Preliminary data from ZUMA-3 announced earlier this month showed that 73% of the patients achieved CR.
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A phase Ib/II combination study (ZUMA-6) evaluating axicabtagene ciloleucel plus Roche Holding AG’s RHHBY Tecentriq (atezolizumab) in patients with chemorefractory DLBCL commenced in Oct 2016Ī number of key data readouts are expected in 2017, which should keep investors glued to the stock. In the first quarter, Kite Pharma initiated ZUMA-5 study in patients with follicular NHL and ZUMA-9 to provide patients access to axicabtagene ciloleucel during the regulatory review period.
Kite Pharma is also evaluating axicabtagene ciloleucel in a phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and in two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL) – ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL. Meanwhile other studies with axicabtagene ciloleucel are also advancing. We believe that the solid efficacy profile demonstrated by the pivotal ZUMA-1 study should support the drug’s approval this year. Ongoing analysis demonstrated that axicabtagene ciloleucel’s efficacy was stable with 44% ORR and 39% CR. Previously, top-line data announced in February from the study showed that at month 6, after axicabtagene ciloleucel treatment, 41% of the patients achieved a response, including 36% achieving a complete response (CR). The study met the primary endpoint of objective response rate, or ORR, recorded after a single infusion of axicabtagene ciloleucel, with 82%.
In April, Kite Pharma presented detailed data from this study at the annual meeting of the American Association of Cancer Research (AACR).
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