The study was designed to evaluate the use of ciltacabtagene autoleucel in patients with relapsed or refractory multiple myeloma in the United States.
Preliminary data from the phase 1b/2 CARTITUDE-1 trial (NCT03548207) indicated that a single low-dose infusion of ciltacabtagene autoleucel (cilta-cel; JNJ-68284528; LCAR-B38M CAR-T cells) resulted in early, deep, and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma, with a safety profile consistent with that observed in the phase 1 LEGEND-2 trial (NCT03090659).
In an interview with CancerNetwork®, Deepu Madduri, MD, assistant professor of Medicine (Hematology and Medical Oncology), associate director of Cellular Therapy Service, and director of Clinical Operations with the Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai, spoke about the results of the trial.
So, now, let’s talk about a little bit about the results and the efficacy of the study. The overall response rate on this study was 96.9%, with 67% of the patients actually achieving stringent [complete response] CR [complete response], and 93% of these patients achieving [very good partial response] VGPR [very good partial response] or better. We saw how heavily pretreated these patients were and to see a one-time treatment give these kinds of response rates is quite exceptional. What’s even more impressive is that 72% of these patients are still maintaining their response at the time of data cut off. Additionally, we also looked at the overall [minimal residual disease] MRD [minimal residual disease]–negativity rate in patients that who are evaluable. That rate was 93% with 58% of the evaluable patients having MRD negativity and being in stringent CR.
Another interesting thing is we know based on the MAMMOTH study, patients with relapsed and [CD38-]refractory myeloma have a median overall survival of only 9.2 months [if they were] triple refractory and only 5.6 months [with] penta-refractory [disease].
In this [CARTITUDE-1] study, we know that the median [progression-free survival] PFS is at least a full year. We still haven’t even reached a median PFS after a median duration of follow up of 12.4 months. We also broke the PFS down by response and the 12-month PFS [rate] in patients who achieved CR or better was 85%; and then the 12-month PFS [rate] in patients with VGPR or better was 68%. Once again, the median PFS was not reached in either group. And finally, the overall survival, even though it does take a little bit of time, we did look at the 12-month overall survival rate on this study and it was 88.5%. And again, the median overall survival was not reached.