marked.bio

PD-L1/VEGF bispecific antibody · bispecific antibody

pumitamig

5 active trials across 4 of our biomarkers, targeting PD-L1 x VEGF. Not approved for any biomarker on marked.bio yet.

Also known as BNT327, PM8002.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 3 3 Phase 1/2
ALK fusion 2 2 Phase 1/2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 2 2 Phase 1/2
ROS1 fusion 1 1 Phase 1/2

Sponsors

Industry sponsors leading active biomarker-selected trials of pumitamig.

  1. BioNTech 3
  2. Bristol Myers Squibb 1
  3. DualityBio 1

Trials

5 of 5 trials shown

  1. A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

    Recruiting Phase 1/2 BioNTech Started 2025Primary completion 2028-03 NCT07070232

    YL202pumitamigitraconazoleparoxetine

    …est results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).

    EGFR exon 19 deletion / L858RAdvanced Solid Tumor

  2. A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2025Primary completion 2031-02 NCT06618287

    izalontamab brengitecanosimertinib FDA EUpembrolizumabnivolumabpumitamig

    …ants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, w…

    EGFR exon 19 deletion / L858RLung Cancer, Breast Cancer

  3. 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)

    Recruiting Phase 1/2 BioNTech Started 2025Primary completion 2028-11 NCT07111520

    YL202pumitamig

    …est results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).

    EGFR exon 19 deletion / L858RALK fusionROS1 fusionNon-small Cell Lung Cancer

  4. DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

    Recruiting Phase 2 DualityBio Started 2025Primary completion 2030-06 NCT06953089

    DB-1311pumitamigDB-1305

    Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations

    ALK fusionHER2-low / ultralow (IHC 1+ or 2+/ISH-)Solid Tumors

  5. 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

    Recruiting Phase 1/2 BioNTech Started 2025Primary completion 2029-08 NCT06827236

    DB-1303trastuzumabpumitamig

    …s a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Cli…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer