FP14.05 LIBRETTO-431: Selpercatinib in Treatment-Naïve Patients with RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC).

Goto, Kōichi; Wolf, J.; Elamin, Yasir Y.; Santini, Fernando C.; Soldatenkova, Victoria; Sashegyi, Andreas; Lin, Aimee Bence; Lin, Benyao; Novello, Silvia; Aperribay, E. Arriola; Pérol, Maurice; Loong, Herbert H.; Drilon, Alexander; Park, K.; Solomon, B.; Zhou, Caicun

doi:10.1016/j.jtho.2021.01.148

Cited by 5 publications

(5 citation statements)

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“…In addition, our study also reported a longer median time to worsening of physical function (19.2 months) from another PRO study in Asian patients with NSCLC, where the median time to deterioration of physical function was 14 months. 30 In another paper that assessed PRO data from LIBRETTO-001, a lower proportion of selpercatinib-treated patients reported worsening symptoms versus the control group (23% versus 43%). 31 Findings associated with other symptoms such as pain, fatigue, and insomnia were similar to results reported in prior research 17 ; in our study, >80% of patients with NSCLC reported improved or stable scores for these symptoms at each postbaseline assessment cycle.…”

Section: Discussionmentioning

confidence: 99%

Patient-reported outcomes with selpercatinib treatment in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial

Raez,

Kang,

Ohe

et al. 2024

ESMO Open

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Section: Discussionmentioning

confidence: 99%

Patient-reported outcomes with selpercatinib treatment in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial

Raez,

Kang,

Ohe

et al. 2024

ESMO Open

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“…93 An ongoing phase III study (LIBRETTO-431 trial, ClinicalTrials.gov identifier: NCT04194944) on selpercatinib versus chemotherapy in treatment-na ïve locally advanced or metastatic RET1 NSCLC is awaiting results. 94 In the phase I/II ARROW study, pralsetinib, a highly selective TKI targeting RET fusions and mutations, was evaluated in 223 patients with RET fusion-positive NSCLC. 19 RET alterations were detected with FISH of tumor or NGS with tumor or ctDNA.…”

Section: Detection Methodsmentioning

confidence: 99%

Section: Ret Fusionmentioning

confidence: 99%

Path Less Traveled: Targeting Rare Driver Oncogenes in Non–Small-Cell Lung Cancer

Lim,

Lee,

Oya

et al. 2024

JCO Oncol Pract

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Over the past decade, tremendous efforts have been made in the development of targeted agents in non–small-cell lung cancer (NSCLC) with nonsquamous histology. Pivotal studies have used next-generation sequencing to select the patient population harboring oncogenic driver alterations that are targetable with targeted therapies. As treatment paradigm rapidly evolves for patients with rare oncogene-driven NSCLC, updated comprehensive overview of diagnostic approach and treatment options is paramount in clinical settings. In this review article, we discuss the epidemiology, molecular testing, and landmark clinical trials addressing the targeted agents for ROS1 rearrangement, METex14 skipping mutation, EGFR exon 20 insertion, KRAS G12C mutation, HER2 mutation, RET fusion, NTRK fusion, and BRAF mutations.

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“…25 For example, RET inhibitor selpercatinib was evaluated for the treatment of RET-positive aNSCLC in the LIBRETTO-001 SAT (ClinicalTrials.gov identifier: NCT03157128). 112,113 Comparative analysis between the LIBRETTO-001 study and EC demonstrated that the improvement in survival outcomes was similar between an EC with RET-positive aNSCLC and an EC (without RET fusion) with RET adjustment factor applied. 25 This novel technique is considered exploratory but warrants further research.…”

Section: Innovative Clinical Trial Designs Leveraging Ecmentioning

confidence: 98%

Framework for the Use of External Controls to Evaluate Treatment Outcomes in Precision Oncology Trials

Siu,

Lin,

Cho

et al. 2024

JCO Precis Oncol

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Advances in genomics have enabled anticancer therapies to be tailored to target specific genomic alterations. Single-arm trials (SATs), including those incorporated within umbrella, basket, and platform trials, are widely adopted when it is not feasible to conduct randomized controlled trials in rare biomarker-defined subpopulations. External controls (ECs), defined as control arm data derived outside the clinical trial, have gained renewed interest as a strategy to supplement evidence generated from SATs to allow comparative analysis. There are increasing examples demonstrating the application of EC in precision oncology trials. The prospective application of EC in conducting comparative studies is associated with distinct methodological challenges, the specific considerations for EC use in biomarker-defined subpopulations have not been adequately discussed, and a formal framework is yet to be established. In this review, we present a framework for conducting a prospective comparative analysis using EC. Key steps are (1) defining the purpose of using EC to address the study question, (2) determining if the external data are fit for purpose, (3) developing a transparent study protocol and a statistical analysis plan, and (iv) interpreting results and drawing conclusions on the basis of a prespecified hypothesis. We specify the considerations required for the biomarker-defined subpopulations, which include (1) specifying the comparator and biomarker status of the comparator group, (2) defining lines of treatment, (3) assessment of the biomarker testing panels used, and (4) assessment of cohort stratification in tumor-agnostic studies. We further discuss novel clinical trial designs and statistical techniques leveraging EC to propose future directions to advance evidence generation and facilitate drug development in precision oncology.

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FP14.05 LIBRETTO-431: Selpercatinib in Treatment-Naïve Patients with RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC).

Cited by 5 publications

References 0 publications

Patient-reported outcomes with selpercatinib treatment in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial

Patient-reported outcomes with selpercatinib treatment in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial

Path Less Traveled: Targeting Rare Driver Oncogenes in Non–Small-Cell Lung Cancer

Framework for the Use of External Controls to Evaluate Treatment Outcomes in Precision Oncology Trials

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