On December 20, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported regulatory updates for its lead drug candidate, repotrectinib, a ROS1/TRK Inhibitor, and for elzovantinib (TPX-0022), its drug candidate targeting MET, CSF1R and SRC (Press release, Turning Point Therapeutics, DEC 20, 2021, View Source [SID1234597483]). These updates follow FDA meetings held earlier in December .

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REPOTRECTINIB, ROS1/TRK INHIBITOR

Based on the breakthrough therapy designation granted by the FDA earlier this quarter, the company participated in a Type B meeting with the FDA to discuss potential next steps for repotrectinib in NTRK-positive TKI-pretreated advanced solid tumor patients treated within expansion cohort 6 (EXP-6) of the registrational TRIDENT-1 study.

The FDA guided that a pre-NDA meeting should be requested to discuss the topline blinded independent central review (BICR) results from the Phase 2 TKI-pretreated EXP-6 and TKI-naïve EXP-5 patients, when responders have been followed for at least six months past onset of response. The FDA also acknowledged the company’s plan to submit to the pre-NDA meeting, BICR data from 40 patients from EXP-6 and BICR data from patients enrolled in EXP-5 cohort at that time (estimated at approximately 40 patients of the targeted 55 patients). The FDA noted that data from EXP-5 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 FDA stated that whether the data from EXP-6 and EXP-5 are deemed potentially adequate to either support a broader indication or an indication in patients who have received a prior TKI across a wide range of tumor types will be determined at the time of the submission of the pre-NDA meeting package, and ultimately during the review of the NDA submission.

The company plans to provide guidance on the timing of the pre-NDA meeting for repotrectinib in patients with NTRK-positive advanced solid tumors after completion of enrollment of the targeted 40 EXP-6 patients is achieved.

ELZOVANTINIB (TPX-0022), MET/CSF1R/SRC INHIBITOR

The company participated in a Type B meeting with the FDA Division of Oncology 3 (DO3, the division responsible for oversight of gastric cancer therapeutic area). The purpose of the meeting was to discuss the proposed approach to identifying the recommended phase 2 dose (RP2D) and the planned Phase 2 portion of the SHIELD-1 study focused on the potential next steps for elzovantinib in patients with MET amplified gastric/GEJ cancer.

The FDA DO3 agreed with the approach for RP2D identification previously discussed with FDA Division of Oncology 2 (DO2, the division responsible for oversight of lung cancer therapeutic area).

The FDA also agreed with the company’s plan to proceed to the potentially registrational Phase 2 MET amplified gastric/GEJ cancer expansion cohorts of SHIELD-1 after RP2D determination. Based on guidance from the FDA, the company plans to submit data to the FDA from the Phase 2 to discuss the potential registrational aspect of the study. Currently, the company continues to enroll patients within Phase 1 dose expansion using 40 mg QD to 40 mg BID dosing and in Phase 1 dose escalation at the last anticipated dose level of 60 mg QD to 60 mg BID.

The company anticipates initiating the planned Phase 2 portion of SHIELD-1 in 2022.

"We are pleased with the feedback received from the FDA at our recent Type B meetings for repotrectinib and elzovantinib, and look forward to further advancing these important programs," said Mohammad Hirmand, M.D., Chief Medical Officer.