Turning Point's RET Inhibitor Candidate Shows Tolerable Safety Profile, Early Signals Of Activity In Solid Tumor Settings

Turning Point Therapeutics Inc TPTX has reported initial data from the ongoing Phase 1/2 SWORD-1 study evaluating its RET inhibitor drug candidate, TPX-0046, in adult subjects with advanced or metastatic solid tumors harboring RET mutations or alterations.
Data from the Phase 1 dose-finding portion of the study showed preliminary clinical activity, including objective responses and a generally well-tolerated safety profile.
TPX-0046 was generally well tolerated, with the most frequent treatment-emergent adverse event being mild to moderate dizziness.
The maximum tolerated dose had not been determined, with one dose-limiting toxicity of treatment-related moderate gait disturbance at 30 mg dose.
Of five RET TKI-naïve patients, four showed tumor regressions of -42%, -37%, -23%, and -3%, including two patients dosed at 30 mg who achieved confirmed partial responses with a duration of responses of 5.6 and 5.8+ months, respectively.
Of 9 TKI-pretreated patients, three patients achieved tumor regressions of -44%, -27%, and -17%.
The company also plans to revise the study protocol to include Phase 1 expansion cohorts in up to 75 patients with RET-altered malignancies.
Price Action: TPTX shares are trading 0.50% lower at $89.50 in the premarket session on the last check Tuesday.