Updated Results on Modakafusp Alfa (TAK-573) Safety and Efficacy; Phase 1/2 Study of RRMM Patients Presented at EHA 2022

Dr. Jonathan L. Kaufman Discusses Safety and Efficacy of Modakafusp Alfa (TAK-573); and Updated Clinical, Pharmacokinetic, and Immunogenicity Results from Phase 1/2 Study in RRMM Patients

Abstract Title:

Modakafusp Alfa (TAK-573): Updated Clinical, Pharmacokinetic (PK), and Immunogenicity Results from a Phase 1/2 Study in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) 

What is the purpose of this trial? 

Modakafusp alfa (TAK-573) is a first-in-class immunocytokine designed to deliver attenuated interferon alpha-2b to CD38+ cells. In this phase 1/2 study, the maximum tolerated dose of modakafusp alfa was defined as 3 mg/kg every 4 weeks (Q4W); preliminary data from 29 patients treated at 1.5 mg/kg Q4W (5 in dose escalation, 24 in dose expansion) showed single-agent, anti-myeloma activity with an overall response rate (ORR) of 38% after a median follow-up of 4.2 months (Vogl ASH 2021, #898).

A clinical update is presented on the efficacy and safety of modakafusp alfa 1.5 mg/kg Q4W after a median follow-up of 4.5 mos. Pharmacokinetic (PK), immunogenicity, and dose-exposure-response data from the overall study are also presented.

In this video:

Dr. Jonathan L. Kaufman (Department of Hematology and Medical Oncology, Emory University School of Medicine—Atlanta, GA) discusses safety and efficacy of modakafusp Alfa (TAK-573) as well as updates on clinical, pharmacokinetic, and immunogenicity results from Phase 1/2 Study in RRMM patients.

Conclusion:

Modakafusp alfa has a novel mechanism of action and has shown encouraging activity with a manageable safety profile in RRMM patients. Characterization of the potential clinical impact of immunogenicity is ongoing. The optimal dose for single-agent modakafusp alfa will be further investigated in a phase 2 study.

Clinical trial information: NCT03215030

Doctor Bio:

Jonathan L. Kaufman, MD is Professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia. Board certified in hematology and medical oncology, Dr. Kaufman's practice includes treating multiple myeloma and amyloidosis patients at Emory University Hospital. He is also an active clinical and translational researcher in the fields of multiple myeloma, amyloidosis, and bone marrow transplant. Dr. Kaufman is a member of the Discovery and Developmental Therapeutics Research Program at Winship Cancer Institute. He also holds memberships with American Society of Clinical Oncology and American Society of Hematology.