Transcenta Announces Orphan Drug Designation Granted to TST001 for Treatment of Gastric and Gastroesophageal Junction
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SUZHOU, China, July 28, 2021 /PRNewswire/ Transcenta Holding Limited ( Transcenta ), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TST001, its anti-Claudin18.2 monoclonal antibody currently in Phase I clinical trial, for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ). According to preclinical and clinical data, TST001 displayed potent anti-tumor activities in tumor model of gastric cancer or patient of gastric cancer expressing Claudin18.2.
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At final analysis, study showed clinically relevant improvement in median overall survival with a difference of 11.7 months between arms (Hazard ratio (HR): 0.84 with 95% CI: (0.60, 1.17) (p=0.30
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EAST HANOVER, N.J., June 3, 2021 /PRNewswire/ Novartis today reported the final analysis from the NETTER-1 phase III study comparing treatment using Lutathera
® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors. The previously reported primary analysis of the trial demonstrated a statistically significant improvement in progression free survival (PFS) (HR: 0.18 , p 0.0001)
3. In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months [48.0 months (95%CI: 37.4-55.2) compared to the control arm (36.3 months (95%CI: 25.9-51.7)]