FDA approves label update for Gilead’s Kite for Yescarta to include OS analysis

The company states: “Kite, a Gilead Company, announced that the FDA approved a label update for Yescarta, or axicabtagene ciloleucel, to include the overall survival primary analysis from the landmark Phase 3 ZUMA-7 study showing a statistically significant improvement for Yescarta in OS versus standard of care as second-line treatment with curative intent for patients with relapsed or refractory large B-cell lymphoma within 12 months of completion of first-line therapy. The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS. With an estimated median follow up of 46.7 months overall, the primary analysis of OS showed a statistically significant improvement in the Yescarta arm compared to the standard therapy arm, despite more than half of patients in the SOC arm subsequently receiving cell therapy off protocol. The estimated 39-month OS rates were 55.9% in the Yescarta arm and 46% in the SOC arm. SOC therapy for this patient population has historically been a multi-step process expected to end with stem-cell transplant. The process starts with chemoimmunotherapy, and if a patient responds and can tolerate further treatment, they move on to high-dose chemotherapy, followed by autologous stem cell transplant. Despite this being the prior SOC, less than 40% of patients who started this multi-step process made it through to complete stem cell transplant, compared with 94% of patients randomized to Yescarta in the ZUMA-7 study who received a one-time Yescarta infusion.”