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Toll-Like Receptor 4 Agonist Injection With Concurrent Radiotherapy in Patients With Metastatic Soft Tissue Sarcoma:

Yongwoo David Seo1,2, Hailing Lu3, Graeme Black4

  • 1Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston.

JAMA Oncology
|October 12, 2023
PubMed
Summary
This summary is machine-generated.

Intratumoral glycopyranosyl lipid A in stable-emulsion formulation (GLA-SE) combined with radiotherapy is safe for metastatic soft tissue sarcomas. This immunotherapy approach demonstrated durable local control and enhanced antitumor immunity.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Radiotherapy

Background:

  • Metastatic soft tissue sarcomas (STSs) have limited treatment options.
  • Immunotherapy has not significantly improved outcomes for STSs.

Purpose of the Study:

  • To assess the safety, efficacy, and immunomodulatory effects of intratumoral (IT) GLA-SE with concurrent radiotherapy in metastatic STS patients.
  • To evaluate IT GLA-SE in patients with injectable lesions.

Main Methods:

  • Phase 1 nonrandomized controlled trial involving 12 STS patients.
  • Two doses of IT GLA-SE (5 μg and 10 μg) administered weekly for 8 weeks concurrently with radiotherapy.
  • Safety, local response rates, and antitumor immunity (immunohistochemistry, TCR sequencing) were assessed.

Main Results:

  • IT GLA-SE was well tolerated, with only one grade 2 adverse event.
  • All patients achieved local control of the injected lesion; one patient experienced complete regression.
  • Durable local response correlated with increased tumor-infiltrating lymphocytes and expansion of T-cell receptor (TCR) clones in both tumor and circulation.

Conclusions:

  • IT GLA-SE combined with radiotherapy is safe and offers more durable local control than radiotherapy alone for metastatic STS.
  • Enhanced intratumoral T-cell clonal expansion was observed in patients with durable local responses.
  • Further research into combining IT GLA-SE and radiotherapy with systemic immune modulation is warranted.