Dr. Berdeja on Next Steps With JNJ-4528 in Relapsed/Refractory Myeloma

Jesus G. Berdeja, MD, the director of Multiple Myeloma Research at Sarah Cannon Research Institute, discusses next steps for the phase 2 CARTITUDE-1 study with JNJ-4528 in relapsed/refractory myeloma.

The phase 1b/2 CARTITUDE-1 trial enrolled patients with relapsed/refractory multiple myeloma and treated them with the BCMA-targeted CAR T therapy JNJ-4528. The second phase of the study is fully enrolled, says Berdeja. The goal is to combine the data observed with the agent from both phases of the trial to determine its efficacy in this patient population, adds Berdeja. Although this was a phase 1b trial, it was not a dose-escalation trial, clarifies Berdeja. The dose used in the phase 2 portion (0.73x106 CAR plus viable T cells/kg) was the same dose used in the LEGEND trials. The patient population should be fluid, and therefore, it will be the same dose for both phases of the trial.

Data from the phase 2 portion of the trial are highly anticipated, along with longer-term results, says Berdeja. The hope is that the data will reveal how durable responses to the agent will be, although the results that have been seen so far are very encouraging, adds Berdeja.

In March 2020, JNJ-4528 received a breakthrough therapy designation by the FDA, and Berdeja is hopeful that it will be one of the first candidates to obtain FDA approval for patients with relapsed/refractory multiple myeloma. Phase 2 and 3 studies are examining this product in earlier lines of therapy, including high-risk populations, potentially asfrontline consolidation, concludes Berdeja.