Thus with a tis.
Top Line: Tisagenlecleucel (aka Kymriah) made huge headlines last year when it became the first FDA-approved CAR-T cell therapy, in that instance for relapsed/refractory ALL in young patients.
The Study: Big news out of ASH 2018 this weekend were the published results of the phase 2 JULIET trial assessing Kymriah’s effectiveness in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Side note: this trial funded by Novartis (the Capulets of this story) comes on the heels of the FDA approval of KITE’s (the Montagues) rival drug Yescarta for this precise indication. 165 patients with relapsed/refractory DLBCL were enrolled, though only 111 (67%) received an infusion...due to the others progressing and/or dying while waiting for their CAR-T cells to be manufactured in Jersey (n=95) or Germany (n=16). It didn't help that the median time from manufacturer receipt of patients’ leukapheresis material to send-back and infusion was 54 days, with some waiting over 3 months. In the end, the primary analysis was performed on 93 patients receiving Jersey CAR-T cells with at at least 3 months follow-up. Among this group, the primary endpoint of overall response was 52% comprised of 40% complete and 12% partial responses.
Bottom Line: Roughly one-third of patients planned to receive CAR-T cells for relapsed/refractory DLBCL achieve a response, and roughly two-thirds of responders are estimated to remain disease-free at 12 months. | Schuster, N Engl J Med 2018
The Study: Big news out of ASH 2018 this weekend were the published results of the phase 2 JULIET trial assessing Kymriah’s effectiveness in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Side note: this trial funded by Novartis (the Capulets of this story) comes on the heels of the FDA approval of KITE’s (the Montagues) rival drug Yescarta for this precise indication. 165 patients with relapsed/refractory DLBCL were enrolled, though only 111 (67%) received an infusion...due to the others progressing and/or dying while waiting for their CAR-T cells to be manufactured in Jersey (n=95) or Germany (n=16). It didn't help that the median time from manufacturer receipt of patients’ leukapheresis material to send-back and infusion was 54 days, with some waiting over 3 months. In the end, the primary analysis was performed on 93 patients receiving Jersey CAR-T cells with at at least 3 months follow-up. Among this group, the primary endpoint of overall response was 52% comprised of 40% complete and 12% partial responses.
Bottom Line: Roughly one-third of patients planned to receive CAR-T cells for relapsed/refractory DLBCL achieve a response, and roughly two-thirds of responders are estimated to remain disease-free at 12 months. | Schuster, N Engl J Med 2018
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