ESMO 2025 | CONgRAtS: TLS-guided immunotherapy in soft-tissue sarcomas
Florent Peyraud, MD, PhD, Institut Bergonié, Bordeaux, France, discusses the Phase II CONgRAtS trial (EudraCT 2019-002332-81), the first study to validate tertiary lymphoid structures (TLS) as a predictive biomarker in soft-tissue sarcomas (STS). Patients with TLS-positive STS were randomized to nivolumab with or without relatlimab. Both treatment arms exceeded historical benchmarks for progression-free rate, though adding relatlimab did not enhance efficacy over PD-1 monotherapy. The study supports TLS-guided patient selection for immunotherapy and provides insights into immune architecture and response mechanisms in sarcoma. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
Up to 40% of sarcoma patients will develop metastatic disease, so the characteristics of this disease are really dismal and palliative chemotherapy remains the standard of care for this patient. Historically, anti-PD-1 or PD-L1 inhibitions with antibodies have shown only poor response with only 2.3% of response rates in the PEMBROSARC trial in unselected sarcomas. So with the identification of TLS as a predictive biomarker of response to immunotherapy, we decided to develop these studies...
Up to 40% of sarcoma patients will develop metastatic disease, so the characteristics of this disease are really dismal and palliative chemotherapy remains the standard of care for this patient. Historically, anti-PD-1 or PD-L1 inhibitions with antibodies have shown only poor response with only 2.3% of response rates in the PEMBROSARC trial in unselected sarcomas. So with the identification of TLS as a predictive biomarker of response to immunotherapy, we decided to develop these studies. In addition, LAG3 is another immune checkpoint expressed especially in TLS-positive sarcomas, and these patients have a dismal prognosis. So this provided the rationale to combine the anti-PD-1 nivolumab with anti-LAG3 relatlimab in TLS-positive soft tissue sarcomas. CONgRAtS is the first randomized trial that uses a biomarker strategy to select patients for immune checkpoint inhibition. The results are really interesting in this population with a six-month non-progression rate of more than 20% for the combination and almost 40% for the nivolumab monotherapy. So the result significance for us is that nivolumab alone is probably the best strategy for TLS-positive sarcoma with no impact of the addition of relatlimab.
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