budigalimab (ABBV-181) / AbbVie - LARVOL DELTA

First-in-human study of ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors. (ASCO 2024) - P1 | " Phase 1, open-label, multicenter, DE and dose-expansion study (NCT05599984) of ABBV-706 as monotherapy or in combination with budigalimab (a programmed cell death 1 inhibitor), carboplatin, or cisplatin. ABBV-706 demonstrated a manageable safety profile with promising efficacy in SCLC and NENs. Further evaluation of ABBV-706 is ongoing."

Clinical • Metastases • P1 data • Anemia • Brain Cancer • CNS Disorders • CNS Tumor • Endocrine Cancer • Epilepsy • Fatigue • Gastrointestinal Disorder • Glioma • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • SEZ6

Telisotuzumab Adizutecan and PD-1 Inhibitor in Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer: A Phase 1b/2 Study (IASLC-WCLC 2026) - P1, P1/2 | "Budigalimab is an investigational programmed cell death receptor 1 (PD-1) inhibitor with a mechanism of action similar to the approved pembrolizumab in these patients...In Part 2, 240 patients will be randomized 1:1:1 to receive selected doses of Temab-A + pembrolizumab or standard-of-care treatment (pembrolizumab + pemetrexed + investigator's choice of carboplatin or cisplatin), followed by pembrolizumab + pemetrexed for up to ~33 months...Additional secondary endpoints are subgroup analyses of ORR, PFS, OS, DOR, and DCR by PD-L1 and c-Met expression and history of brain metastases. Exploratory efficacy endpoints include intracranial OR, PFS and DOR by BICR, and patient-reported outcomes."

First-in-human • IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PD-L1

ABBV-706 as monotherapy and in combination with budigalimab in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC). (ASCO 2026) - P1 | "ABBV-706 monotherapy shows promising OS benefit in a heavily pretreated pt population with R/R SCLC and is combinable with a CPI. Efficacy of ABBV-706 in R/R SCLC. aConfirmed by investigator per RECIST v1.1."

Clinical • Combination therapy • Monotherapy • CNS Disorders • Epilepsy • Lung Cancer • Oncology • Pneumonia • Small Cell Lung Cancer • Solid Tumor • SEZ6

A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - P1 | N=3 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=20 ➔ 3 | Trial completion date: Oct 2027 ➔ Feb 2027 | Trial primary completion date: Oct 2027 ➔ Feb 2027

Adverse events • Checkpoint inhibition • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with fluorouracil, leucovorin, and budigalimab in locally advanced/metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (a/m GEA). (ASCO 2025) - P1, P2 | "Treatment is administered until disease progression, intolerable toxicity, or other discontinuation criteria are met. Either archived formalin-fixed paraffin-embedded tissue or a fresh biopsy is required for biomarker research that will include evaluation of c-Met protein expression and MET genomic alterations."

Combination therapy • IO biomarker • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • HER-2 • MET • PD-L1

LIVIGNO-2: A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - P2/3 | N=89 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=660 ➔ 89 | Trial completion date: Sep 2030 ➔ Jan 2027 | Trial primary completion date: Sep 2030 ➔ Jan 2027

Adverse events • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

A phase II/III study to evaluate the optimal dose, safety, and efficacy of livmoniplimab (Livmo) in combination with budigalimab (Budi) plus chemotherapy (CT) vs pembrolizumab (Pembro) plus CT in untreated metastatic non-small cell lung cancer (mNSCLC) (ESMO 2024) - P2/3 | "Enrollment is ongoing in ∼200 sites globally. Table: 1393TiP RP3D, recommended phase III dose; BOR, best overall response; C/PR, complete/partial response; Inv, investigator; PFS, progression-free survival; DOR, duration of response; OS, overall survival; PRO, patient reported outcome; BICR, blinded central review"

Clinical • Combination therapy • IO biomarker • Metastases • P2/3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-1 • PD-L1 • TGFB1

Phase 1b/2 study evaluating telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with budigalimab in patients (pts) with advanced non-squamous (NSQ) non-small cell lung cancer (NSCLC) with no prior treatment for advanced disease and no actionable genomic alterations. (ASCO 2025) - P1, P1/2 | "Pts are randomized 1:1:1:1 to Temab-A at 1 of 2 doses determined in part 1 + budigalimab, to budigalimab + CT, or to SOC (pembrolizumab + CT) arms...Treatment continues until disease progression, intolerable toxicity, or other discontinuation criteria are met. The first dosing of the first patient enrolled is planned in March 2025."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PD-L1

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

First-in-human study of ABBV-011, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate, in patients with small cell lung cancer. (ASCO 2023) - P1 | " Phase 1, open-label, multicenter study (NCT03639194) of ABBV-011 alone or in combination with budigalimab, a programmed cell death 1 inhibitor. The MTD was not reached and ABBV-011 was well tolerated at 1.0 mg/kg with promising antitumor activity observed. Further evaluation of ABBV-011 is ongoing. Clinical trial information: NCT03639194."

