- Turning Point Therapeutics Inc TPTX has announced additional preliminary data from ongoing trials of lead drug candidate repotrectinib and elzovantinib (TPX-0022).
- The data were presented at the Virtual International Conference on Molecular Targets and Cancer Therapeutics.
- Repotrectinib demonstrated clinical activity across multiple ROS1+ TKI-pretreated NSCLC Cohorts, with confirmed objective response rates (cORR) of 30%-39% in the TRIDENT-1 Study.
- Repotrectinib showed a cORR of 53% in ROS1+ TKI-Pretreated NSCLC Patients with G2032R Solvent Front Mutation.
- At the anticipated meeting with the FDA in 1H of 2022, Turning Point plans to discuss available BICR data in at least 50 patients from the ROS1-positive TKI-pretreated NSCLC cohorts of the study.
- Elzovantinib (TPX-0022) achieved cORR of 36% and 33%, respectively, in MET TKI-Naïve NSCLC and Gastric / Gastroesophageal Junction Cancer Patients Harboring Genetic Alterations in MET in SHIELD-1 Study.
- Related: Turning Point's TPX-0022 In Gastric Cancer Gets Orphan Drug Designation In US.
- For Elzovantinib, based on the FDA feedback, the Company plans to revise SHIELD-1 into a potentially registrational Phase 1/2 study and initiate the Phase 2 portion of SHIELD-1 in 2022, pending FDA feedback on data from the intermediate dose level.
- Price Action: TPTX shares are down 15.3% at $51.42 during the market session on the last check Thursday.
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