Clinical trials evaluating CAR T-cell treatment in newly diagnosed myeloma

This week's "Ask Dr. Durie" comes from a patient who is interested in the current status of CAR T treatment for myeloma. As many of you are probably aware, CAR T treatment has recently been approved for treating relapsed or refractory multiple myeloma. And two products have been approved. However, the question here is: "What is the status of looking at this very promising treatment earlier in the disease course?"

Well, the results in relapsed/refractory disease have been incredibly promising. With the cilta-cel product, for example, in the quarter two trials. The response rate was 98% after a two-year follow-up.

And so, there is a reasonable excitement about possibly looking at earlier benefits from CAR T treatment. Now, in this case, the CAR T treatment is the use of engineered T cells.

So the patient's T cells are used, engineered to target the BCMA on the surface of the myeloma. And so this is a very, very good way to attack the myeloma. So two trials have been developed to evaluate these CAR T treatments earlier in the disease.  The CARTITUDE-5 trial is intended for patients where there is no plan for an autologous transplant. These are more older patients. 

In this trial, patients are treated with the combination of Velcade, REVLIMID, and dexamethasone, and in half of the patients, the treatment is added as a consolidation in the CARTITUDE-6 trial. This is intended for patients who would typically be receiving an autologous stem cell transplant. In this case, half of the patients will indeed receive an autologous stem cell transplant and the other half of the patients will receive the CAR T treatment as a consolidation instead.

And so, this is a head-to-head comparison, and I think that in this case, there's a particular interest in what will be the comparative benefit of CAR T treatment used in this early setting. Both of these trials are in patients with newly diagnosed multiple myeloma. So, as part of the first treatment combination, what will be the outcome?

So, the BOTTOM LINE is that these trials are eagerly awaited. However, there is a sense of caution. We need to see how well the treatment be tolerated when used in this way? What will be the logistics? What will be the access? Because we know that the CAR T cells have to be sent off and that treatment is given at specialized centers.

What about the costs? What about the patient experience? Will this be a tolerable approach for the average patient? And so, there are a lot of questions, despite the enthusiasm about the possible benefit of CAR T treatment used in this way. So, the answer to this question is yes, there are trials, the CARTITUDE-5, and the CARTITUDE-6, and there are many others in the works.

And so, this will be a whole new area of development for the new immune therapies that we're all so excited about.