New Phase II Randomised Data reveals the Advantages of Immunotherapy for Patients with High-Risk Soft Tissue Sarcoma of the Limb

New Phase II Randomised Data reveals the Advantages of Immunotherapy for Patients with High-Risk Soft Tissue Sarcoma of the Limb

The groundbreaking findings from an international collaborative clinical trial were unveiled today at the prestigious American Society of Clinical Oncology (ASCO) conference in Chicago on the 3rd of June 2024.

The international, multicentre trial is led by the Sarcoma Alliance Research Collaboration (SARC) in the USA and the Australia and New Zealand Sarcoma Association (ANZSA) in Australia - the Randomised Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity (SARC032) - marks a significant advancement in the treatment landscape for patients battling high-risk, localised soft tissue sarcoma of the limb.


SARC032 is the first completed randomised clinical trial of its kind.  It demonstrated compelling evidence to integrate immunotherapy, specifically pembrolizumab, with the standard treatment regimen of radiotherapy and surgery for patients with grade 2 or 3, stage III soft tissue sarcoma of the limb.

  • Significant Improvement in Disease-Free Survival: The addition of pembrolizumab demonstrated a remarkable reduction in recurrence of the sarcoma.  
  • Risk Reduction: Pembrolizumab significantly reduced the risk of sarcoma recurrence or death by an impressive 18%, underscoring its potential as a vital therapeutic option in high-risk sarcoma.
  • Acceptable Safety Profile: Alongside its efficacy, pembrolizumab exhibited an acceptable safety profile.


With these compelling results, pembrolizumab emerges as a new potential option for patients grappling with high-risk sarcoma of the limb. Prof. Angela Hong, Australia’s Principal Investigator for the trial, believes these results will be beneficial for patients for this specific stage of sarcoma.

 “This is a significant milestone. The integration of immunotherapy into standard treatment protocols heralds a new era in sarcoma management, offering patients and clinicians a potent tool in the battle against this formidable disease.”


Soft tissue sarcoma, a rare aggressive cancer originating in connective tissues, can affect both children and adults. It is particularly challenging to conduct clinical trials due to its rarity. Patients with sarcoma are best managed at the few specialised sarcoma centres in Australia.