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Italiano Antoine: Phase II Trial in Sarcoma Immunotherapy: Can We Make “Cold” Sarcomas Hot?
Jul 3, 2025, 04:22

Italiano Antoine: Phase II Trial in Sarcoma Immunotherapy: Can We Make “Cold” Sarcomas Hot?

Italiano Antoine, Professor of Medicine Head of Early Phase Trials Unit at the Institut Bergonié, shared a post on LinkedIn:

“New Publication Alert

I’m pleased to share our latest work, just published in Signal Transduction and Targeted Therapy:

‘Reshaping the tumor microenvironment of cold soft-tissue sarcomas with anti-angiogenics: a phase 2 trial of regorafenib combined with avelumab’

In this phase II trial, we explored a challenging but critical question in sarcoma immunotherapy: Can we make “cold” sarcomas hot?

We enrolled patients with TLS-negative soft-tissue sarcomas (STS) – tumors typically unresponsive to immune checkpoint inhibitors. By combining the anti-angiogenic agent regorafenib with the PD-L1 blocker avelumab, we observed:

  • Modulation of the tumor microenvironment
  • Increased infiltration of CD8+ T cells and B cells
  • Elevated PD-1 expression and dynamic immune remodeling
  • But limited clinical responses, highlighting the complexity of immune escape mechanisms in these tumors.

This study confirms that while vascular normalization and immune cell recruitment can be induced pharmacologically, effective immunotherapy will require additional strategies to overcome functional immune suppression.

A big thank you to my colleagues and co-authors, and to all the patients and teams involved in this important step forward for sarcoma research.”

Title: Reshaping the tumor microenvironment of cold soft-tissue sarcomas with anti-angiogenics: a phase 2 trial of regorafenib combined with avelumab

Journal: Signal Transduction and Targeted Therapy

Authors: Maud Toulmonde, Jean-Philippe Guégan, Mariella Spalato-Ceruso, Thibaud Valentin, Rastilav Bahleda, Florent Peyraud, Christophe Rey, Michèle Kind, Coralie Cantarel, Carine Bellera, Lucile Vanhersecke, Alban Bessede, Antoine Italiano

Read the full text.

Sarcoma Immunotherapy

Read more about Sarcoma Immunotherapy on OncoDaily.