ROS1+ TKI-Naïve Non-Small Cell Lung Cancer Confirmed Objective Response Rate is 86 Percent
ROS1+ TKI-Pretreated Non-Small Cell Lung Cancer with One Prior TKI and Prior Chemotherapy, Confirmed Objective Response Rate is 40 Percent
ROS1+ TKI-Pretreated Non-Small Cell Lung Cancer with One Prior TKI without Prior Chemotherapy, Confirmed Objective Response Rate is 67 Percent
NTRK+ TKI-Pretreated Advanced Solid Tumors Confirmed Objective Response Rate is 50 Percent
Recent FDA Feedback on TRIDENT-1 Study May Provide Faster Path to Potential Approval
Conference Call Scheduled for 8:00 a.m. EDTSAN DIEGO, Aug. 19, 2020 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today reported early interim data from the registrational Phase 2 TRIDENT-1 study of lead drug candidate, repotrectinib, and announced recent regulatory feedback from the Food and Drug Administration (FDA) on the TRIDENT-1 trial design.“We are very encouraged by the early interim data from the Phase 2 TRIDENT-1 study as they reaffirm our belief that repotrectinib has the potential to be the best-in-class treatment for patients with ROS1- or NTRK-driven tumors, including patients who are TKI-naïve and TKI-pretreated,” said Athena Countouriotis, M.D., president and chief executive officer. “Additionally, we recently received FDA feedback that may provide a faster path to potential approval, including pooling of patients from the Phase 1 portion of the study treated at the recommended dose of repotrectinib with patients treated in the Phase 2 portion, and cohort sample size modifications. Hence, we are modifying the TRIDENT-1 study sample sizes and adding new interim analyses that may support approval into two of our ROS1-positive TKI-pretreated patient cohorts. We now anticipate providing an update in early 2021 on the overall study timelines.”Early Interim Phase 2 Data from TRIDENT-1 Study
The early Phase 2 TRIDENT-1 dataset utilizing a July 10, 2020 data cutoff includes the first 39 treated patients who have had at least one post-baseline scan. Responses were confirmed with a subsequent scan at least 28 days later per RECIST 1.1 and were determined by physician assessment. Patients were enrolled across six countries.Phase 2 Preliminary Efficacy Analysis (n=39)Across all cohorts reported, median follow-up was 3.6 months (range: 0.4 – 7.4+), and median duration of treatment was 3.7 months (range: 0.7-8.2+)
In the ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC) population (EXP-1: n=7):
Six patients achieved a confirmed response for an Objective Response Rate (ORR) of 86 percent. The duration of response ranged from 0.9+ to 2.0+ months and all patients who achieved a response remained in a response at the time of the data cutoff.
Since the July 10 data cutoff, the seventh patient in this cohort has achieved an unconfirmed partial response and remains on treatment awaiting a confirmatory scan.
In the ROS1-positive NSCLC population pretreated with one prior TKI with prior chemotherapy (EXP-2: n=5):
Two patients achieved a confirmed response for an ORR of 40 percent. The durations of response were 4.5 and 5.6+ months at the time of the data cutoff.
In the ROS1-positive NSCLC population pretreated with one prior TKI without prior chemotherapy (EXP-4: n=6):
Four patients achieved a confirmed response for an ORR of 67 percent. The duration of response ranged from 1.0+ to 5.7+ months with all four patients remaining in a response at the time of the data cutoff.
In the ROS1-positive NSCLC population pretreated with two prior TKIs with prior chemotherapy (EXP-3: n=10):
No objective responses were observed within this heavily pretreated fourth-line patient population, yet five patients achieved stable disease.
The company recently recommended to the study’s data monitoring committee (DMC) that expansion cohort three (EXP-3) be modified to remove the requirement for prior chemotherapy based on limited activity to date in this fourth-line patient cohort. The company’s intent is to only support third-line patients in this cohort going forward and to preserve the opportunity to evaluate these patients as the treatment landscape changes with less chemotherapy use. The DMC recommended the study proceed and agreed with the recommended change to cohort three.
In the ROS1-positive NSCLC population pretreated with two prior TKIs without prior chemotherapy (patients enrolled under the initial protocol and analyzed for efficacy in a separate cohort, EXP-Other: n=5):
Two patients achieved a confirmed response for an ORR of 40 percent. Both patients remained in a response with a duration of 1.9+ months at the time of the data cutoff.
In the NTRK-positive TKI-pretreated solid tumor population (EXP-6: n=6):Three patients achieved a confirmed response for an ORR of 50 percent. The duration of response ranged from 1.7+ to 3.6+ months with all three patients remaining in a response at the time of the data cutoff.Data from the Phase 1 (at all doses studied) and Phase 2 of the TRIDENT-1 study are summarized in the table below.
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