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    DRUG:

    saruparib (AZD5305)

    i
    Other names: AZD5305, AZD-5305, AZD 5305
    Company:
    AstraZeneca
    Drug class:
    PARP1 inhibitor
    Related drugs:
    1d
    EvoPAR-PR02: A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation (clinicaltrials.gov)
    P3, N=700, Recruiting, AstraZeneca
    Trial initiation date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    abiraterone acetate • prednisone • saruparib (AZD5305)
    5d
    Redefining standards: a comprehensive systematic review of practice changing advances in GU oncology from ASCO and ESMO 2025. (PubMed, Front Endocrinol (Lausanne))
    Key advances include: (1) In bladder cancer, perioperative durvalumab (NIAGARA) and enfortumab vedotin plus pembrolizumab (KEYNOTE-905/EV-303) set new standards, while HER2-targeted disitamab vedotin plus toripalimab (RC48-C016) improved metastatic survival...(3) In prostate cancer, enzalutamide plus leuprolide improved survival in high-risk biochemical recurrence (EMBARK). Capivasertib plus abiraterone benefited PTEN-deficient metastatic hormone-sensitive disease (CAPItello-281). The PSMAddition trial demonstrated that adding [177Lu]Lu-PSMA-617 to standard therapy significantly improved radiographic PFS in PSMA-positive mHSPC. Docetaxel scheduling was optimized (ARASAFE), and an AI model (STAMPEDE) identified patients for AR inhibitor benefit. Novel agents like saruparib and pasritamig showed promise...The 2025 evidence establishes multiple new standards of care across GU cancers, emphasizing biomarker-driven strategies, immunotherapy integration, novel resistance mechanisms, and treatment optimization. This synthesis provides an evidence-based framework for updating guidelines and highlights the move toward more personalized management, while noting persistent challenges and future research needs.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog)
    |
    FOLH1 positive
    |
    Keytruda (pembrolizumab) • Imfinzi (durvalumab) • docetaxel • Loqtorzi (toripalimab-tpzi) • Xtandi (enzalutamide) • abiraterone acetate • Truqap (capivasertib) • Aidixi (disitamab vedotin) • Padcev (enfortumab vedotin-ejfv) • saruparib (AZD5305) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • leuprolide acetate for depot suspension • pasritamig (JNJ-8343)
    9d
    Saruparib in combination with androgen receptor pathway inhibitors in metastatic hormone-sensitive prostate cancer: EvoPAR-Prostate01. (PubMed, Future Oncol)
    Approximately 1800 participants (550 HRRm; 1250 non-HRRm) are randomized 1:1 to receive either saruparib plus physician's choice of ARPI (abiraterone plus prednisone/prednisolone, darolutamide, or enzalutamide) or placebo plus ARPI. Analyses of rPFS and OS will be conducted within each cohort by stratified log-rank test. Enrollment began in November 2023.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06120491; EU CT number is 2023-504214-30-00.
    Clinical • Journal • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency)
    |
    Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • saruparib (AZD5305)
    17d
    ASCERTAIN: A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (clinicaltrials.gov)
    P1, N=120, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Nubeqa (darolutamide) • saruparib (AZD5305)
    21d
    D7270C00001: A trial to learn how safe AZD9750 is and how well it works in people with metastatic prostate cancer when given with or without other anticancer drugs (2024-516976-14-00)
    P1/2, N=52, Not yet recruiting, AstraZeneca AB
    New P1/2 trial
    |
    saruparib (AZD5305)
    26d
    PARTHENON: Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours (clinicaltrials.gov)
    P1/2, N=180, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting | Trial completion date: Jul 2029 --> Mar 2030 | Trial primary completion date: Jul 2029 --> Mar 2030
    Enrollment open • Trial completion date • Trial primary completion date
    |
    saruparib (AZD5305)
    2ms
    Discovery of selective PARP1/CDK6 dual target inhibitors modulating Wnt signaling pathway for the treatment of TNBC. (PubMed, Bioorg Chem)
    Herein, we report the rational design and synthesis of a series of second-generation selective PARP1/CDK6 dual inhibitors, based on the structural features of the latest selective PARP1 inhibitor AZD5305...Furthermore, compared with first-generation inhibitors, PC8 displays improved metabolic stability in liver microsomes. As a novel selective PARP1/CDK6 dual inhibitor with improved pharmacological properties, PC8 represents a promising lead structure for further optimization of second-generation PARP1/CDK6 dual inhibitors for the treatment of TNBC.
    Journal
    |
    CDK6 (Cyclin-dependent kinase 6) • PARP2 (Poly(ADP-Ribose) Polymerase 2)
    |
    saruparib (AZD5305)
    2ms
    PARTHENON: Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours (clinicaltrials.gov)
    P1/2, N=180, Not yet recruiting, AstraZeneca
    New P1/2 trial
    |
    saruparib (AZD5305)
    2ms
    Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (clinicaltrials.gov)
    P1, N=41, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial completion date: Nov 2026 --> Apr 2026 | Trial primary completion date: Jul 2026 --> Feb 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    metformin • saruparib (AZD5305)
    2ms
    D5330C00004: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents (clinicaltrials.gov)
    P1/2, N=357, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
    |
    HER-2 negative • HRD • PALB2 mutation • RAD51C mutation • BRCA mutation
    |
    Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • ceralasertib (AZD6738) • saruparib (AZD5305)
    2ms
    A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With Advanced/Recurrent Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, AstraZeneca | N=30 --> 0 | Trial completion date: Mar 2029 --> Dec 2025 | Active, not recruiting --> Withdrawn | Trial primary completion date: Mar 2029 --> Dec 2025
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset)
    |
    saruparib (AZD5305)
    2ms
    D9727C00001: A study to evaluate the impact on metastases-free survival with the addition of saruparib vs placebo to a standard radiotherapy androgen deprivation regimen in men with high-risk prostate cancer with a BRCA mutation. (2024-513586-39-00)
    P2/3, N=253, Recruiting, AstraZeneca AB
    New P2/3 trial
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    abiraterone acetate • saruparib (AZD5305)