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Heat Biologics Cell Therapy Shows Survival Benefit In Mid-Stage Lung Cancer Study, Shares Rally

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  • Heat Biologics Inc (NASDAQ: HTBX) soars in premarket on the heels of encouraging interim data from the Phase 2 trial evaluating HS-110, in combination with Bristol-Myers Squibb's (NYSE: BMY) Opdivo (nivolumab) in advanced non-small-cell lung cancer (NSCLC).
  • Median progression-free survival (PFS) of 1.8 months and median overall survival (OS) of 24.6 months was observed in checkpoint inhibitor naïve patients with advanced NSCLC (cohort A, N = 47).
  • The one-year survival rate of Cohort A is 61.7%. The median OS data was 12.2 months, and the 1-year survival rate was 50.7% in previously treated, advanced NSCLC patients who received nivolumab as a single agent, according to published data of the CheckMate 057 study1.
  • For NSCLC patients who had previously been treated with a checkpoint inhibitor and whose disease had subsequently progressed (Cohort B, N = 68), a median PFS of 2.8 months and median OS of 11.9 months was observed.
  • As of this data cut, 30% of the patients in Cohort A and 26% of Cohort B patients are still alive. HS-110 showed a favorable safety profile and has been administered in approximately 200 patients to date. No treatment-related serious adverse reactions were reported.
  • HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients' immune system against multiple cancer-testis antigens to elicit a diverse and robust immune response against tumor cells.
  • Price Action: HTBX gained almost 80% to $15.1 during the premarket session on the last check Tuesday.
 

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Posted-In: Non-Small Cell Lung Cancer Phase 2Biotech News FDA Top Stories General

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