Turning Point Therapeutics Announces Initial Clinical Data From Phase 1/2 SWORD-1 Study of RET Inhibitor TPX-0046
SAN DIEGO, April 05, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today reported initial clinical data from the ongoing Phase 1/2 SWORD-1 study of its RET inhibitor drug candidate, TPX-0046.
The initial data from the Phase 1 dose finding portion of the study showed preliminary clinical activity, including objective responses and a generally well-tolerated safety profile. Turning Point continues to evaluate doses and schedules to determine a recommended Phase 2 dose, and plans to revise the study protocol to include Phase 1 expansion cohorts at the recommended Phase 2 dose.
TPX-0046 Initial Clinical Data
All 16 TKI-pretreated patients were previously treated with a selective RET TKI and 9 patients (56%) were treated with more than 1 prior TKI. Ninety-one percent of patients (19/21) had a baseline ECOG performance score of 1, and nearly half (10/21) received 3 or more prior therapies.
Preliminary efficacy data by investigator assessment was available for 14 evaluable patients with baseline measurable disease and at least one post-baseline assessment per RECIST v1.1, including TKI-naïve NSCLC (n=3) and MTC (n=2), and TKI-pretreated NSCLC (n=4) and MTC (n=5).
As of the March 10, 2021 data cut-off date:
Preliminary Safety and Pharmacokinetic Results
“Given the encouraging data we have seen, we plan to modify the SWORD-1 study to include a dose expansion portion utilizing additional clinical sites,” said Mohammad Hirmand, M.D., executive vice president and chief medical officer of Turning Point Therapeutics. “We look forward to advancing our development of TPX-0046 in both the RET-positive TKI-naïve and less heavily pretreated TKI-pretreated settings.”
After determination of the recommended Phase 2 dose, Turning Point plans to study TPX-0046 in multiple Phase 1 dose expansion cohorts in up to 75 patients with RET-altered malignancies prior to an end of Phase 1 meeting with the Food and Drug Administration.
Webcast and Conference Call
The discussion will be accessible through the "Investors" section of tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 9939858. A replay will be available through the "Investors" section of www.tptherapeutics.com.
About Turning Point Therapeutics Inc.
Forward Looking Statements