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    DRUG:

    gotistobart (BNT316)

    i
    Other names: BNT316, ONC-392, ONC 392, BNT 316, BNT-316, ONC392
    Company:
    BioNTech, OncoC4
    Drug class:
    CTLA4 inhibitor
    Related drugs:
    8d
    LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=320, Recruiting, BioNTech SE | N=156 --> 320
    Enrollment change • First-in-human
    |
    ALK (Anaplastic lymphoma kinase) • LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • RET rearrangement
    |
    Tagrisso (osimertinib) • carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • gotistobart (BNT316) • BNT116
    8d
    PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=58, Active, not recruiting, OncoC4, Inc. | Trial primary completion date: Oct 2025 --> Aug 2026
    Trial primary completion date • Platinum resistant
    |
    Keytruda (pembrolizumab) • gotistobart (BNT316)
    13d
    PRESERVE-009: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, OncoC4, Inc. | Trial primary completion date: Dec 2025 --> Jul 2026
    Trial primary completion date
    |
    gotistobart (BNT316) • AI-061
    25d
    Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. (PubMed, Nat Med)
    Stage 1 results suggest that gotistobart monotherapy can provide clinically meaningful benefit for patients with programmed cell death protein/programmed death ligand 1-resistant and chemotherapy-resistant metastatic sqNSCLC. ClinicalTrials.gov identifier: NCT05671510 .
    P3 data • Journal
    |
    PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    docetaxel • gotistobart (BNT316)
    2ms
    PRESERVE-003: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (clinicaltrials.gov)
    P3, N=630, Recruiting, OncoC4, Inc. | Trial completion date: Jun 2027 --> Aug 2028 | Trial primary completion date: Jun 2026 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    docetaxel • gotistobart (BNT316)
    5ms
    PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov)
    P1/2, N=148, Active, not recruiting, OncoC4, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • gotistobart (BNT316)
    9ms
    PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=58, Active, not recruiting, OncoC4, Inc. | Trial primary completion date: Jun 2025 --> Oct 2025
    Trial primary completion date • Platinum resistant
    |
    Keytruda (pembrolizumab) • gotistobart (BNT316)
    11ms
    Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors (ChiCTR2500103006)
    P3, N=600, Recruiting, Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci
    New P3 trial
    |
    LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    docetaxel • gotistobart (BNT316)
    11ms
    PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov)
    P1/2, N=733, Active, not recruiting, OncoC4, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • docetaxel • gotistobart (BNT316)
    12ms
    LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=220, Recruiting, BioNTech SE | N=160 --> 220 | Trial completion date: Nov 2028 --> Nov 2031 | Trial primary completion date: Apr 2027 --> Feb 2030
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 expression
    |
    carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • gotistobart (BNT316) • BNT116
    1year
    PRESERVE-009: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, OncoC4, Inc. | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Dec 2024 --> Dec 2025 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    gotistobart (BNT316) • AI-061
    over1year
    PRESERVE-003: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (clinicaltrials.gov)
    P3, N=600, Recruiting, OncoC4, Inc. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    docetaxel • gotistobart (BNT316)