Turning Point Reveals Topline Data From Pivotal Repotrectinib Trial In Lung Cancer Setting

Turning Point Therapeutics Inc TPTX announced topline results from the registrational TRIDENT-1 study of repotrectinib across all four ROS1-positive advanced non-small cell lung cancer (NSCLC) cohorts.

• In a total of 71 TKI-naïve advanced NSCLC population, the confirmed objective response rate (cORR) was 79%, with 4 patients (6%) achieving a complete response (CR) and 52 patients (73%) achieving a partial response (PR). 
• The cORR does not include one patient in an unconfirmed partial response (uPR) with tumor regression of -38% on the last scan, who remained on treatment awaiting the following scan as of the data cutoff date.
• In the TKI-naïve population with approximately 10 months of follow-up, initial estimated durability of response and progression-free survival of 85% and 82% at 12-month landmarks, respectively.
• Related: FDA Clears Turning Point's IND For Elzovantinib + Aumolertinib Combo Regime In Lung Cancer Setting.
• In TKI-pretreated patients, cORR of 42% in those treated with 1 TKI and platinum-based chemotherapy (EXP-2), cORR of 28% in those treated with two TKIs (EXP-3), and cORR of 36% in those treated with 1 TKI (EXP-4) were observed.
• Repotrectinib was generally well-tolerated. The most commonly reported treatment-emergent adverse event remained dizziness, of which 76% of patients reported mild dizziness. 
• The safety profile was comparable among the 287 patients treated at the Phase 2 dose.
• Price Action: TPTX shares closed 2.38% lower at $24.20 during after-hours trading on Tuesday.