Press Release

Turning Point Therapeutics Provides Regulatory Updates

SAN DIEGO, Dec. 20, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced 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. These updates follow FDA meetings held earlier in December.


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.


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.

About Turning Point Therapeutics Inc.
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes elzovantinib, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit

Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics’ drug candidates, repotrectinib and elzovantinib, plans regarding clinical trials, regulatory meetings and regulatory submissions, and the regulatory approval paths for repotrectinib and elzovantinib. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point Therapeutics’ business and the other risks described in Turning Point Therapeutics’ filings with the SEC, including its quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 9, 2021. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Adam D. Levy, PhD, MBA


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Source: Turning Point Therapeutics, Inc.