating data suggests that FDHT-PET/CT is worth further study as an imaging biomarker for evaluating response of MBC to SARM therapy and reiterates the feasibility of including molecular imaging in multidisciplinary therapeutic trials.
    Clinical • Journal
    |
    ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • AR expression
    |
    Ostarine (enobosarm)
    over3years
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=210, Not yet recruiting, Veru Inc.
    Clinical • New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • fulvestrant • exemestane • Ostarine (enobosarm)
    over3years
    [VIRTUAL] Efficacy of enobosarm, a selective androgen receptor (AR) targeting agent, correlates with the degree of AR positivity in advanced AR+/estrogen receptor (ER)+ breast cancer in an international phase 2 clinical study. (ASCO 2021)
    Enobosarm is a novel oral selective AR activating agent in which a higher % AR staining correlates with a greater antitumor activity . By targeting and activating AR, enobosarm may represent a new hormone treatment approach for AR+/ER+ MBC . The phase 3, ARTEST trial will commence in early 2021 and randomize patients with AR+/ER+/HER2- heavily treated MBC that have progressed on a non-steroidal aromatase inhibitor, fulvestrant and CDK 4/6 inhibitor to receive enobosarm or standard endocrine therapy.
    Clinical • P2 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • AR expression
    |
    fulvestrant • Ostarine (enobosarm)
    almost4years
    [VIRTUAL] Efficacy of enobosarm, a selective androgen receptor (AR) targeting agent, in patients with metastatic AR+/ER+ breast cancer resistant to estrogen receptor targeted agents and CDK 4/6 inhibitor in a phase II clinical study (ESMO-BC 2021)
    Funding: GTx funded the clinical trial and Veru Inc supported the data analysis.  We report clinical activity of enobosarm in patients with AR+/ER+ MBC with prior disease progression on ER directed therapy plus palbociclib. At the 9 mg dose, which has been selected for the phase III study, the mean rPFS was 10.6 months. These data provide support for exploring the potential clinical benefit of targeting AR with enobosarm in MBC that has progressed on a CDK4/6 inhibitor.
    Clinical • P2 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • Ostarine (enobosarm)
    4years
    Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, City of Hope Medical Center | Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2020 --> Nov 2021
    Clinical • Trial completion date • Trial primary completion date • PD(L)-1 Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • ER expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    4years
    Efficacy and Safety of GTx-024 in Patients With Estrogen Receptor (ER)+/Androgen Receptor (AR)+ Breast Cancer (clinicaltrials.gov)
    P2, N=136, Completed, GTx | Active, not recruiting --> Completed | N=88 --> 136
    Clinical • Trial completion • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    Ostarine (enobosarm)
    4years
    A Phase II Clinical Trial of Pembrolizumab and Enobosarm in Patients with Androgen Receptor-Positive Metastatic Triple-Negative Breast Cancer. (PubMed, Oncologist)
    The combination of enobosarm and pembrolizumab was well tolerated with a modest clinical benefit rate of 25% at 16 weeks in heavily pretreated AR TNBC without pre-selected PD-L1. Future clinical trials combining AR targeted therapy with immune checkpoint inhibitor (ICI) for AR TNBC warrant investigation.
    Clinical • P2 data • Journal • PD(L)-1 Biomarker
    |
    PD-L1 (Programmed death ligand 1) • AR (Androgen receptor)
    |
    AR positive • AR overexpression • AR expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    4years
    Efficacy and Safety of GTx-024 in Patients With Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC) (clinicaltrials.gov)
    P2, N=32, Terminated, GTx | N=55 --> 32
    Clinical • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • PGR negative
    |
    Ostarine (enobosarm)