Bristol Myers Squibb and 2seventy bio Suspend KarMMa-9 Trial for Newly Diagnosed Multiple Myeloma Patients

**Bristol Myers Squibb and 2seventy bio Suspend KarMMa-9 Trial for Newly Diagnosed Multiple Myeloma Patients**

In a significant development within the field of oncology, Bristol Myers Squibb (BMS) and 2seventy bio have announced the suspension of the KarMMa-9 clinical trial, which was investigating the use of CAR T-cell therapy in newly diagnosed multiple myeloma patients. The decision to halt the trial has raised concerns and questions within the medical community, as CAR T-cell therapies have been seen as a promising avenue for treating various forms of cancer, including multiple myeloma.

### Background on Multiple Myeloma and CAR T-Cell Therapy

Multiple myeloma is a type of blood cancer that affects plasma cells, a type of white blood cell found in the bone marrow. These cancerous cells proliferate uncontrollably, leading to a range of complications, including bone damage, kidney dysfunction, and immune system suppression. While multiple myeloma remains incurable, advances in treatment have significantly improved patient outcomes in recent years.

One of the most promising advancements in cancer treatment has been the development of CAR T-cell therapy. This form of immunotherapy involves genetically modifying a patient’s T-cells to express a chimeric antigen receptor (CAR) that targets specific proteins on the surface of cancer cells. Once reintroduced into the patient’s body, these engineered T-cells can recognize and destroy cancer cells more effectively.

Bristol Myers Squibb and 2seventy bio have been at the forefront of developing CAR T-cell therapies for multiple myeloma. Their collaboration has led to the development of idecabtagene vicleucel (ide-cel), a CAR T-cell therapy that targets the B-cell maturation antigen (BCMA), a protein commonly found on the surface of multiple myeloma cells. Ide-cel has already been approved for use in patients with relapsed or refractory multiple myeloma, and the KarMMa-9 trial was designed to evaluate its efficacy in newly diagnosed patients.

### The KarMMa-9 Trial: Aims and Objectives

The KarMMa-9 trial was a Phase 3 clinical study aimed at evaluating the safety and efficacy of ide-cel in newly diagnosed multiple myeloma patients who were considered high-risk. High-risk patients are those who have certain genetic abnormalities or other factors that make their disease more aggressive and difficult to treat. The trial sought to determine whether ide-cel could improve outcomes for these patients when used earlier in the treatment process, as opposed to being reserved for later stages of the disease.

The trial was designed to compare ide-cel to standard-of-care treatments, which typically include a combination of chemotherapy, immunomodulatory drugs, and proteasome inhibitors. The hope was that ide-cel could offer a more effective and durable response, potentially leading to longer periods of remission and improved overall survival rates.

### Reasons for the Suspension

On October 2023, Bristol Myers Squibb and 2seventy bio announced the suspension of the KarMMa-9 trial. The companies cited safety concerns as the primary reason for halting the study. While specific details regarding the nature of these safety concerns have not been fully disclosed, it is not uncommon for CAR T-cell therapies to be associated with significant side effects, including cytokine release syndrome (CRS) and neurotoxicity.

Cytokine release syndrome is a potentially life-threatening condition that occurs when the immune system becomes overactivated in response to CAR T-cell therapy. Symptoms can range from mild flu-like symptoms to severe organ dysfunction and, in some cases, death. Neurotoxicity, another common side effect, can lead to confusion, seizures, and other neurological complications.

The decision to suspend the trial underscores the challenges associated with developing CAR T-cell therapies, particularly in newly diagnosed patients who may have different risk profiles compared to those with relapsed or refractory disease. While CAR T-cell therapies have shown remarkable efficacy in some patients, their safety profile remains a critical concern, especially when used in earlier stages of treatment.

### Implications for the Future of CAR T-Cell Therapy in Multiple Myeloma

The suspension of the KarMMa-9 trial is a setback for the development of CAR T-cell therapies in newly diagnosed multiple myeloma patients, but it does not signal the end of research in this area. Both Bristol Myers Squibb and 2seventy bio have emphasized their commitment to continuing the development of ide-cel and other CAR T-cell therapies for multiple myeloma.

It is important to note that ide-cel has already been approved for use in patients with relapsed or refractory multiple myeloma, and its efficacy in this population has been well-documented. The suspension of the KarMMa-9 trial highlights the need for further research to better understand the safety and efficacy of CAR T-cell therapies in different patient populations, particularly those who are newly diagnosed

• Source Link: https://platohealth.ai/bristol-myers-squibb-and-2seventy-bio-halt-karmma-9-trial-in-patients-with-newly-diagnosed-multiple-myeloma/