Turning Point Therapeutics Inc. (NASDAQ: TPTX) has announced the attainment of its recruitment target of 40 subjects in the EXP-6 cohort of the Phase 1/2 registration TRIDENT-1 study. EXP-6 comprises of NTRK+ TKI-pretreated advanced solid tumor patients.
Turning Point completes enrolment in TRIDENT-1 study
CEO Athena Countouriotis said, “I am incredibly proud of our team as we have completed enrollment of the NTRK-positive TKI-pretreated EXP-6 cohort ahead of our internal projections, driven by another strong quarter of enrollment in the TRIDENT-1 study. Separately we remain on track to provide our top line data across ROS1-positive TKI-naïve and TKI-pretreated NSCLC cohorts and to conduct our first pre-NDA meeting for repotrectinib, both anticipated in the second quarter of 2022. We will now begin preparations for our second repotrectinib pre-NDA meeting to discuss the NTRK-positive population, which we anticipate will take place in the first quarter of 2023.”
Registration in all six study cohorts is still open and progressing steadilRepotrectinib has been designated as a Breakthrough Therapy for the treatment of advanced solid tumors patients with an NTRK fusion protein who have progressed after therapy with one or two previous TRK tyrosine kinase inhibitors, without or with previous chemotherapy, and who have no acceptable treatment options.
Also, Repotrectinib has been granted Fast-Track designation for NTRK-positive individuals with advanced solid tumor cells, which have progressed after at least one previous chemotherapy line and one or two preceding TRK TKIs and do not have satisfactory treatment options.
No available approved targeted treatments for NTRK+ advanced solid tumors
Currently, there are no authorized targeted treatments for individuals with advanced solid tumors that are NTRK-positive and have been treated with TKIs.
In a Type B session with the US FDA in Q4 2021, the FDA stated that data from EXP-5, NTRK-positive sick people who had not previously received TRK TKI treatment, could be used to endorse the efficacy findings for EXP-6, or possibly could be grouped with results from EXP-6 to endorse a broader indication. In October 2021, the Company announced encouraging interim data in EXP-6 as of the August 26 2021cutoff date.
