Turning Point Therapeutics Reports Updated Interim Data From Registrational Phase 2 Trident-1 Study of Repotrectinib in Patients With ROS1-Positive TKI-Naïve Non-Small Cell Lung Cancer
- Phase 2 Confirmed Objective Response Rate is 93% (95% CI: 68-100); Pooled Phase 1/2 Confirmed Objective Response Rate is 91% (95% CI: 71-99)
- Approximately 40 Patients with ROS1-Positive TKI-Naive Non-Small Lung Cancer Now Enrolled in Phase 1/2 TRIDENT-1 Study
- Company Plans to Conduct Type B Meeting with
Food and Drug Administrationin 1H 2021 to Discuss Regulatory Path
In a total of 15 patients enrolled in the Phase 2 portion of the TRIDENT-1 study, the preliminary efficacy analysis showed the confirmed objective response rate (ORR) by physician assessment was 93% (95% CI: 68-100) and in 22 patients pooled from the Phase 1 (dosed at or above the Phase 2 dose) and Phase 2 portions, the confirmed ORR was 91% (95% CI: 71-99).
The findings will be presented in a mini-oral presentation by Dr.
“These interim data confirm our belief that repotrectinib has the potential to be the best-in-class treatment for patients with ROS1-positive TKI-naïve advanced non-small cell lung cancer,” said
- 14 of 15 patients treated in the Phase 2 portion achieved a confirmed ORR of 93% (95% CI: 68-100). At the time of the data cut-off, the one non-responder remained on treatment and in stable disease with a 13% tumor reduction. In addition, one of the 14 patients in a partial response at the time of the data cutoff date has since achieved a confirmed complete response.
- Duration of response ranged from 1.3+ to 7.4+ months, and the duration of treatment ranged from 3.7+ to 10.9+ months with 14 of the 15 patients remaining on treatment. As of the cutoff date, one additional patient (not included in the confirmed ORR calculation) had an unconfirmed partial response and was on treatment awaiting a confirmatory scan. The company’s prior Phase 2 update with the data cutoff date of
July 10, 2020in 7 total patients, showed a confirmed ORR of 86% and a wider 95% confidence interval of 42 to 100.
- 20 of 22 patients pooled from Phase 1 and Phase 2 achieved a confirmed ORR of 91% (95% CI: 71-99). In the 7 patients from the Phase 1 portion dosed at or above the Phase 2 dose, duration of treatment ranged from 10.9 to 37.3 months with a median of 30.9 months, with four patients receiving treatment for longer than 30 months.
- Repotrectinib was generally well tolerated in 185 patients treated in the Phase 1 and Phase 2 portions of the study.
- Treatment-emergent adverse events (TEAE) found in greater than 15 percent of patients were dizziness (58%), dysgeusia (43%), constipation (32%), dyspnea (31%), fatigue (27%), paresthesia (25%), anemia (22%), nausea (20%), and muscular weakness (16%).
- There were four cases of Grade 3 dizziness (2%) and no cases of dizziness have led to treatment discontinuation. Dose modifications due to TEAEs were infrequent, including 18% that led to dose reduction and 9% that led to drug discontinuation.
- The majority of treatment related AEs (TRAEs) were Grade 1 or 2 and there were no Grade 4 or Grade 5 TRAEs.
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 TPX-0022, 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 currently pending IND submission. Turning Point’s next-generation 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, progress and timing of the TRIDENT-1 clinical study, plans regarding future regulatory submissions, 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, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point’s business and the other risks described in Turning Point Therapeutics’ filings with the
Source: Turning Point Therapeutics, Inc.