Reference Detail

Ref Type

abstract

PMID

Authors

M. Pérol,N. Yang,C-M. Choi,Y. Ohe,S. Sugawara,N. Yanagitani,G. Liu,F.G.M. De Braud,J. Nieva,M. Nagasaka,L. Bazhenova,C. Zhou,E. Felip,X. Zhang,S. Li,N.A. Pennell

Title

1373P Efficacy and safety of taletrectinib in patients (Pts) with ROS1+ non-small cell lung cancer (NSCLC): Interim analysis of global TRUST-II study

Journal	Vol	Issue	Date	Pages	Journal Short Title
Annals of Oncology	34	Suppl_2	2023

URL

https://www.annalsofoncology.org/article/S0923-7534(23)03243-X/fulltext#secsectitle0030

Abstract Text

Background Taletrectinib, a next-generation, CNS-active, ROS1 TKI with selectivity over TRKB, demonstrated high overall and intracranial response rates, prolonged PFS, activity against G2032R, and was well tolerated in TRUST-I (NCT04395677). We report interim results of taletrectinib from the pivotal phase 2 trial, TRUST-II (NCT04919811), in advanced ROS1+ NSCLC pts from North America, Europe, and Asia. Methods TRUST-II, a multicenter, open-label, single-arm study in pts with ROS1+ tumors, has 4 cohorts: 1) NSCLC: ROS1 TKI-naive, ≤1 line of chemotherapy (CT); 2) NSCLC: 1 prior ROS1 TKI, ≤1 line of CT; 3) NSCLC: ≥2 ROS1 TKIs, ≤1 line of CT; and 4) solid tumors including NSCLC if ineligible for cohorts 1-3: ≤3 ROS1 TKIs, ≤2 lines of CT. Eligible pts had ECOG PS 0–1 and could have asymptomatic or treated/controlled CNS involvement. All pts started taletrectinib at 600 mg QD. The primary endpoint is independent review committee (IRC)-assessed confirmed objective response rate (cORRIRC); other key endpoints include investigator-assessed cORR (cORRINV), disease control rate (DCR), time to treatment response (TTR), DoR, PFS, and safety. Results Interim efficacy results are from 18 pts in cohort 1 and 22 pts in cohort 2 with ≥2 disease assessments (39% and 59% of pts had brain metastases, respectively). cORRINV was 94% (17/18; 95% CI: 73, 100) in cohort 1 and 55% (12/22; 95% CI: 32, 76) in cohort 2; DCR was 100% and 91%, respectively. cORRIRC will be presented. In both cohorts, median TTR was 1.4 mo; median DoR was not reached. As of March 31, 2023, 72 pts were included in the safety population that received ≥1 dose of taletrectinib. Median duration of exposure was 3.7 mo. Overall, 90% had a treatment-emergent adverse event (TEAE), mostly grade 1–2. The most common TEAEs were increased ALT (61%) or AST (61%), and nausea (38%). No treatment-related AE (TRAE) led to discontinuation or death; 24% of pts had a TRAE leading to dose reduction. Conclusions In this ongoing global pivotal phase 2 study, taletrectinib demonstrated robust and consistent clinical activity with TRUST-I, including high response rates and a tolerable safety profile in both TKI-naive and TKI-pretreated pts with ROS1+ NSCLC.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
ROS1 fusion	lung non-small cell carcinoma	predicted - sensitive	Taletrectinib	Phase II	Actionable	In a Phase II trial (TRUST-II), Taletrectinib (DS6051b) treatment demonstrated safety in ROS1 fusion-positive non-small cell lung cancer patients and resulted in a confirmed investigator-assessed objective response rate (cORRinv) of 94% (17/18) and a disease control rate (DCR) of 100% in the treatment-naive cohort and a cORRinv of 55% (12/22) and DCR of 91% in the previously treated cohort (Ann Oncol (2023) 34 (suppl_2):S788-S789; NCT04919811).	detail...