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Results from Phase I Extension Study Assessing Pexidartinib Treatment in Six Cohorts with Solid Tumors including TGCT, and Abnormal CSF1 Transcripts in TGCT. | LitMetric

AI Article Synopsis

  • The study aimed to evaluate the effects of pexidartinib, a tyrosine kinase inhibitor targeting CSF1R and KIT, in adult patients with advanced solid tumors, particularly focusing on those with tenosynovial giant cell tumors (TGCT).
  • A total of 91 patients participated, with TGCT patients experiencing a longer median treatment duration and notable response rates, while evidence of CSF1 transcript abnormalities was found in a majority of TGCT tissue biopsies.
  • The findings suggest that pexidartinib can lead to tumor regression and symptom relief in TGCT patients, demonstrating a favorable safety profile throughout the study.

Article Abstract

Purpose: To assess the response to pexidartinib treatment in six cohorts of adult patients with advanced, incurable solid tumors associated with colony-stimulating factor 1 receptor (CSF1R) and/or KIT proto-oncogene receptor tyrosine kinase activity.

Patients And Methods: From this two-part phase I, multicenter study, pexidartinib, a small-molecule tyrosine kinase inhibitor that targets CSF1R, KIT, and FMS-like tyrosine kinase 3 (FLT3), was evaluated in six adult patient cohorts (part 2, extension) with advanced solid tumors associated with dysregulated CSF1R. Adverse events, pharmacokinetics, and tumor responses were assessed for all patients; patients with tenosynovial giant cell tumor (TGCT) were also evaluated for tumor volume score (TVS) and patient-reported outcomes (PRO). CSF1 transcripts and gene expression were explored in TGCT biopsies.

Results: Ninety-one patients were treated: TGCT patients ( = 39) had a median treatment duration of 511 days, while other solid tumor patients ( = 52) had a median treatment duration of 56 days. TGCT patients had response rates of 62% (RECIST 1.1) and 56% (TVS) for the full analysis set. PRO assessments for pain showed improvement in patient symptoms, and 76% (19/25) of TGCT tissue biopsy specimens showed evidence of abnormal CSF1 transcripts. Pexidartinib treatment of TGCT resulted in tumor regression and symptomatic benefit in most patients. Pexidartinib toxicity was manageable over the entire study.

Conclusions: These results offer insight into outcome patterns in cancers whose biology suggests use of a CSF1R inhibitor. Pexidartinib results in tumor regression in TGCT patients, providing prolonged control with an acceptable safety profile.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9401544PMC
http://dx.doi.org/10.1158/1078-0432.CCR-21-2007DOI Listing

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