151TiP TANGENT: A phase III, global, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of emactuzumab in patients with tenosynovial giant cell tumor

follow up, n6, 46% experienced rash; n6, 46% diarrhea; n3, 23% required phosphate supplement.Delayed AEs included a case of hidradenitis.Among the 4 female pts, 3 (75%) experienced ovarian toxicity.The 3 pts who underwent dose reductions did so due to rash, diarrhea and fatigue; and diarrhea, respectively.All pts tolerated the reduced dose of 100 mg BID.At the most recent follow-up, 8 pts (62%) had reported improved pain from baseline. 2 out of 5 pts (40%) with intrabdominal tumors had RECIST 1.1 partial response.Conclusions: Nirogacestat was well tolerated, with management of AEs at first month associated with dose interruptions but infrequent dose reductions.Our findings support the recommended starting dose of 150 mg twice daily (BID) in real-world experience.

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Publication Details

Journal
ESMO Open
Published
2025-03-01
DOI
https://doi.org/10.1016/j.esmoop.2025.104464
Citations
1
Primary Topic
Musculoskeletal synovial abnormalities and treatments
Type
article
Field-Weighted Citation Impact
1.67
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article

151TiP TANGENT: A phase III, global, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of emactuzumab in patients with tenosynovial giant cell tumor

Javier Martín‐Broto, Gabriel Tinoco, Matthew Davies, Elyse Seltzer et al.
1 citations
ESMO Open
Musculoskeletal synovial abnormalities and treatments
1.67
article

151TiP TANGENT: A phase III, global, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of emactuzumab in patients with tenosynovial giant cell tumor

Javier Martín‐Broto, Gabriel Tinoco, Matthew Davies, Elyse Seltzer, Jean‐Yves Blay, M. Van de Sande, H. Gelderblom, Emanuela Palmerini, S. Veltkamp, A. Sebio García
article en
1 citations

Abstract

follow up, n6, 46% experienced rash; n6, 46% diarrhea; n3, 23% required phosphate supplement.Delayed AEs included a case of hidradenitis.Among the 4 female pts, 3 (75%) experienced ovarian toxicity.The 3 pts who underwent dose reductions did so due to rash, diarrhea and fatigue; and diarrhea, respectively.All pts tolerated the reduced dose of 100 mg BID.At the most recent follow-up, 8 pts (62%) had reported improved pain from baseline. 2 out of 5 pts (40%) with intrabdominal tumors had RECIST 1.1 partial response.Conclusions: Nirogacestat was well tolerated, with management of AEs at first month associated with dose interruptions but infrequent dose reductions.Our findings support the recommended starting dose of 150 mg twice daily (BID) in real-world experience.

ESMO OpenVol. 10
The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (US), Leiden University Medical Center (NL), Hospital de Sant Pau (ES), PsiOxus Therapeutics (United Kingdom) (GB), Centre Léon Bérard (FR), Istituto Ortopedico Rizzoli (IT), Hospital Universitario Fundación Jiménez Díaz (ES)
Good health and well-being
Openalex Percentile: Top 19%
Musculoskeletal synovial abnormalities and treatments
1.67
DOIOpen Access PDFOpenAlex
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151TiP TANGENT: A phase III, global, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of emactuzumab in patients with tenosynovial giant cell tumor — Javier Martín‐Broto, Gabriel Tinoco, et al. · ESMO Open (2025) | TGRS Research Map | TGRS