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Turning Point Therapeutics Initiates Phase 2 Registrational Portion of TRIDENT-1 Clinical Study

1073 Days ago

SAN DIEGO, June 20, 2019 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing novel drugs to address treatment resistance, today announced initiation of the registrational Phase 2 portion of its TRIDENT-1 clinical study of patients with ROS1+ advanced non-small cell lung cancer and TRK+ advanced solid tumors.

Patients will be treated with Turning Point’s lead investigational kinase inhibitor, repotrectinib, which has been studied in more than 80 patients in the ongoing Phase 1 portion of the study.

“Following the Phase 1 results presented last month at the American Society of Clinical Oncology annual meeting, we look forward to launching the broader study of repotrectinib as a precision therapy for patients in the Phase 2 portion of TRIDENT-1,” said Alice T. Shaw, M.D., Ph.D., Professor of Medicine, Harvard Medical School; Director of Thoracic Oncology, Massachusetts General Hospital; and Global Principal Investigator for the study. “The preliminary efficacy and safety data for repotrectinib are promising in both TKI-naïve and pretreated patients, including those with intracranial disease and difficult-to-treat solvent front mutations.”

The study is planned for global site expansion during 2019 and into 2020 at approximately 100 sites. Turning Point Therapeutics expects to enroll approximately 310 patients across five registrational cohorts and anticipates reporting early interim results from initial patients during the second half of 2020.

Screening for the study will involve genetic testing of a sample of the patient’s tumor to identify the presence of genetic alterations, such as ROS1 or NTRK, to determine eligibility for the trial. Repotrectinib is being developed as a precision therapy targeting ROS1 and NTRK-driven cancers.

“Initiation of the Phase 2 registrational portion of TRIDENT-1 is a big step toward getting repotrectinib to many more patients globally who currently have limited treatment options,” said Athena Countouriotis, M.D, chief executive officer of Turning Point Therapeutics. “I am very proud of our team for the timely initiation of the study and look forward to our upcoming discussion with the FDA regarding our recommended Phase 2 dose, and patient dosing in the study.”

Patients eligible for the study will receive the likely recommended Phase 2 dose of 160 mg of repotrectinib once or twice daily, pending upcoming feedback from the FDA.

More information about the TRIDENT-1 study is available at https://www.clinicaltrials.gov/ct2/show/NCT03093116?term=tpx-0005&rank=1.

Repotrectinib is an investigational next-generation TKI designed to target ROS1 and TRK A/B/C and systemically overcome resistant mutations that invariably result following treatment with other TKIs. In the U.S. and Europe (EU5), ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 percent of patients with advanced NSCLC, and NTRK is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors.

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 program, repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is currently being studied in a registrational Phase 2 study, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. Turning Point’s kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.

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. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of repotrectinib, the results, conduct and timing of Turning Point Therapeutics’ Phase 1/2 TRIDENT-1 clinical study, plans regarding future clinical trials and the regulatory approval path for repotrectinib. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify 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, and the other risks described in Turning Point Therapeutics’ filings with the SEC. 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.

Jim Mazzola

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