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Thursday, April 25, 2024

ImmunityBio Positive Overall Survival Results of Combo inl Lung Cancer; Set to Meet with FDA

 

  • QUILT 3.055 trial completed and shows median overall survival almost double that of standard of care chemotherapy in 2nd- and 3rd-line non-small cell lung cancer (NSCLC) patients whose cancer did not respond to checkpoint inhibitors with or without chemotherapy
  • Positive results seen in both PD-L1 negative and PD-L1 positive participants with NSCLC
  • Data reaffirms the mechanism of action of ANKTIVA as an immune cell enhancer that activates natural killer (NK) cells and memory T cells to rescue checkpoint inhibitor (pembrolizumab, nivolumab, atezolizumab) failures across multiple tumor types
  • Meeting scheduled with FDA in June to discuss path to registration filing of ANKTIVA plus checkpoint inhibitors in 2nd- and 3rd-line NSCLC patients whose cancer previously did not respond to checkpoint therapy
  • $100 million in non-dilutive cash infusion with ANKTIVA approval brings cash-on-hand to approximately $240 million for launch of ANKTIVA in non-muscle invasive bladder cancer (NMIBC)
  • Company has scheduled a conference call to discuss registration plans for NSCLC, status of ANKTIVA launch readiness for NMIBC, and ANKTIVA as the backbone of our clinical trial pipeline for multiple tumor types

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