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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:
    22d
    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)
    22d
    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) • NKT2152
    28d
    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)
    1m
    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)
    1m
    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)
    2ms
    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)
    2ms
    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)
    4ms
    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)
    5ms
    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)
    6ms
    Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC) (clinicaltrials.gov)
    P1/2, N=100, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Jun 2027 | Trial primary completion date: Jun 2025 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Ibrance (palbociclib) • sasanlimab (PF-06801591)
    6ms
    A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov)
    P1, N=399, Recruiting, Pfizer | Not yet recruiting --> Recruiting | Trial completion date: Feb 2029 --> Jul 2029 | Trial primary completion date: Feb 2028 --> Jul 2028
    Enrollment open • Trial completion date • Trial primary completion date
    |
    sasanlimab (PF-06801591)
    6ms
    Study of PF-07265807 in Participants With Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=88, Terminated, Pfizer | N=67 --> 88 | Trial completion date: Jun 2024 --> Nov 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2024 --> Nov 2024; Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Inlyta (axitinib) • sasanlimab (PF-06801591) • PF-07265807