livmoniplimab (ABBV-151) / AbbVie, argenx - LARVOL DELTA

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

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

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

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

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

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 | Not yet recruiting | Sponsor: AbbVie

First-in-human • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

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 • First-in-human • 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

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=362 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Feb 2026 ➔ Jun 2027

First-in-human • Trial primary completion date • Colorectal Cancer • Gastrointestinal 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

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=337 | Recruiting | Sponsor: AbbVie | Trial completion date: Feb 2026 ➔ Jun 2027

First-in-human • Trial completion date • Colorectal Cancer • Gastrointestinal 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

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=337 | Recruiting | Sponsor: AbbVie | Trial completion date: Apr 2024 ➔ Feb 2026 | Trial primary completion date: Apr 2024 ➔ Feb 2026

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal 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

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=260 | Recruiting | Sponsor: AbbVie | Trial completion date: Oct 2023 ➔ Apr 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

First-in-human • Trial completion date • Trial primary completion date • Gastrointestinal 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

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=260 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Oct 2023 ➔ Apr 2023

First-in-human • Trial primary completion date • Gastrointestinal 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

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=260 | Recruiting | Sponsor: AbbVie | Trial completion date: Apr 2023 ➔ Oct 2023 | Trial primary completion date: Apr 2023 ➔ Oct 2023

First-in-human • Trial completion date • Trial primary completion date • Gastrointestinal 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

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=260 | Recruiting | Sponsor: AbbVie | N=184 ➔ 260 | Trial primary completion date: Jul 2022 ➔ Apr 2023

Enrollment change • First-in-human • Trial primary completion date • Colorectal Cancer • Gastrointestinal 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

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 | Trial completion date: Jul 2022 ➔ Apr 2023

First-in-human • Trial completion date • Colorectal Cancer • Gastrointestinal 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

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 | Sponsor: AbbVie | Active, not recruiting ➔ Recruiting | N=167 ➔ 840

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

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 | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=840 ➔ 167

Adverse events • Enrollment change • Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

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

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

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

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

Livmoniplimab and budigalimab for patients with metastatic ovarian granulosa cell tumors: results from Phase 1 study (JSMO 2025) - No abstract available

Clinical • Metastases • P1 data • Oncology • Ovarian Cancer

Livmoniplimab and budigalimab for advanced solid tumors: Results from dose expansion cohort for urothelial carcinoma (JSMO 2025) - No abstract available

Metastases • Oncology • Solid Tumor • Urothelial Cancer