Gilead's Kite Unveils More Data On Yescarta In Second-Line Lymphoma Patients

Kite Pharma, a Gilead Science Inc's Company (NASDAQ: GILD), announced primary analysis results from the ZUMA-7 Phase 3 trial of Yescarta (axicabtagene ciloleucel) as a one-time infusion.

  • The head-to-head study evaluated Yescarta against standard of care (SOC) for adults with large B-cell lymphoma (LBCL) who relapsed or were refractory to first-line treatment.
  • With a median follow-up of over two years, the study met the primary endpoint of event-free survival. 
  • Yescarta demonstrated a 2.5 fold increase in alive patients at two years and did not require additional cancer treatment or experienced cancer progression (40.5% vs. 16.3%).
  • In terms of median EFS, Yescarta patients hit 8.3 months at a two-year check-in compared with two months for SOC, which includes salvage chemoimmunotherapy followed by a high dose of chemo and eventually an autologous stem cell transplant. 
  • At two years, 40.5% of patients dosed with Yescarta were still alive compared with 16.3% on SOC.
  • Meanwhile, patients randomized to the Yescarta arm posted an 83% overall response rate and a complete response rate of 65%. Patients on SOC posted rates of 50% and 32%, respectively. 
  • Median OS was not reached at the time of data cutoff.
  • Kite Pharma also posted five-year follow-up data from the ZUMA-1 trial of Yescarta. The five-year overall survival (OS) rate was 42.6%.
  • Among patients with a complete response (CR), the five-year OS rate was 64.4%, and the median survival time was not reached. 
  • Among treated patients alive at five years, 92% have received no additional treatment since their one-time infusion of Yescarta, suggestive of a cure for these patients. 
  • Price Action: GILD shares are down 0.04% at $70.22 during the premarket session on Monday's last check.
  • Check out our coverage of the American Society of Hematology (ASH) Annual Meeting 2021 here.
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