IMW 2021 | Results from the CARTITUDE-2 trial
Hermann Einsele, MD, FRCP, of the University of Würzburg, Würzburg, Germany, discusses updated results from the CARTITUDE-2 study (NCT04133636), a Phase II study investigating the efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of patients with multiple myeloma. Prof. Einsele comments on the findings of the CARTITUDE-1 trial (NCT03548207), which reported an 80% complete remission rate, and describes how risk assessment and early monitoring for neurotoxicity was incorporated into the CARTITUDE-2 trial. This interview took place during the 18th International Myeloma Workshop (IMW 2021) congress.
Transcript (edited for clarity)
The CARTITUDE-2 trial is a trial in which the cilta-cel, which is a CAR T-cell product, actually targeting BCMA with two binding domains, is being used in earlier lines of therapy. And so, in the CARTITUDE-1 trial, it could all be already be shown that this CAR T-cell product is extremely effective. So, we have seen very high overall response rate of nearly 100%, 80% complete remission. And the same was now also confirmed with the CARTITUDE-2 trial...
The CARTITUDE-2 trial is a trial in which the cilta-cel, which is a CAR T-cell product, actually targeting BCMA with two binding domains, is being used in earlier lines of therapy. And so, in the CARTITUDE-1 trial, it could all be already be shown that this CAR T-cell product is extremely effective. So, we have seen very high overall response rate of nearly 100%, 80% complete remission. And the same was now also confirmed with the CARTITUDE-2 trial.
What has been done in addition to the CARTITUDE-1 trial, is to – because of the CARTITUDE-1 trial, there was some late form of neurotoxicity – was to introduce a kind of risk assessment and early monitoring for neurotoxicity.
So, what they found from the data from the CARTITUDE-1 trial is that patients that had a high tumor load, that had a CRS or ICANS before, then had a high CAR T-cell expansion and good CAR T-cell persistence, that these were the patients that were at a high risk of developing this late neurotoxicity.
And so, the bridging therapy was intensified to reduce the tumor load at the time of CAR T-cell infusion. And in addition, this monitoring for early signs of neurotoxicity was introduced and especially using handwriting analysis and also other means to screen for neurotoxicity. And with both, with this risk assessment with the more intensified bridging therapy and with the early monitoring for neurotoxicity, this late-onset neurotoxicity with neurocognitive or Parkinsonian-like syndromes was completely abolished or prevented in the CARTITUDE-2 trial.
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