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Association details:
| Biomarker: | ROS1 G2032R |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Augtyro (repotrectinib) (ALK inhibitor, Multi-tyrosine kinase inhibitor, ROS1 inhibitor, Trk inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Repotrectinib in Patients with ROS1 Fusion-positive (ROS1+) NSCLC: Update from the Pivotal Phase 1/2 TRIDENT-1 Trial
Published date:
08/08/2023
Excerpt:
Intracranial ORR and additional efficacy are reported below in the Table. In patients with TKI-pretreated ROS1 G2032R NSCLC (n=17), cORR was 59% (33-82)...With 14 months’ minimum follow-up in TRIDENT-1, repotrectinib continued to demonstrate durable efficacy in patients with ROS1+ NSCLC, including intracranial activity, in both TKI-naïve and 1 prior TKI and no chemo cohorts.
Source:
Title:
Pivotal Data Update from the Phase 1/2 TRIDENT-1 Trial of Repotrectinib in Patients with ROS1+ Advanced Non-Small Cell Lung Cancer (NSCLC)
Published date:
01/28/2023
Excerpt:
Patients with ROS1+ NSCLC were assigned to 1 of 4 expansion cohorts….In TKI-naïve patients, cORR (95% CI) was 79% (68, 88); 12-month DOR (95% CI) was 86% (76, 96); 12-month PFS (95% CI) was 80% (70, 90). Additional efficacy data, including outcomes in TKI-pretreated cohorts and cORR by age, are shown in the Table. In TKI-pretreated patients with ROS1 G2032R NSCLC (n = 17), cORR was 59% (6-month DOR [95% CI]: 70% [42, 98])....In both TKI-naïve and TKI-pretreated patients with ROS1+ advanced NSCLC, repotrectinib achieves durable activity, including intracranial responses, and responses in those with ROS1 G2032R.
Trial ID:
Source:
Title:
Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naïve and Solvent-Front-Mutant ROS1-Rearranged Non-Small Cell Lung Cancer
Published date:
04/10/2020
Excerpt:
Notably, repotrectinib showed selective and potent in vitro and in vivo activity against ROS1G2032R....Repotrectinib is a novel next-generation ROS1-TKI with improved potency and selectivity against treatment-naïve and ROS1G2032R with efficient CNS penetration.
DOI:
10.1158/1078-0432.CCR-19-2777
Trial ID:
Source:
Title:
Safety and preliminary clinical activity of repotrectinib in patients with advanced ROS1 fusion-positive non-small cell lung cancer (TRIDENT-1 study).
Excerpt:
Among 10 evaluable TKI-naïve ROS1+ NSCLC pts, confirmed ORR by Blinded Central Review (BCR) was 90% (95% CI 56 - 100) with median duration of response (DOR) not reached ((range 5.5+ – 14.9+ months (mos)). Among 18 TKI-pretreated pts, confirmed ORR by BCR was 28% (95% CI 10 – 54) with DOR of 10.2 mos.
DOI:
10.1200/JCO.2019.37.15_suppl.9011
Trial ID:
Source:
Title:
Repotrectinib (TPX-0005) Is a Next-Generation ROS1/TRK/ALK Inhibitor That Potently Inhibits ROS1/TRK/ALK Solvent- Front Mutations
Excerpt:
A 41-year-old Asian female never-smoker presented with stage IV NSCLC...A repeat biopsy and comprehensive genomic profiling at Foundation Medicine revealed CD74–ROS1 and a ROS1 G2032R SFM. The patient subsequently enrolled on the phase I repotrectinib trial and received repotrectinib at 160 mg once daily...A confirmed PR (−36.6%) by RECIST v1.1 was achieved with a duration of response of 7.4 months. Of note, this patient also responded to repotrectinib in the CNS for 9 months with subsequent CNS-only progression controlled by whole-brain radiation (WBRT) with continuation of repotrectinib during WBRT without any adverse events.
DOI:
10.1158/2159-8290.CD-18-0484
Trial ID:
Source:
Title:
Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naïve and Solvent-Front–Mutant ROS1-Rearranged Non–Small Cell Lung Cancer
Published date:
04/08/2020
Excerpt:
Notably, repotrectinib showed selective and potent in vitro and in vivo activity against ROS1G2032R.
DOI:
10.1158/1078-0432.CCR-19-2777
