On March 21, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the company has achieved its enrollment target of 40 patients in the EXP-6 cohort of the phase 1/2 registrational TRIDENT-1 study (Press release, Turning Point Therapeutics, MAR 21, 2022, View Source [SID1234610484]). EXP-6 is comprised of NTRK-positive TKI-pretreated advanced solid tumor patients.
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"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," said Athena Countouriotis, M.D., president and chief executive officer. "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."
Enrollment across all six cohorts of the study remains open and continues to progress steadily.
Repotrectinib has been granted Breakthrough Therapy designation for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK tyrosine kinase inhibitors, with or without prior chemotherapy, and have no satisfactory alternative treatments. Repotrectinib has also been granted Fast-Track designation for the treatment of NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments.
Repotrectinib has also been granted Breakthrough Therapy designation in ROS1- positive metastatic NSCLC patients who have not been treated with a ROS1 tyrosine kinase inhibitor, as well as three additional Fast-Track designations in: ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve; ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; and ROS1-positive advanced NSCLC patients pretreated with one prior ROS1 TKI without prior platinum-based chemotherapy.
There are currently no approved targeted therapies for patients with NTRK-positive TKI-pretreated advanced solid tumors.
In a Type B meeting with the United States Food and Drug Administration (FDA) in the fourth quarter of 2021, the FDA noted that data from EXP-5, NTRK-positive patients without prior TRK TKI treatment, may be used to support the efficacy data for EXP-6, or potentially could be pooled with data from EXP-6 to support a broader indication.
The company has previously reported in October 2021 encouraging preliminary data in EXP-6 as of a cutoff date of August 26, 2021, including two responders who confirmed subsequent to the data cutoff date, with a confirmed objective response rate (ORR) of 48% (n=23, 95% CI 27-69%), and within patients with solvent-front mutations, a confirmed ORR of 62% (n=13, 95% CI 32-86%).