Oscar season.
Top Line: Novartis recently secured critically-acclaimed headlines with the publication of the JULIET trial reporting victories with the anti-CD19 CAR T-cell line Kymriah for refractory diffuse large B-cell lymphoma (DLBCL).
The Study: Prior to the year end, KITE squeaked out the longest follow-up to date with its extended results with Yescarta in the ZUMA-1 trial. Remember, axicabtagene ciloleucel (aka Yescarta, thank goodness) was the first CAR T-cell iteration to win FDA approval for DLBCL. ZUMA-1 had a phase 1/2 design and enrolled 119 patients with refractory DLBCL or primary mediastinal B-cell lymphoma. Unlike JULIET, patients were “enrolled” only after CAR T-cells were manufactured. And here they were deemed “assessable for activity” only after CAR-T cell infusion in the phase 2 component (n=101). With these caveats, the primary endpoint of overall response rate per investigator was 83% (58% complete + 25% partial). Median duration of response was 11 months, though overall progression-free survival was just shy of 6 months. In other sobering news, one-third of patients experienced at least grade 3 neurologic toxicity. This is not to diminish the fact that, at a median follow-up of over 27 months, 37 of these otherwise incurable patients were still enjoying a complete response—scooting the projected median survival to over 24 months.
Bottom Line: Like Kymriah, Yescarta achieves a durable response in a minority of patients with refractory DLBCL but still represents a laudable advancement in a disease previously without options. | Locke, Lancet Oncol 2018
The Study: Prior to the year end, KITE squeaked out the longest follow-up to date with its extended results with Yescarta in the ZUMA-1 trial. Remember, axicabtagene ciloleucel (aka Yescarta, thank goodness) was the first CAR T-cell iteration to win FDA approval for DLBCL. ZUMA-1 had a phase 1/2 design and enrolled 119 patients with refractory DLBCL or primary mediastinal B-cell lymphoma. Unlike JULIET, patients were “enrolled” only after CAR T-cells were manufactured. And here they were deemed “assessable for activity” only after CAR-T cell infusion in the phase 2 component (n=101). With these caveats, the primary endpoint of overall response rate per investigator was 83% (58% complete + 25% partial). Median duration of response was 11 months, though overall progression-free survival was just shy of 6 months. In other sobering news, one-third of patients experienced at least grade 3 neurologic toxicity. This is not to diminish the fact that, at a median follow-up of over 27 months, 37 of these otherwise incurable patients were still enjoying a complete response—scooting the projected median survival to over 24 months.
Bottom Line: Like Kymriah, Yescarta achieves a durable response in a minority of patients with refractory DLBCL but still represents a laudable advancement in a disease previously without options. | Locke, Lancet Oncol 2018
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