- Turning Point Therapeutics (NASDAQ:TPTX) reports initial clinical data from the ongoing Phase 1 dose finding portion of its SHIELD-1 study of TPX-0022, a potent inhibitor of MET and the associated cancer signaling pathways of SRC and CSF1R.
- The initial data highlighted preliminary clinical activity, including objective responses across multiple tumor types and were presented at 2020 EORTC-NCI-AACR Symposium. The data cut-off date was October 15, 2020.
- A total of 22 patients with MET-dysregulated advanced solid tumors were treated with TPX-0022 at dose levels from 20 mg once daily (QD) to 120 mg QD.
- TPX-0022 was generally well-tolerated, with the most frequent treatment emergent adverse event being Grade 1 or 2 dizziness. The maximum tolerated dose had not been determined.
- Pharmacokinetic data suggested sustained MET inhibition throughout the dosing interval across all doses.
- Nine of 15 patients (9/15) evaluable for efficacy achieved clinical benefit (confirmed and unconfirmed partial response or stable disease).
- Six of 15 patients (6/15) remained on treatment, with duration of treatment ranging from 7.6+ to 34+ weeks.
- The company anticipates initiating Phase 1 dose expansion after determining the recommended Phase 2 dose.
- Turning Point plans to discuss the ongoing Phase 1 SHIELD-1 study with the FDA to potentially modify the trial into a registrational Phase 1/2 design. Phase 2 portion is expected to be initiated in H2, pending FDA feedback.
- In addition, preclinical data for the company’s lead drug candidate, repotrectinib, were also reported in two poster presentations.
- In the first poster presented, repotrectinib significantly enhanced efficacy of AMG-510 and showed a marked survival benefit in a KRAS G12C xenograft model when compared to AMG-510 alone.
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Monday, October 26, 2020
Turning Point's TPX-0022 shows encouraging action in MET-driven cancers
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