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    DRUG:

    sasanlimab (PF-06801591)

    i
    Other names: PF-06801591, PF-6801591, PF6801591, PF 6801591, RN-888 , PF06801591, PF 06801591, RN888, RN 888
    Company:
    Pfizer
    Drug class:
    PD1 inhibitor
    Related drugs:
    7d
    Treatment of non-muscle-invasive bladder cancer (PubMed, Urologie)
    The therapeutic landscape of NMIBC is undergoing rapid evolution. Combination strategies and novel intravesical therapies have the potential to expand the role of BCG to reduce recurrence and progression rates and further establish bladder-preserving treatment paradigms.
    Review • Journal
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    Imfinzi (durvalumab) • sasanlimab (PF-06801591)
    1m
    A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=399 --> 9 | Trial completion date: Sep 2029 --> Apr 2026 | Trial primary completion date: Sep 2028 --> Mar 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    sasanlimab (PF-06801591)
    1m
    A Study to Learn About the Study Medicine PF-07985045 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Change in a Gene. (clinicaltrials.gov)
    P1, N=26, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=190 --> 26
    Enrollment closed • Enrollment change • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • cisplatin • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • oxaliplatin • leucovorin calcium • sasanlimab (PF-06801591) • PF-07284892
    3ms
    Therapeutic Intensification Based on Immune Checkpoint Inhibitors in Non-Muscle Invasive Bladder Cancer: State of the Art and Future Perspectives. (PubMed, Cancers (Basel))
    Therapeutic intensification using systemic immunotherapy applies to both BCG-unresponsive NMIBC, with a new target pathway (HLA-E/NKG2A), and BCG-naïve HR NMIBC, where the combination of BCG instillations and immunotherapy represents a major breakthrough.
    Review • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    HLA-E (Major Histocompatibility Complex, Class I, E) • KLRC1 (Killer Cell Lectin Like Receptor C1)
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • sasanlimab (PF-06801591) • cetrelimab (JNJ-63723283)
    3ms
    NKT2152-202: Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc) (clinicaltrials.gov)
    P2, N=18, Terminated, NiKang Therapeutics, Inc. | N=172 --> 18 | Trial completion date: Jun 2026 --> Sep 2025 | Active, not recruiting --> Terminated; This study was terminated as a result of Sponsor portfolio reprioritization.
    Enrollment change • Trial completion date • Trial termination
    |
    Ibrance (palbociclib) • sasanlimab (PF-06801591) • imdatifan (NKT2152)
    3ms
    A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines. (clinicaltrials.gov)
    P1, N=9, Terminated, Pfizer | Active, not recruiting --> Terminated; Study terminated as part of strategic considerations and not based on safety concerns.
    Trial termination • First-in-human
    |
    sasanlimab (PF-06801591)
    4ms
    A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer (clinicaltrials.gov)
    P1, N=294, Recruiting, Pfizer | Not yet recruiting --> Recruiting
    Enrollment open
    |
    sasanlimab (PF-06801591)
    4ms
    RAD-VACCINE: Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, The Methodist Hospital Research Institute | Recruiting --> Active, not recruiting | Trial completion date: Aug 2025 --> Apr 2027
    Enrollment closed • Trial completion date
    |
    sasanlimab (PF-06801591)
    5ms
    A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer (clinicaltrials.gov)
    P1, N=294, Not yet recruiting, Pfizer
    New P1 trial
    |
    sasanlimab (PF-06801591)
    5ms
    A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=220 --> 6 | Trial completion date: Apr 2029 --> Feb 2026 | Trial primary completion date: Jan 2029 --> Feb 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    sasanlimab (PF-06801591)
    6ms
    A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer (clinicaltrials.gov)
    P1, N=4, Terminated, Pfizer | Active, not recruiting --> Terminated; The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns
    Trial termination
    |
    sasanlimab (PF-06801591)
    8ms
    Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=155, Active, not recruiting, Pfizer | Phase classification: P2 --> P1/2 | Trial completion date: Apr 2025 --> Jun 2026
    Phase classification • Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • EGFR mutation • BRAF mutation • ALK translocation
    |
    sasanlimab (PF-06801591)