New Hope for Multiple Myeloma Patients: Isatuximab Combo Shows Promise

Introduction

The FDA recently granted priority review to the supplemental biologics license application (sBLA) for isatuximab-irfc (Sarclisa) in combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd). This combination is designed to help patients with newly diagnosed, transplant-ineligible multiple myeloma.

Why is This Significant?

Isatuximab is a monoclonal antibody that targets CD38, a protein found on the surface of myeloma cells. By adding this drug to the existing VRd regimen, patients could experience better outcomes. The combination aims to reduce the risk of disease progression or death, providing a new frontline therapy option for patients who cannot undergo a transplant.

European Union Involvement

This combination therapy is not just gaining attention in the U.S.; a regulatory submission is also under review in the European Union. This global approach shows the broad potential impact of this new therapy in treating multiple myeloma.

IMROZ Trial Data

The sBLA submission is backed by data from the phase 3 IMROZ trial, which assessed the efficacy of adding isatuximab to the VRd combination. The trial's findings will be presented at both the 2024 ASCO Annual Meeting and the 2024 EHA Congress, emphasizing their significance.

The IMROZ trial was a global, multicenter study that included 446 patients who either were 65 or older or had other health issues making them ineligible for transplant. Patients with inadequate organ function or those under 18 were excluded from the trial.

Trial Methodology

Participants in the trial were randomly assigned to receive either isatuximab plus VRd or VRd alone. In the experimental group, patients received intensive therapy with isatuximab for up to 17 cycles, combined with VRd initially and later with lenalidomide and dexamethasone. The aim was to continue treatment until disease progression or unacceptable side effects occurred.

Primary and Secondary End Points

The primary end point for the trial was progression-free survival (PFS), which measures the length of time during and after treatment that the patient lives without disease progression. Secondary end points included various measures of treatment effectiveness, such as complete response rate, minimal residual disease (MRD) negativity rate, and overall survival, among others.

Safety Profile

The combination of isatuximab and VRd showed a safety profile consistent with the known side effects of these medications. This is promising news for patients and healthcare providers looking for effective, yet manageable, treatment options.

Implications for Myeloma Treatment

Dietmar Berger, MD, PhD, from Sanofi, highlighted that despite recent advancements, there is still a significant unmet need for new treatments, especially for patients who cannot undergo a transplant. The priority review by the FDA and the EU's involvement signify the substantial potential of this new combination therapy.

Next Steps

The FDA has set a target decision date of September 27, 2024. If approved, this would be the first anti-CD38 monoclonal antibody combined with the standard VRd regimen for frontline treatment in newly diagnosed multiple myeloma patients who are ineligible for transplant.

Researchers and healthcare professionals are eagerly awaiting the final results and approval, which could herald a new era in the treatment of this challenging cancer.