Jesus G. Berdeja, MD

Jesus G. Berdeja, MD, the director of Multiple Myeloma Research at Sarah Cannon Research Institute, discusses the dosing of the investigational CAR T-cell product JNJ-4528 in patients with ​relapsed/refractory multiple myeloma.

The median administered dose of JNJ-4528 in the ​phase 1b/2 CARTITUDE-1 trial was 0.72 x 106 CAR + viable T cells/kg,which is lower than other available CAR T-cell products, says Berdeja.

With this dosing strategy, a 70 kg patient would receive about 50 million CAR T cells, explains Berdeja. Although additional information is needed, making fewer CAR T cells may lead to less manufacturing failures.

Moreover, data from the ​CARTITUDE-1 trial showed that the ​median time to onset of cytokine release syndrome (CRS) was 7 days after receiving JNJ-4528. Comparatively, CRS can be observed immediately after infusion with other ​CAR T-cell products, Berdeja concludes.

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Jesus G. Berdeja, MD, discusses the dosing of the investigational CAR T-cell product JNJ-4528 in patients with ​relapsed/refractory multiple myeloma.

Dr.  Berdeja on Dosing JNJ-4528 in Relapsed/Refractory Multiple 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.

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.

Jesus G. Berdeja, MD, discusses next steps for the phase 2 CARTITUDE-1 study with JNJ-4528 in relapsed/refractory myeloma.


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 updated safety results from the ongoing phase 1b/2 CARTITUDE-1 trial (NCT03548207) with the CAR T-cell therapy JNJ-4528 in multiple myeloma.

In the study, neurotoxicity was rare; only 1 patient reported an event that was grade 3 or higher in severity, Berdeja says. Significant cytopenias were also observed with JNJ-4528, including neutropenia and thrombocytopenia, although most events resolved within 60 days, says Berdeja. All-grade upper respiratory tract infections were reported in 31% of the patients, however, none of these infections were unexpected, adds Berdeja.

Additionally, results showed a 100% overall response rate with the product, which included a stringent complete response rate of 86% and very good partial response rate of 97% at a median follow-up of 11.5 months, explains Berdeja.

Finally, 16 patients with a CR achieved minimal residual disease (MRD)–negative disease status. Of those patients, 81% were MRD negative at 10-5 or better and 69% were MRD negative at 10-6. The estimated progression-free survival rate at 9 months was 86%, concludes Berdeja.

Jesus G. Berdeja, MD, discusses updated safety results from the ongoing phase 1b/2 CARTITUDE-1 trial (NCT03548207) with the CAR T-cell therapy JNJ-4528 in multiple myeloma.

Dr. Berdeja on Updated CARTITUDE-1 Results With JNJ-4258 in Multiple Myeloma

Jesus G. Berdeja, MD, director of Myeloma Research, principal investigator, Sarah Cannon Research Institute, discusses the FDA approval of frontline daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Author | Jesus G. Berdeja, MD

Articles

Dr. Berdeja on Dosing JNJ-4528 in Relapsed/Refractory Multiple Myeloma

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

Dr. Berdeja on Updated CARTITUDE-1 Results With JNJ-4258 in Multiple Myeloma

Dr. Berdeja on FDA Approval of Frontline Daratumumab Plus VMP in Multiple Myeloma