Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study

Subbiah, V; Hu, MI; Mansfield, AS; Taylor, MH; Schuler, M; Zhu, VW; Hadoux, J; Curigliano, G; Wirth, L; Gainor, JF; Alonso, G; Adkins, D; Godbert, Y; Ahn, MJ; Cassier, PA; Cho, BC; Lin, CC; Zalutskaya, A; Barata, T; Trask, P; Scalori, A; Bordogna, W; Heinzmann, S; Brose, MS

doi:10.1089/thy.2023.0363

Endocrine oncology

Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study

ThyroidPublished 16 Jan 2024Updated analysis of the ARROW phase 1/2 study

An erratum to this article was published (Thyroid, Jul 2025 ↗)

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Authors' conclusion

In this updated analysis of the ARROW study, pralsetinib continued to show deep and durable clinical activity and a manageable safety profile in patients with advanced/metastatic RET-altered thyroid cancer.

Study context

Population: Adults with advanced/metastatic RET-mutant medullary thyroid cancer (MTC) or RET fusion-positive thyroid cancer starting oral pralsetinib 400 mg once dailysafety population
Participants: 175 adults

Comparison: RET-mutant MTC, prior C/V vs Treatment-naïve RET-mutant MTC vs Previously treated RET fusion-positive
RET-mutant MTC, prior C/Vn = 61
Treatment-naïve RET-mutant MTCn = 62
Previously treated RET fusion-positiven = 22
Outcome: Overall response rate (ORR) by blinded independent central review (RECIST v1.1) and safety

Methodological detailsopen-label, Data cut-off October 18, 2021

Open-label
Data cut-off October 18, 2021

Main finding

As reported in the abstract

ORR

RET-mutant MTC, prior C/V55.7%

Treatment-naïve RET-mutant MTC77.4%

Previously treated RET fusion-positive90.9%

Secondary outcomes

Outcome	RET-mutant MTC, prior C/VMedian, months	Treatment-naïve RET-mutant MTC	Previously treated RET fusion-positiveMedian, months
Median DoR	25.8	median not reached	23.6
Median PFS	25.8	median not reached	25.4

Patient-reported outcomes (exploratory)

Patient-reported outcomes (PROs) improved or remained stable after pralsetinib

Safety

Treatment-related adverse events (safety population, N = 175)

Any treatment-related adverse event (TRAE): 97.1%
TRAE leading to discontinuation: 5.7%
TRAE leading to dose reduction: 52.6%
Death due to a TRAE: 1 (0.6%)

Original publication

Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study. Thyroid. Published 16 January 2024. doi:10.1089/thy.2023.0363

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