Etentamig

Table of contents

• What is etentamig?
• How does etentamig work?
• Which conditions is etentamig being studied for?
• How is etentamig given?
• What do the clinical trials show?
• Who can take part in these trials?
• What side effects are known?

What is etentamig?

Etentamig is a protein-based substance, specifically an antibody, that is being developed as a potential treatment for multiple myeloma. It is classified as an investigational substance with no marketing authorisation in the product records.^[3] The substance is also known by the development code ABBV-383.^[6] The company supplying etentamig in these trials is AbbVie Deutschland GmbH & Co. KG.^[3]

How does etentamig work?

The registry records do not describe the molecular target of etentamig. As an antibody, it belongs to a class of medicines that are designed to bind to specific proteins on cells. The trials focus on measuring clinical activity in multiple myeloma, a cancer of plasma cells. Further details on its mechanism of action are not provided in the available data.

Which conditions is etentamig being studied for?

The clinical trials for etentamig cover two main settings of multiple myeloma:

• Newly diagnosed multiple myeloma not eligible for transplant, studied in a Phase 4 trial with 60 participants.^[3]
• Relapsed or refractory multiple myeloma, meaning the disease has returned or not responded to previous treatment, studied in a Phase 3 trial with 414 participants.^[1]
• Multiple myeloma broadly, including transplant-eligible and transplant-ineligible newly diagnosed disease, studied in a Phase 1 trial with 440 participants.^[4]

How is etentamig given?

Etentamig is prepared as a solution for infusion and is given by intravenous use.^[3] In one trial, it is also described as a solution for infusion given intravenously.^[4] A supplementary source mentions a Phase 1b study of etentamig administered subcutaneously in relapsed or refractory multiple myeloma, indicating that a subcutaneous formulation is also being investigated.^[6]

What do the clinical trials show?

Five authorised trials are listed for etentamig. They span Phase 1, Phase 3, and Phase 4, reflecting different stages of research. The trials measure outcomes such as overall response rate, complete response, minimal residual disease negativity, and progression-free survival.^[3][1]

The Phase 3 monotherapy study compares etentamig with standard available therapies in participants with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.^[1] The Phase 4 trial combines etentamig with daratumumab in newly diagnosed multiple myeloma not eligible for transplant.^[3] The Phase 1 trials explore etentamig alone or with other agents such as lenalidomide, carfilzomib, iberdomide, and surzetoclax.^[4][2][5]

The primary outcomes vary by trial. In the Phase 4 trial, outcomes include overall response rate, complete response or better, and minimal residual disease negative complete response rate.^[3] In the Phase 3 trial, progression-free survival and overall response rate per independent review committee are the primary measures.^[1] The Phase 1 trials focus on dose-limiting toxicities and adverse events.^[4][2][5]

Who can take part in these trials?

Eligibility depends on the trial. The Phase 3 monotherapy study enrolls adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy.^[1] The Phase 4 trial enrolls adults with newly diagnosed multiple myeloma who are not eligible for transplant.^[3] The Phase 1 trial includes participants with newly diagnosed multiple myeloma, both transplant-eligible and transplant-ineligible, as well as relapsed or refractory disease.^[4]

What side effects are known?

The available registry data do not list specific side effects for etentamig. The Phase 1 trials are designed to characterise safety, toxicity, and tolerability, including dose-limiting toxicities and adverse events.^[4][2][5] A supplementary source lists adverse reactions and pharmacokinetics as areas of focus in a Phase 1b study.^[6]