The 2022 Tandem Meetings | CARTITUDE-5: VRd + cilta-cel or Rd in newly diagnosed multiple myeloma

CARTITUDE-5 is a frontline, newly diagnosed study in patients who are either transplant-ineligible, or are deferring their stem cell transplant to the time of first relapse. The study is a randomization between patients receiving VRD, so all patients receive VRD as part of induction, but the randomization is after induction. Patients get randomized to either receiving cilta-cel, so the BCMA-directed CAR-T therapy, followed by observation. Or, patients go on to lenalidomide maintenance until relapse progression or intolerance.

The CARTITUDE-5 study is actively enrolling. I think, it’s a very important trial in this patient population, asking a very interesting question. We are all impressed with cilta-cel’s activity in the relapse setting. And in the advanced relapse setting in CARTITUDE-1, as well as in CARTITUDE-2 cohorts, of one to three prior lines of treatment showing, over 95% response rates and durability of response as well, at least, in the CARTITUDE-1 experience so far.

So the key question is, can you go from this continuous therapy model to a finite duration treatment model with this, introducing this effective treatment in the front-line setting? The primary endpoint for the study is MRD negativity, and it’s a time-dependent primary endpoint. But important secondary endpoints are PFS, overall response rate, CR or better rates, MRD negativity, sustain MRD negativity, as well as overall survival. So a very important study. I don’t think we are going to see a readout soon, but this will change the way that we think about approaching myeloma patients in the future. That’s the hope of these novel cellular therapies. Let’s hope it bears true.