Clinical • P1 data • Anorexia • Cardiovascular • CNS Disorders • Epilepsy • Fatigue • Hematological Disorders • Hepatology • Hypertension • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Oncology • Portal Hypertension • Pulmonary Disease • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

A phase 2, open-label, randomized study of livmoniplimab in combination with budigalimab versus chemotherapy in patients with metastatic urothelial carcinoma. (ASCO 2025) - P1, P2 | "While immune checkpoint inhibitors (CPI), including programmed cell death protein 1 (PD-1) inhibitors combined with chemotherapy (CTx) or enfortumab vedotin (EV), have been approved for first-line treatment of metastatic (m)UC, many pts have de novo or develop acquired resistance...Pts will be randomized 1:1:1 to 3 arms: 1) livmo dose 1 Q3W + budi Q3W; 2) livmo dose 2 Q3W + budi Q3W; or 3) investigator's choice of CTx (paclitaxel, docetaxel, or gemcitabine). Pts will be stratified by ECOG PS (0 vs 1) and first-line therapy (pembrolizumab + EV vs CTx)...For all pts, treatment is discontinued at disease progression or if other protocol-defined discontinuation criteria are met. In total, approximately 150 pts (50 pts/arm) are planned for enrollment globally."

Clinical • Combination therapy • Metastases • P2 data • Oncology • Solid Tumor • Urothelial Cancer • TGFB1

Livmoniplimab with or without budigalimab in patients with advanced solid tumors: Results from the combination therapy in the urothelial carcinoma dose expansion cohort. (ASCO-GU 2024) - P1 | "Clinical Trial Registration Number: NCT03821935 Sponsored by AbbVie Background: Checkpoint inhibitors (CPIs) are approved for treating advanced urothelial carcinoma (UC). Livmo + budi had manageable safety and promising efficacy in pts with advanced UC that progressed on platinum-based therapy and a CPI. ORR in the UC cohort (pts postprogression with platinum + CPI therapy) are comparable with ORR in CPI-naive pts with pembrolizumab (KEYNOTE-045) and nivolumab (CheckMate 275) monotherapy. A subpopulation of pts in the UC cohort had a durable response to livmo + budi."

Clinical • Combination therapy • Metastases • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD4 • TGFB1

Budigalimab: a viable option for patients with advanced solid tumors. (PubMed, Expert Opin Investig Drugs) - "Phase II and phase III data are still pending but promising trials are currently running across various tumor types. Budigalimab is a new PD1 targeted immune checkpoint that is likely to be developed within association to other anticancer drugs within the Abbvie pipeline."

IO biomarker • Journal • Review • Lung Cancer • Oncology • Solid Tumor

AndroMETa-GEA: A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=185 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Budigalimab 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=172 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Budigalimab 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=172 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 | Sponsor: AbbVie | N=132 ➔ 252

Adverse events • Checkpoint inhibition • Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PD-L1

TTX-030-003: Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients (clinicaltrials.gov) - P2 | N=194 | Completed | Sponsor: Trishula Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2027 ➔ Mar 2026 | Trial primary completion date: Feb 2027 ➔ Nov 2025

Trial completion • Trial completion date • Trial primary completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

M23-385: Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=288 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Jun 2026 ➔ Nov 2027 | Trial primary completion date: Jun 2026 ➔ Nov 2027

Adverse events • First-in-human • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • EGFR • SEZ6

Livmoniplimab and budigalimab combination therapy in treating patients with metastatic ovarian granulosa cell tumors: Results from dose escalation in a first-in-human study (AACR 2024) - P1 | "Several agents with different targets, such as pembrolizumab, nirogacestat, orteronel, and STM 434, are being evaluated but to date have not shown clinical benefit...She had received 7 prior lines of therapy including doxorubicin, bevacizumab, anastrozole, tamoxifen, and carboplatin + paclitaxel... Livmo + budi had promising antitumor efficacy and a tolerable safety profile in pts with metastatic OGC, a rare TGF-β signaling-dependent tumor. All enrolled pts with OGC showed tumor shrinkage and 1 pt had durable and near-complete response. Since single-agent pembrolizumab exhibited an ORR of 0% in pts with OGC (How et al."

Clinical • Combination therapy • First-in-human • IO biomarker • Metastases • P1 data • Oncology • Ovarian Cancer • FOXL2 • TGFB1

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) - P1b | "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."

IO biomarker • Journal • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IFNG

ABBV-514: an afucosylated CCR8 specific antibody that targets and eliminates key immunosuppressive tumor regulatory T cells (AACR 2025) - P1 | "ABBV-514 is currently being evaluated in a Phase I clinical trial, both as a monotherapy and in combination with budigalimab, a PD-1-blocking antibody (NCT05005403). The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication."

IO biomarker • Oncology • Solid Tumor • CCR8 • CD8 • GZMK • LAG3

Safety, Pharmacokinetics, and Pharmacodynamics of Single-Dose Programmed Cell Death Protein 1 Inhibitor, Budigalimab, in People With HIV-1 With Antiretroviral Therapy-Suppressed Viral Load. (PubMed, J Infect Dis) - "Findings suggest an acceptable safety profile for single-dose budigalimab in PWH, with a favorable pharmacokinetic profile for 20 mg SC and 10 mg IV. Further evaluation as a potential component of an HIV treatment is underway."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Pneumonia • Respiratory Diseases

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 | Sponsor: AbbVie | N=512 ➔ 694 | Trial primary completion date: Jul 2026 ➔ Jul 2027

Adverse events • Enrollment change • First-in-human • Trial primary completion date • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • High Grade Serous Ovarian Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-1

Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=184 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2022 ➔ Jul 2022 | Trial primary completion date: Oct 2022 ➔ Jul 2022

Enrollment open • First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck