19 May CARTITUDE-1 Study Shows Promise in Patients With Refractory Myeloma
MedicalResearch.com Interview with:
Dr. Jesus G. Berdeja, MD
Director of Myeloma Research
MedicalResearch.com: What is the background for this study?
Response: Despite many advances in the treatment of multiple myeloma in recent years, the majority of patients will progress through all available therapies and ultimately succumb to their disease. Thus there is still a high unmet medical need.
The Phase 1b/2 CARTITUDE-1 study evaluates the safety and efficacy of JNJ-4528, an investigational BCMA-directed CAR-T therapy, in the treatment of patients with relapsed or refractory multiple myeloma. Participants in this study have already tried approved therapies, and had received a median of five prior treatment regimens and their median overall survival is less than 12 months.
MedicalResearch.com: What are the main findings?
Response: Initial findings from the Phase 1b portion of the CARTITUDE-1 study — reported in December at the American Society of Hematology Annual Meeting — showed that JNJ-4528 led to early and deep responses, with 100 percent of patients (n=29) achieving a response at a median six-month follow-up.
The longer-term follow-up results I’ll be presenting at ASCO show that all patients responded to treatment and that the responses were deep and durable, with 86 percent of patients achieving stringent complete response at a median follow-up of 11.5 months, and 86 percent of patients alive and progression free at 9 months. In addition, 97 percent of patients achieved a very good partial response or better, and three percent of patients achieved a partial response. Aside from the well described toxicities associated with CART therapy such as cytokine release syndrome and low blood counts, JNJ4528 was generally well tolerated with no unexpected toxicity.
MedicalResearch.com: What should readers take away from your report?
Response: In short, these longer-term results from the CARTITTUDE-1 study show the continued treatment benefit of JNJ-4528 in heavily pretreated patients who have few or no remaining treatment options. Furthermore, this is accomplished with a one-time treatment without continued dosing or use of maintenance. Patients with multiple myeloma are in need of new options that may provide a durable response and a tolerable safety profile, and that’s what we found in these most recent findings. Encouraging are both the relatively high rate of stringent complete responses, as well as the progression-free survival.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Ultimately, studies will evaluate the initiation of CAR-T in earlier lines of therapy. Most immediately, CARTITUDE-2, a global, multi-cohort Phase 2 study, will investigate JNJ-4528 in patients with multiple myeloma in various clinical settings. That study will evaluate minimal residual disease of participants who receive JNJ-4528. CARTITUDE-4, a global Phase 3 study, will investigate JNJ-4528 in patients who have received only 1-3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug and who are refractory to lenalidomide. That study will evaluate the efficacy of JNJ-4528 compared to standard therapies including daratumumab, pomalidomide and low-dose dexamethasone or pomalidomide, bortezomib and low-dose dexamethasone.
MedicalResearch.com: Is there anything else you would like to add?
Response: In 2020, an estimated 32,270 people will be diagnosed and an estimated 12,830 will die from multiple myeloma in the United States, according to the American Cancer Society. Based on the initial experiences that we’re seeing in relapsed/refractory multiple myeloma, BCMA CAR-T therapies like JNJ-4528 have the potential to transform the treatment of what is today and incurable blood cancer.
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Citation: ASCO 2020 abstract:
Update of CARTITUDE-1: A phase Ib/II study of JNJ-4528, a B-cell maturation antigen (BCMA)-directed CAR-T-cell therapy, in relapsed/refractory multiple myeloma.
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