After 5 Years of No CR MRD with Cilta-Cel, No Maintenance Required

According to Sundar Jagannath, MBBS, the cure for multiple myeloma has been observed in the 12 patients who participated in the phase 1b/2 CARTITUDE-1 trial who were found to be cancer-free for 5 years following a single dose of ciltacabtagene autoleucel (cilta-cel; Carvykti).

At the Society of Hematologic Oncology 2025 Annual Meeting, Jagannath, a professor of medicine specializing in hematology and medical oncology at the Icahn School of Medicine at Mount Sinai and The Tisch Cancer Institute, spoke with CancerNetwork® following his presentation titled, “Is It Time to Say ‘CURE’ in Multiple Myeloma?”.

He emphasized that in CARTITUDE-1, 32 of 37 patients were alive and progression-free for at least 5 years following treatment with a single dose of cilta-cel. Notably, in the trial, the median overall survival was 60.7 months (95% CI, 41.9-not estimable). As all the patients enrolled in the trial had heavily pretreated relapsed/refractory multiple myeloma, Jagannath added that results for patients with newly diagnosed disease will be better.

“We found that patients who are [in a complete remission], MRD-negative, and PET/CT negative year after year for 5 years don’t have to be maintained. Thereafter, they are cured,” said Jagannath.

Transcript:

There was a presentation this year at ASCO and EHA, as well as a publication in the Journal of Clinical Oncology on the results of cilta-cel in a phase 1b/2 trial. Results were from 2018 and 2019, with the 5-year readout. What was amazing is that these patients, when they participated in the clinical trial, had traditionally relapsed/refractory multiple myeloma. At that time, they were an unmet medical need—that means either you participate in the clinical trial or you’re looking at hospice. What was surprising was that 97 patients participated in the clinical trial, and after a median follow-up of 5 years or 61 months, one-third of the patients, or 32 patients, were alive and progression-free. Twelve of these patients who participated in the trial were studied every year with MRD for minimal residual disease with bone marrow blood tests and PET/CT annually, and they were found to be cancer-free year after year for 5 years. That is the definition of a cure without any maintenance.

We [finally] have a treatment modality on a clinical trial, with multiple institutions participating and accelerated approval given by the FDA, where the long-term results show that one-third of the patients were alive and progression-free in a relapsed/refractory situation. That means potentially curing patients in the end stage. If you offer such treatment options earlier in the disease course, then you will get better results, and there have been clinical trials to support that.

Then we also looked at the results, which have been published. We had reported our results of studying patients with annual bone marrow for MRD blood test and PET/CT done. We found that patients who are [complete remission] MRD-negative, and PET/CT negative year after year for 5 years don’t have to be maintained. Thereafter, they are cured. We found that not only half of the patients had newly diagnosed multiple myeloma, but almost 40% of the patients were in second relapse or third and subsequent relapse, clearly proving that the cure definition we established holds true, not only for [patients with] newly diagnosed myeloma, but even in relapsed situations. So that’s very important.

References

Jagannath S, Martin TG, Lin Y, et al. Long-term (≥5-Year) remission and survival after treatment with ciltacabtagene autoleucel in CARTITUDE-1 patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2025;43(25):2766-2771. doi:10.1200/JCO-25-00760