budigalimab (ABBV-181) / AbbVie - LARVOL DELTA

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."

Journal • Review • Oncology • Ovarian Cancer • Solid Tumor • MUC4

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 | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • First-in-human • Monotherapy • Squamous Cell Carcinoma

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 | Sponsor: AbbVie

Adverse events • First-in-human • Monotherapy • New P1 trial • Squamous Cell Carcinoma

Analytical treatment interruption as a tool in the evaluation of immune-mediated interventions for long-term antiretroviral-free control of HIV-1 among people with HIV. (PubMed, Contemp Clin Trials) - "By sharing this study design, we hope to inform on the lessons learned from operationalizing a global study evaluating durable ART-free viral control, including the critical role of engaging members of the HIV community during clinical trial design to ensure the success of an ATI-inclusive study."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Global safety profile of PD-1/PD-L1 inhibitors in hepatic autoimmune disorders: A global disproportionality analysis. (PubMed, Medicine (Baltimore)) - "The analysis centered on PD-1/PD-L1 inhibitors, classified by Anatomical Therapeutic Chemical codes (e.g., atezolizumab, avelumab, budigalimab, cemiplimab, dostarlimab, durvalumab, nivolumab, pembrolizumab, sintilimab, spartalizumab, and tislelizumab). Most PD-1/PD-L1 inhibitors showed pharmacovigilance signals for hepatic autoimmune disorders, particularly nivolumab and pembrolizumab. Although our findings do not permit causal inference, these findings underscore the necessity for sustained hepatic monitoring, risk stratification, and appropriate therapeutic management."

Journal • Observational data • Immunology • Oncology

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 | Sponsor: 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 • First-in-human • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

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 | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • First-in-human • Monotherapy • Brain Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • EGFR • SEZ6

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 | Sponsor: AbbVie | Completed ➔ Terminated; Company Decision

Adverse events • Trial termination • Human Immunodeficiency Virus • Infectious Disease • CD4

Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study. (PubMed, Nat Med) - P1b | "The study achieved prespecified endpoints, supporting further evaluation of budigalimab in PLWH in a phase 2 study. ClinicalTrials.gov identifier: NCT04223804 ."

Clinical • Journal • P1 data • Endocrine Disorders • Human Immunodeficiency Virus • Infectious Disease • CD8

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 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed | Trial completion date: Mar 2027 ➔ Sep 2025 | Trial primary completion date: Mar 2027 ➔ Sep 2025

Adverse events • Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

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=660 | Recruiting | Sponsor: AbbVie | Active, not recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • 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=350 | Recruiting | Sponsor: AbbVie | Trial completion date: Nov 2027 ➔ Jun 2026 | Trial primary completion date: Nov 2027 ➔ Jun 2026

Adverse events • 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

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=163 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Sep 2025 ➔ Mar 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

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 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

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

LIVIGNO-3: Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC) (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor • Urothelial Cancer

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

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 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

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio (PRNewswire) - "AbbVie...announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers."

Clinical data • B Cell Non-Hodgkin Lymphoma • Castration-Resistant Prostate Cancer • Prostate Cancer • Urothelial Cancer

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab (clinicaltrials.gov) - P1 | N=512 | Recruiting | Sponsor: AbbVie | N=268 ➔ 512 | Trial completion date: May 2026 ➔ Jul 2027

Adverse events • Enrollment change • Platinum resistant • Trial completion date • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • High Grade Serous Ovarian Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

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=364 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

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

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=660 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Hepatocellular 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

Trosunilimab Safety, Pharmacokinetics, and Pharmacodynamics in People With and Without HIV-1 (CROI 2025) - "Conclusions The phase 1 studies showed that trosunilimab was well-tolerated in healthy volunteers and in PWH. The safety, PK/PD, and immunogenicity data from phase 1 studies allowed dose selection for the ongoing phase 2 study, M19-965, evaluating combinations of trosunilimab and budigalimab in PWH undergoing analytic treatment interruption."

Clinical • Late-breaking abstract • PK/PD data • Gastroenterology • Hepatology • Human Immunodeficiency Virus • Infectious Disease