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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.
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- 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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