Today I’m going to talk about the merge analysis of DREAMM-7 and 8 focusing on functional high-risk patients. Disease response to initial therapy is crucial in identifying prognosis. Functional high-risk is such an identity which is defined as early relapse within 12 months of the stem cell transplant or within 18 months of the initial therapy or diagnosis. And this type of patients constitutes a poor prognosis with the overall survival being less than two years...
Today I’m going to talk about the merge analysis of DREAMM-7 and 8 focusing on functional high-risk patients. Disease response to initial therapy is crucial in identifying prognosis. Functional high-risk is such an identity which is defined as early relapse within 12 months of the stem cell transplant or within 18 months of the initial therapy or diagnosis. And this type of patients constitutes a poor prognosis with the overall survival being less than two years. And this unmet need frequency is claimed to be around 10 to 15 percent but it may be reduced after the introduction of newer induction regimens such as the quadruplets which was as we presented but in the PERSEUS study in the quadruplet arm the functional high risk was three percent compared to six percent in the triplet arm. Nevertheless there are many patients who have not been able to receive this intensive induction regimens. And so how to approach functional high risk has been reported for instance in the CARTITUDE-4 study where in the functional high-risk group, the CAR-T therapy arm had not reached the median for the CAR-T arm in terms of early relapse, but it was in the standard of care only 11 months with a hazard ratio of 0.27. In the KARMMA-2 study, but these are no transplant patients, the two-year progression-free survival was 63% after ide-cel treatment. So during this ASH meeting, we have presented this subgroup analysis focusing on functional high risk and the definition in this study was 18 months from the initial therapy or from the stem cell transplant. This analysis focuses on first-line treatment patients and a total of 250 patients in the DREAMM-7 and 159 patients in DREAMM-8 were included as being after first line of treatment and of these in the DREAMM-7 there were 86 and of DREAMM-8 59 patients who met the criteria for functional high risk. So this is around 34% and 37% of first-line treatment patients. So looking at the progression-free survival in both DREAMM-7 and 8, patients who were not functional high risk achieved better responses compared to functional high risk. But the gap between the functional high risk for the experimental arm was much less compared to the control arm. And the same trend was observed with DREAMM-8 as well. Accordingly, measurable residual disease, duration of response and overall survival were also in favor of the experimental arm, performing better for functional high risk compared to the standard of care. So in conclusion, in this unmet need of patients, we can recommend using either CAR T-cells or bela combinations, which are performing very well, almost similar to what we are observing with CAR T-cells.
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