Turning Point Reveals Early Repotrectinib Data In NTRK+ Advanced Solid Tumors

Turning Point Therapeutics Inc TPTX announced early data from TRIDENT-1 Phase 1/2 study of its lead drug candidate repotrectinib.
In the NTRK-positive TKI-naïve advanced solid tumor population (n=17), the confirmed Objective Response Rate (cORR) was 41%.
Three patients with limited time on treatment achieved stable disease with tumor regression of -21%, -23%, and -27% on their first post-baseline scans.
In the NTRK-positive TKI-pretreated advanced solid tumor population (n=23), the cORR was 48%. Three patients had unconfirmed partial responses (uPRs).
Two uPRs have been confirmed since the cutoff date and are included in the cORR; the third patient with a uPR was on treatment awaiting a confirmatory scan.
In 13 NTRK-positive TKI-pretreated patients with NTRK solvent front mutations, the cORR was 62%, including one patient who had a complete response.
In preliminary safety analysis (n=301), repotrectinib was generally well tolerated.
The most frequently reported treatment-emergent adverse event was low-grade dizziness (60%), (4%) ataxia in the absence of dizziness.
No events of dizziness or ataxia led to treatment discontinuation.
Related: Turning Point Shares Plunge After Highlighting Updated Data From Lead Program In Pretreated Lung Cancer Patients.
The Company is looking forward to a Type B meeting with the FDA anticipated in 1H of 2022.
Price Action: TPTX shares are up 0.79% at $46.92 during the market session on the last check Friday.