ABBV-453 / AbbVie - LARVOL DELTA

Surzetoclax ABBV-453: Phase 1 Dose Escalation Study of Next-Generation BCL-2 Inhibitor in Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ICML 2025) - No abstract available

P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM) (clinicaltrials.gov) - P1/2 | N=130 | Not yet recruiting | Sponsor: AbbVie

Adverse events • Monotherapy • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: AbbVie | Initiation date: Aug 2024 ➔ Jan 2025

Adverse events • Trial initiation date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Abbv-453: A Highly Potent and Selective Next Generation Small Molecule Inhibitor of BCL-2 (ASH 2024) - P1 | "ABBV-453 demonstrated superior growth inhibition of the RS4; 11 xenograft compared to both sonrotoclax or lisaftoclax at equivalent doses and schedule. ABBV-453 has the potential to be the best-in-class next-generation BCL-2 inhibitor and is actively being investigated in phase 1 clinical trials in relapsed or refractory (R/R) MM (ClinicalTrials.gov ID, NCT05308654) and R/R CLL/SLL (NCT06291220)."

Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • ANXA5 • BCL2 • BCL2L1 • BCL2L2 • CASP3 • CASP7 • MCL1

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=360 ➔ 34 | Trial completion date: Aug 2026 ➔ Dec 2025 | Trial primary completion date: Aug 2026 ➔ Feb 2024

Adverse events • Biomarker • Enrollment change • Enrollment closed • IO biomarker • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • BCL2

A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P1 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov) - P1 | N=360 | Recruiting | Sponsor: AbbVie | Trial completion date: Apr 2026 ➔ Aug 2026 | Trial primary completion date: Apr 2026 ➔ Aug 2026

Adverse events • Biomarker • IO biomarker • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • BCL2

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov) - P1 | N=360 | Recruiting | Sponsor: AbbVie | N=48 ➔ 360

Adverse events • Biomarker • Enrollment change • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • BCL2

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: AbbVie | N=21 ➔ 48

Adverse events • Biomarker • Enrollment change • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • BCL2

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Aug 2025 ➔ Apr 2026

Adverse events • Biomarker • IO biomarker • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • BCL2

New Funding Awards September 2022 (Duke University School of Medicine) - ""Robert Tighe of Pulmonary has received an award (1R01-ES034350-01) from the National Institutes of Health for a project entitled 'R01_Monocyte-derived alveolar macrophage drives inflammatory response to lung ozone exposure.' Total funding will be $3,002,300....Cristina Gasparetto of Cell Therapy has received an award from AbbVie Inc. for a project entitled 'First-in-Human Two-Part Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects with Relapsed or Refractory Multiple Myeloma.' Total funding will be $292,276."

Announcement

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Biomarker • Enrollment open • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • BCL2

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: AbbVie

Adverse events • Biomarker • IO biomarker • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology • BCL2