Yes, so at this ASH meeting on Monday, we have an oral presentation exploring the risk of infections in patients receiving bispecifics in monotherapy in the relapsed/refractory setting for large B-cell lymphoma compared to patients who are receiving CAR T-cell therapy in the relapsed/refractory setting for large B-cell lymphoma. These are CD19-targeted CAR T-cells and mainly CD20xCD3-targeted bispecifics...
Yes, so at this ASH meeting on Monday, we have an oral presentation exploring the risk of infections in patients receiving bispecifics in monotherapy in the relapsed/refractory setting for large B-cell lymphoma compared to patients who are receiving CAR T-cell therapy in the relapsed/refractory setting for large B-cell lymphoma. These are CD19-targeted CAR T-cells and mainly CD20xCD3-targeted bispecifics.
So we have approximately 160 CAR T-cell recipients and 140 bispecific recipients. And in terms of their baseline variables, we observed an older age, a higher rate of poor performance status, and, you know, IPI score in the bispecific recipients. And in terms of other, you know, important efficacy outcomes, patients who received CAR T-cell therapy did have a higher CR rate and a prolonged PFS compared to bispecific recipients. Conversely, there was a higher incidence of ICANS in CAR T-cell recipients, as is expected, CAR T-cell recipients, compared to bispecifics, and therefore a higher use of steroids with CAR-T. So higher efficacy, but higher incidence of ICANS and steroid use with CAR T-cells.
That said, when we looked at our primary endpoint of cumulative incidence of grade three or higher infections, we observed similar numbers in the bispecific and the CAR T-cell group. And when we accounted for different variables in the multivariate analysis, the only one that stood out was the dose of steroids that the patients had received after treatment for adverse event management. So that significantly increased the risk of experiencing an infection and a grade three or higher infection.
So we observed, in conclusion, a similar cumulative incidence of any grade and grade 3 or higher infections between the bispecific recipients and the CAR T-cell recipients. Steroids definitely stood out as the main risk factor for infections. And interestingly, we also looked at dual-exposed patients, patients exposed to both CAR T-cells and bispecifics, and observed a similar risk of infections in these patients compared to those only receiving CAR T-cells or only receiving bispecifics.
Finally, we also performed a COVID-free analysis, excluding COVID-19 infections, and the results were the same. As we mentioned, mainly bacterial and viral infections, mainly respiratory infections, and in terms of mortality associated with the infections, that was 5% in both bispecifics and CAR T-cell patients. So that was the conclusion of our abstract, similar rate of infections in both groups, and steroids being the main risk factor for infections.
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