ASH 2024 | MRD negativity in the CARTITUDE-4 trial: cilta-cel vs SoC in lenalidomide-refractory myeloma

CARTITUDE-4 was a Phase III clinical trial evaluating the role of cilta-cel, which is a BCMA-targeted CAR T-cell versus standard of care options which were daratumumab, pomalidomide, dexamethasone or pomalidomide, Velcade, dexamethasone. We previously demonstrated that cilta-cel demonstrated a significant improvement in both progression-free survival and indeed overall survival and is the only myeloma CAR T-cell so far that has shown this improvement in overall survival. What we’re showing here are the MRD negativity rates for this study. What we demonstrate is that patients were more likely to achieve MRD negativity overall with cilta-cel compared to standard of care and this is approximately a three-fold increase in MRD negativity. But what was very interesting was that when you look at the 10 to the minus 6 level which is much more deeper than the 10 to the minus 5 standard level, almost all the patients who achieved MRD negativity for cilta-cel at 10 to the minus 5 also achieved it at 10 to the minus 6. However, when you look at the standard of care arm, very few patients achieved MRD negativity at 10 to the minus 6. Now, when we also look at the attainment of MRD negative CR rates, then again, more patients achieved MRD negativity CR for cilta-cel compared to standard of care. And then if we go on and look at the achievement of sustained MRD negativity, which is achieving MRD negative results for two occasions at least more than 12 months apart, you’re more likely to achieve that with cilta-cel compared to standard of care. And then that correlates with an improvement in both progression-free survival and indeed overall survival. And then finally, we looked at some biological correlates, and you find that the patients who are more likely to achieve MRD negative CR were those patients who had a lower inflammatory phenotype, who had a better T-cell phenotype at the time of apheresis. We also saw higher T-cell expansion and we didn’t see a negative impact on soluble BCMA. So overall when you put all this together this supports the use of cilta-cel at early relapse where we have higher levels of deep MRD negativity which corresponds to the improvement in both progression-free survival and overall survival.

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