ASH 2021 | Latest results from the CARTITUDE-2 trial of cilta-cel in progressive multiple myeloma
Hermann Einsele, MD, FRCP, University of Würzburg, Würzburg, Germany, shares the latest findings from the Phase II CARTITUDE-2 trial (NCT04133636) of ciltacabtagene autoleucel (cilta-cel) in lenalidomide-refractory patients with progressive multiple myeloma after 1-3 prior lines of therapy. Results from the Phase Ib/II CARTITUDE-1 clinical trial (NCT03548207) revealed deep and durable responses to cilta-cel in patients who had received ≥3 prior lines of therapy. Given these findings, CARTITUDE-2 aimed to assess the impact of bringing cilta-cel forward to earlier lines of therapy. At the time of data cut-off, 20 patients with a median of 2 prior lines had received cilta-cel. The overall response rate was 95%, with 85% reaching complete response (CR) or better. The median time to best response was 3.3 months. Notably, no additional toxicity was seen compared to what was seen in CARTITUDE-1. Cytokine release syndrome (CRS) was mostly low grade and manageable and no movement or neurocognitive treatment emergent adverse events were observed. Follow-up is ongoing. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.
Transcript (edited for clarity)
This bit concerns a study using BCMA-directed CAR-T cell product cilta-cel for relapsed/refractory multiple myeloma. Now in the CARTITUDE-1 trial, the overall response rate was nearly 100%, and a CR rate of 80%. And the progression-free survival is now approaching two years with a very acceptable CRS, and with also using a new mitigation strategy, also an acceptable neurotoxicity.
So the idea was now to move these very effective BCMA-directed CAR-T cell products to earlier lines of therapy...
This bit concerns a study using BCMA-directed CAR-T cell product cilta-cel for relapsed/refractory multiple myeloma. Now in the CARTITUDE-1 trial, the overall response rate was nearly 100%, and a CR rate of 80%. And the progression-free survival is now approaching two years with a very acceptable CRS, and with also using a new mitigation strategy, also an acceptable neurotoxicity.
So the idea was now to move these very effective BCMA-directed CAR-T cell products to earlier lines of therapy. And 20 patients were actually included. And the good thing that was really noticed is that there was no additional toxicity. We all were afraid if we were to take the T-cells earlier, at an earlier stage, more effective, more active T-cells, we might see more toxicity. And that was actually not the case. And there was no late-onset neurotoxicity that was seen in the few patients in the CARTITUDE-1 trial.
So this was very reassuring, and at the same time, also, the response rate was quite similar. Maybe we would have expected a bit more overall response, more complete remissions, but due to the small number of patients and also a short follow-up, actually it couldn’t be shown yet that early application of cilta-cel was much more effective than in the late stage disease.
There are two things. At the moment, several studies are looking at earlier therapy. So even going into first-line therapy and high risk patients’ first relapse. And there’s actually a study that is planned for maybe studying next, or 2023, when actually autologous stem cell transplantation is challenged by CAR-T cell therapy. And then we will really seek to better define the role of CAR-T cell therapy in the whole spectrum of anti-myeloma treatments that are available now.
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