Turning Point Therapeutics, Inc. announced receipt of positive feedback from the FDA at a pre-NDA meeting completed during the second quarter. The feedback focused on the proposed patient follow-up within the ROS1-positive advanced NSCLC patient cohorts of the ongoing TRIDENT-1 registrational study. The purpose of the pre-NDA meeting was to discuss the company's planned NDA for repotrectinib for the treatment of ROS1+ advanced NSCLC.

The FDA agreed with the company's plan to provide data for ROS1+ TKI-naïve and TKI-pretreated advanced NSCLC patients with at least six months of follow-up from the first post-baseline scan at the time of NDA submission. Received Breakthrough Therapy designation (BTD) from the FDA for repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with one ROS1 tyrosine kinase inhibitor and who have not received prior platinum-based chemotherapy. This represents the eighth regulatory designation granted by the FDA for repotrectinib.

ELZOVANTINIB: Initiated the Phase 1b/2 SHIELD-2 combination study of elzovantinib and aumolertinib in EGFR mutant MET-amplified advanced non-small cell lung cancer. The combination of elzovantinib and aumolertinib is being studied in patients with EGFR mutant MET-amplified advanced NSCLC who have progressed following treatment with osimertinib. The study will evaluate the safety, tolerability and preliminary efficacy of the combination regimen.

Initiated patient dosing in the third dosing level cohort in the Phase 1 study of TPX-4589. TPX-4589 is a potentially first-in-class anti-Claudin18.2 antibody drug conjugate (ADC) that suppresses cell proliferation of gastric and pancreatic cell lines with nanomolar potency in preclinical models. It is currently being studied in two ongoing Phase 1 studies in patients with advanced solid tumors.

Upcoming Milestones: REPOTRECTINIB: Present detailed study results, including intracranial activity, from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study at a medical conference in the second half of 2022. Provide a clinical data update from the NTRK+ advanced solid tumor cohorts from TRIDENT-1 in the second half of 2022. ELZOVANTINIB: Initiate the Phase 2 portion of the SHIELD-1 study in the second half of 2022, pending FDA feedback on data from the intermediate dose level.

Provide a clinical data update from the Phase 1 SHIELD-1 study in the second half of 2022. TPX-0131: Provide early interim data from initial patients treated in the dose-finding portion of the FORGE-1 study in the fourth quarter of 2022 or early 2023. TPX-4589: Present preclinical data at a medical conference by early 2023.

Provide additional guidance on clinical development plan by early 2023. DISCOVERY: Nominate 2 development candidates in the second half of 2022. Provide details on the other 2 GTPase signaling discovery programs in the second half of 2022.