Turning Point/Redding repotrectinib Total remission rate of lung cancer treatment is 93%

The updated interim results of the Phase 2 Trident-1 study targeting the anti-cancer drug repotrectinib for the treatment of lung cancer were presented at the 21st World Lung Cancer Congress (WCLC) online conference hosted by the International Lung Cancer Research Association.
the study was conducted in ros1-positive non-small cell lung cancer (NSCLC) patients who had not previously received tyrosine kinase inhibitors (TKI primary treatment) and is evaluating the efficacy and safety of repotrectinib.
A total of 15 patients were included in phase 2 of the study, and preliminary efficacy analysis showed that the objective remission rate (ORR) confirmed by the doctor's assessment was 93% (95% CI:68-100);
The updated data confirm our belief that repotrectinib has the potential to be the best treatment for patients with ros1-positive TKI advanced non-small cell lung cancer," said Dr. Mohammad Hirmand, Chief Medical Officer, Turing Point Therapeutics.
so far, we have included approximately 40 patients with ROS1-positive TKI initial treatment with doses equal to or higher than phase 2 doses in phases 1 and 2 of the TRIDENT-1 study.
the number of participants has increased encouragingly since our data update last August.
look forward to holding a Type B meeting with the FDA in the first half of this year to discuss the next steps in repotrectinib's registration with this group.
" using December 31, 2020 as the deadline, the initial midterm efficacy update of the TRIDENT-1 study included 22 ROS1-positive, TKI primary NSCLC patients from phase 1 of the study (dose equal to or above phase 2 dose) and phase 2 patients who underlyed at least 2 post-baseline scans.
patient remission in phase 2 of the study was determined by a doctor's assessment.
mid-term safety update includes a total of 185 patients from the Phase 1 and Phase 2 parts of the study, with a deadline of 30 October 2020.
of the 15 patients treated in phase 2, 14 had a confirmed ORR of 93% (95% CI: 68-100).
at the data cut-off, one non-responder was still being treated, stable and the tumor was 13 percent smaller.
addition, 1 in 14 patients who achieved partial remission (PR) at the data due date had a confirmed complete remission (CR).
duration was 1.3 to 7.4 plus months, treatment duration was 3.7 to 10.9 plus months, and 14 out of 15 patients were still receiving treatment.
the deadline, another patient (not included in the confirmed ORR calculation) had an unrefirmed partial reaction and was being treated pending a confirmation scan.
the company's previous deadline of July 10, 2020 for two updates was July 10, 2020, with an ORR of 86% (95% CI:42-100) confirmed in seven patients.
20 of the 22 patients identified from Phase 1 and Phase 2 were in remission, with a confirmed ORR of 91% (95% CI:71-99).
in 7 patients who were given phase 1 partial dose equal to or higher than phase 2 partial dose, the duration of treatment was 10.9 to 37.3 months, with a median of 30.9 months, of which 4 patients had a duration of more than 30 months.
in 185 patients who were treated with Phase 1 and Phase 2 of the study, the tolerance of repotrectinib was generally good.
Adverse events (TEAE) during treatment in more than 15% of patients were dizziness (58%), stuttering difficulties (43%), constipation (32%), breathing difficulties (31%), fatigue (27%), sensory abnormalities (25%), anemia (22%), nausea (20%) and muscle weakness (16%).
4 cases (2%) of stage 3 vertigo, none of which resulted in suspension of medication.
dose changes caused by TAAE are rare, including 18% resulting in dose reduction and 9% stoppage.
treatment-related adverse events (TRAEs) are mostly level 1 or 2, with no level 4 or 5.
repotrectinib Chemical Structure (Photo: selleckchem.com) repotrectinib is a new generation tyrosine kinase inhibitor (TKI) in the study that is effective for ROS1 and TRKA/B/C (encoded by the NTRK1/2/3 gene) and has therapeutic potential for patients who have not been treated with TKI or have already used TKI.
in Greater China, more than 700,000 new lung cancer patients are diagnosed each year.
as a cancer-causing gene change, ROS1 rearms account for about 2% to 3% of patients with advanced NSCLC, and NTRK gene fusion accounts for about 0.5% of patients with other advanced solid tumors.
July 2020, Redding Pharmaceuticals signed an exclusive licensing agreement with Turing Point Therapeutics to promote the development and commercialization of repotrectinib in Greater China (Chinese mainland, Hong Kong, Macau and Taiwan).
Under the terms of the agreement, Repotrectinib will receive exclusive development and commercial rights in Greater China, and TurningPoint Therapeutics will receive a cash advance of $25 million and be eligible for potential development, registration and sales-based milestone payments of up to $151 million.
addition, Redding Pharmaceuticals will pay royalties to TuringPoint based on the annual net sales of repotrectinib in Greater China.
the announcement at the time, Redding Pharmaceuticals will launch more research centers for the TRIPENT-1 Clinical Phase 2 registered study of repotrectinib.
the study is currently recruiting PATIENTs with ROS1-positive advanced non-small cell lung cancer (NSCLC) and NTRK gene fusion-positive solid tumors in 11 countries and territories.
data from Phase I of the Trident-1 Study as of 22 July 2019 show that the efficacy of repotrectinib in patients with ROS1-positive advanced NSCLC who have not previously been treated with TKI will give them the potential to become Best-in-class products: Total mitigation rate (ORR) of 91%, medium mitigation duration (DOR) of 23.1 months, medium progression-free lifetime (PFS) of 24.6 months, and good overall tolerance.
in China, there is currently only one approved targeted therapy for patients with advanced ROS1-positive lung cancer, Xalkori, Pfizer products.
although the efficacy of the drug is accurate, patients inevitably develop drug resistance, ROS1-positive lung cancer patients treatment is still large unsatisfying demand.
preliminary data show good efficacy and safety, and if approved, repotrectinib could become one of the standard treatments for patients with ros1-positive late NSCLC in China.
original source: TurningPoint Therapeutics Reports Updated Interim Data From Registration Alpha 2 Trident-1 Study of Repotrectinib in Patients With ROS1-PositiveTKI-Naïve Non-Small Cell Cancer Cancer Source: Supplied