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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:
    1d
    A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=375, Recruiting, BioNTech SE | Trial completion date: Mar 2028 --> Aug 2028
    Trial completion date • First-in-human
    |
    pumitamig (BNT327)
    5d
    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 | N=184 --> 690
    Enrollment change • 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)
    10d
    A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) (clinicaltrials.gov)
    P3, N=850, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Imfinzi (durvalumab) • pumitamig (BNT327)
    11d
    A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) (clinicaltrials.gov)
    P3, N=750, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • pumitamig (BNT327)
    13d
    ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=558, Recruiting, BioNTech SE | N=144 --> 558
    Enrollment change • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • gemcitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • pumitamig (BNT327)
    13d
    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 | N=346 --> 990
    Enrollment change • Trial initiation date
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • pumitamig (BNT327)
    13d
    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=184, Recruiting, Bristol-Myers Squibb
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • pumitamig (BNT327)
    13d
    A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) (clinicaltrials.gov)
    P2, N=260, Not yet recruiting, Bristol-Myers Squibb
    New P2 trial
    |
    MTAP (Methylthioadenosine Phosphorylase)
    |
    Opdivo (nivolumab) • carboplatin • gemcitabine • temozolomide • albumin-bound paclitaxel • pemetrexed • navlimetostat (BMS‐986504) • Opdualag (nivolumab/relatlimab-rmbw) • daraxonrasib (RMC-6236) • pumitamig (BNT327)
    19d
    BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=594, Recruiting, BioNTech SE | N=112 --> 594
    Enrollment change
    |
    pumitamig (BNT327) • BNT324
    20d
    ROSETTA Lung-02: Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (clinicaltrials.gov)
    P2/3, N=656, Recruiting, BioNTech SE | N=470 --> 656
    Enrollment change
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • pumitamig (BNT327)
    20d
    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=346, Recruiting, Bristol-Myers Squibb
    New P2/3 trial
    |
    Avastin (bevacizumab) • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • pumitamig (BNT327)
    21d
    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 | N=288 --> 990
    Enrollment change • Trial initiation date
    |
    Avastin (bevacizumab) • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • pumitamig (BNT327)