So the KarMMa-3 trial is so far the first randomized clinical study that compared a CAR-T, in this case it’s ide-cel, versus a standard of care regimens in a population of patients that had received two to four prior lines of therapy and were all triple-class exposed. So this is an early relapse setting but with a population that are all of them triple-class exposed. So, again, it’s a poor-risk population that needs novel therapies...
So the KarMMa-3 trial is so far the first randomized clinical study that compared a CAR-T, in this case it’s ide-cel, versus a standard of care regimens in a population of patients that had received two to four prior lines of therapy and were all triple-class exposed. So this is an early relapse setting but with a population that are all of them triple-class exposed. So, again, it’s a poor-risk population that needs novel therapies. So the trial is positive. So the treatment with ide-cel prolonged significantly the progression-free survival with a median for patients treated in the ide-cel arm of 13.3 months versus four months in the standard of care regimen arms, and also treatment with ide-cel significantly increased the overall response rate as compared to the standard of care regimens, and patients with ide-cel had an overall response rate of 72% with around 40% of the patients in the standard arm that achieved at least a partial response or better.
So also depth of response or CR and MRD negativity were also more frequent in patients treated with ide-cel, as was the median duration of response. So regarding the safety, overall we can say that the most frequent treatment-related adverse events were hematological and that the safety profile of ide-cel was consistent with previous studies and no new safety signals were observed. No parkinsonism was seen in this study neither. So I think that this is a very important trial, because it’s the first Phase III study that shows progression-free survival advantage for a CAR-T in the setting of early relapse but triple-class exposed relapsed/refractory myeloma patients.