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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:
    6d
    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
    7d
    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)
    7d
    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)
    7d
    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)
    10d
    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=112, Recruiting, BioNTech SE | N=82 --> 112
    Enrollment change
    |
    pumitamig (BNT327) • BNT324
    10d
    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=288, Recruiting, Bristol-Myers Squibb
    New P2/3 trial
    |
    Avastin (bevacizumab) • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • pumitamig (BNT327)
    10d
    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=131, 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 • pumitamig (BNT327)
    14d
    BNT323-03: A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=380, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    trastuzumab pamirtecan (BNT323) • pumitamig (BNT327)
    14d
    ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=144, Recruiting, BioNTech SE | N=110 --> 144
    Enrollment change
    |
    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)
    14d
    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=82, Recruiting, BioNTech SE | N=52 --> 82
    Enrollment change
    |
    pumitamig (BNT327) • BNT324
    14d
    CA2660003: Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Previously Untreated, Unresectable, or Metastatic Colorectal Cancer. (2025-523224-45-00)
    P2/3, N=33, Not yet recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P2/3 trial
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600
    |
    Avastin (bevacizumab) • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • pumitamig (BNT327)
    14d
    CA2660004: Study of Pumitamig in Combination with Chemotherapy Versus Nivolumab innCombination with Chemotherapy in Previously Untreated Advanced or MetastaticnGastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (2025-523263-37-00)
    P2/3, N=40, Not yet recruiting, Bristol-Myers Squibb Services Unlimited Company
    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)