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    DRUG:

    pumitamig (BNT327)

    i
    Other names: BNT327, BMS986545, PM8002, PM 8002, PM-8002, BNT 327, BNT-327, BMS-986545
    Company:
    BMS, BioNTech
    Drug class:
    PD-L1 inhibitor, VEGF-A inhibitor
    Related drugs:
    2d
    A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM (clinicaltrials.gov)
    P2, N=31, Completed, Biotheus Inc. | Recruiting --> Completed | N=55 --> 31 | Trial completion date: Jun 2026 --> Mar 2026 | Trial primary completion date: Jun 2026 --> Mar 2026
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • pemetrexed • pumitamig (BNT327)
    6d
    CA052-002: A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=1109, Recruiting, Bristol-Myers Squibb | Trial completion date: Jul 2028 --> Aug 2031 | Trial primary completion date: Jul 2028 --> Aug 2031
    Trial completion date • Trial primary completion date • First-in-human
    |
    Opdivo (nivolumab) • docetaxel • pumitamig (BNT327)
    8d
    A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) (clinicaltrials.gov)
    P1/2, N=198, Recruiting, Bristol-Myers Squibb | N=129 --> 198
    Enrollment change
    |
    Yervoy (ipilimumab) • pumitamig (BNT327)
    17d
    CA2660001: A Study of Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants with Unresectable Stage III NSCLC (2025-523576-23-00)
    P2/3, N=62, Not yet recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P2/3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • pumitamig (BNT327)
    19d
    PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=404, Active, not recruiting, Biotheus Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    paclitaxel • topotecan • pumitamig (BNT327)
    24d
    CA2660002: A Study of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ? 50% (2025-523586-18-00)
    P2/3, N=15, Not yet recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P2/3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • pumitamig (BNT327)
    28d
    DB-1311-201: DB-1311 in Combination with BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (2025-523895-22-00)
    P1/2, N=57, Not yet recruiting, Dualitybio Inc.
    New P1/2 trial
    |
    pumitamig (BNT327) • BNT324
    29d
    Ph1/2 Trial Of Navlimetostat With Pumitamig In MTAP-Deficient Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=17, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MTAP (Methylthioadenosine Phosphorylase) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    navlimetostat (BMS-986504) • pumitamig (BNT327)
    29d
    DB-1305-O-1001: First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=1123, Active, not recruiting, DualityBio Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Aug 2027
    Enrollment closed • Trial completion date • Trial primary completion date • First-in-human
    |
    Keytruda (pembrolizumab) • pumitamig (BNT327)
    1m
    ROSETTA GI 204: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) (clinicaltrials.gov)
    P2/3, N=690, Recruiting, Bristol-Myers Squibb
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • 5-fluorouracil • pumitamig (BNT327)
    1m
    ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2/3, N=990, Recruiting, Bristol-Myers Squibb
    Trial initiation date
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • pumitamig (BNT327)
    1m
    BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=420, Recruiting, BioNTech SE
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • BRAF mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • PD-L1 negative • RET mutation • MET mutation • EGFR negative
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pumitamig (BNT327) • BNT326 • MK-3475 SC