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    DRUG:

    budigalimab (ABBV-181)

    i
    Other names: ABBV-181, ABBV 181, ABBV181
    Company:
    AbbVie
    Drug class:
    PD1 inhibitor
    Related drugs:
    13d
    Phase 1b study of ABBV-368, tilsotolimod, budigalimab, and nab-paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma. (PubMed, J Immunother Cancer)
    The quadruple combination of ABBV-368, tilsotolimod, nab-paclitaxel, and budigalimab was well tolerated and demonstrated pharmacodynamic activity. Several patients had disease stabilization, but clinical responses were limited. Initial priming and T-cell immune activation were inadequate to overcome prior therapy resistance mechanisms including a hypothesized unfavorable tumor microenvironment. Future work investigating strategies to target this inhibitory tumor microenvironment with optimally scheduled immunotherapy combinations in selected patients and indications is urgently needed to improve patient outcomes.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma)
    |
    albumin-bound paclitaxel • budigalimab (ABBV-181) • revdofilimab (ABBV-368) • tilsotolimod (IMO-2125)
    19d
    Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan (clinicaltrials.gov)
    P1, N=694, Recruiting, AbbVie | N=512 --> 694 | Trial primary completion date: Jul 2026 --> Jul 2027
    Enrollment change • Trial primary completion date • Adverse events • First-in-human
    |
    PD-1 (Programmed cell death 1)
    |
    BRAF V600E • BRAF V600 • HER-2 mutation
    |
    Avastin (bevacizumab) • budigalimab (ABBV-181) • telisotuzumab adizutecan (ABBV-400)
    2ms
    LIVIGNO-4: Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=840, Recruiting, AbbVie | Active, not recruiting --> Recruiting | N=167 --> 840
    Enrollment open • Enrollment change • Adverse events
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
    3ms
    LIVIGNO-4: Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=167, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | N=840 --> 167
    Enrollment closed • Enrollment change • Adverse events
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
    3ms
    A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=163, Active, not recruiting, AbbVie | Trial completion date: Mar 2026 --> Sep 2026 | Trial primary completion date: Mar 2026 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    budigalimab (ABBV-181) • giloralimab (ABBV-927)
    3ms
    Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations (clinicaltrials.gov)
    P1/2, N=252, Recruiting, AbbVie | N=132 --> 252
    Enrollment change • Adverse events • Checkpoint inhibition
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR wild-type
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • budigalimab (ABBV-181) • telisotuzumab adizutecan (ABBV-400)
    4ms
    A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors (clinicaltrials.gov)
    P1, N=220, Recruiting, AbbVie | Trial completion date: Apr 2029 --> Oct 2030
    Trial completion date • Adverse events • First-in-human
    |
    budigalimab (ABBV-181)
    4ms
    A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors (clinicaltrials.gov)
    P1, N=220, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events • First-in-human
    |
    budigalimab (ABBV-181)
    5ms
    Therapeutic Applications and Target Strategies of Antibody-Drug Conjugates in Ovarian Cancer. (PubMed, Iran J Pharm Res)
    This review summarizes a range of ADCs targeting tumor-associated antigens in ovarian cancer, including mirvetuximab soravtansine (MIRV), trastuzumab deruxtecan (T-DXd), datopotamab deruxtecan (Dato-DXd), sacituzumab tirumotecan (SKB-264), PF-06664178, anetumab ravtansine (BAY 94-9343), BMS-986148, DMOT4039A, RC88, lifastuzumab vedotin (DNIB0600A), upifitamab rilsodotin (ABBV-181), ZW220, DMUC4064A, and sofituzumab vedotin (DMUC5754A). The ADCs hold significant potential to reshape the treatment landscape for ovarian cancer by providing targeted therapeutic options. Further research is required to optimize patient selection, address resistance mechanisms, and improve safety profiles.
    Review • Journal
    |
    MUC4 (Mucin 4, Cell Surface Associated)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Elahere (mirvetuximab soravtansine-gynx) • budigalimab (ABBV-181) • Datroway (datopotamab deruxtecan-dlnk) • Jiataile (sacituzumab tirumotecan) • anetumab ravtansine (BAY 94-9343) • upifitamab rilsodotin (XMT-1536) • RG7600 • lifastuzumab vedotin (DNIB0600A) • RG7882 • ZW220 • BMS-986148
    5ms
    A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors (clinicaltrials.gov)
    P1, N=220, Not yet recruiting, AbbVie
    New P1 trial • Adverse events • First-in-human
    |
    budigalimab (ABBV-181)
    6ms
    A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382 (clinicaltrials.gov)
    P2, N=163, Terminated, AbbVie | Completed --> Terminated; Company Decision
    Trial termination • Adverse events
    |
    CD4 (CD4 Molecule)
    |
    budigalimab (ABBV-181)
    6ms
    A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=27, Terminated, AbbVie | N=192 --> 27 | Trial completion date: Jan 2028 --> Oct 2025 | Recruiting --> Terminated | Trial primary completion date: Jan 2028 --> Oct 2025; Strategic considerations
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • First-in-human
    |
    budigalimab (ABBV-181)