Mounzer Agha, MD, on Main Findings From CARTITUDE Studies at 2021 ASCO


Agha detailed updated findings from CARTITUDE-2 investigating cilta-cel for previously treated patients with multiple myeloma.

CancerNetwork® spoke with Mounzer Agha, MD, of the UPMC Hillman Cancer Center, about findings from the phase 2 CARTITUDE-2 trial (NCT04133636)1 and how the investigation of ciltacabtagene autoleucel (cilta-cel) in patients with multiple myeloma compares with data from CARTITUDE-1.2


CARTITUDE-1 [NCT03548207] showed [extreme] treatment efficacy. Here, we show that the treatment is equally effective and actually quite superior. As you can see from the results that we presented, we have taken patients with 1 to 3 [prior] lines of therapy. If you look at the patient characteristics, they were [mostly] triple-class refractory. Sixty-five percent of the patients were triple-class exposed and 20% were refractory; 40% of patients were penta-drug exposed and 5% were refractory. Sixty percent of patients were refractory to daratumumab [Darzalex] and 85% of the patients had prior autologous stem cell transplant. Although we moved this to an earlier line of therapy, the majority of the patients were refractory to first-line therapy. Ninety-five percent of them were refractory, and 95% of them were exposed to alkylating agents.

Despite that, the overall response was very impressive at 95%. Seventy-five percent were in complete remission and 45% of those were stringent complete remissions. The goal was to see the [minimal residual disease (MRD)] negativity at 10-5. Of all the patients that were MRD valuable at 10-5 at the time of data cutoff, they were all negative. This is very impressive. It’s showing that you have a very high response rate. The responses continue to deepen over time, although we only have a 5.8-month follow-up, but the responses are still ongoing. The point of maximum response we saw on a prior study in CARTITUDE-1 was 9 months. We’re not even there and despite that, we still see an ongoing response rate.

This is extremely encouraging. It actually represents a paradigm shift in the treatment of multiple myeloma. Now we’ve shown for the first time that rather than waiting to apply this very effective therapy in advanced disease, we can start [treating] patients earlier in their disease setting as soon as they show refractoriness to standard therapy.


1. Agha ME, Cohen AD, Madduri D, et al. CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma (MM) after one to three prior lines of therapy. J Clin Oncol. 2021;39(suppl 15):8013. doi:10.1200/JCO.2021.39.15_suppl.8013

2. Usmani SZ, Berdeja JG, Madduri D, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1. J Clin Oncol. 2021,39(suppl 15).8005. doi:10.1200/JCO.2021.39.15_suppl.8005

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