PROMISING RESULTS FOR CHARIOT CLINICAL TRIAL

The addition of dual immunotherapy treatment to standard chemotherapy has shown promising results in patients with treatment resistant, early-stage triple negative breast cancer.

The CHARIOT clinical trial investigated if using two immunotherapy drugs (nivolumab and ipilimumab) together with standard chemotherapy (paclitaxel) before surgery, was safe and effective and could stimulate the body’s immune system to kill the cancer cells. And, if continuing treatment with one of these drugs (nivolumab) after surgery can keep the immune system active to eradicate any residual cancer cells.

This was a world-first Australian clinical trial developed by Breast Cancer Trials (BCT) researchers, which recruited 34 patients at eight participating institutions throughout Australia.

CHARIOT was open to both women and men diagnosed with triple negative early breast cancer demonstrated to be resistant to traditional neoadjuvant chemotherapy treatments. Patients whose triple negative breast cancer is resistant to chemotherapy and have evidence of residual cancer in the breast after neoadjuvant chemotherapy have a high chance of relapse and death from breast cancer within three years.

Primary results of the CHARIOT clinical trial were presented at the American Society of Clinical Oncology (ASCO) international conference in 2022. Those results showed the addition of nivolumab and ipilimumab resulted in a promising response rate with 24% of participants achieving a complete disappearance of their cancer within the breast and lymph nodes by the time of surgery but longer term follow up was needed to determine the overall effectiveness of this treatment.

The three-year follow up results for CHARIOT have now been presented at the American Society of Clinical Oncology (ASCO) international conference in June 2024.

The results showed that participant who achieved complete disappearance of their cancer within the breast and lymph nodes at the time of surgery were less likely to have a breast cancer recurrence and had better overall survival. Importantly, 100% of participants whose breast cancer showed an increased presence of PD-L1 (known as PD-L1 positive) and, or a high number of tumour infiltrating lymphocytes (TILs) were alive and free from any breast cancer at 3 years.

Professor Sherene Loi is the Study Chair of the CHARIOT clinical trial, Board Director at BCT and Head of the Translational Breast Cancer Genomics and Therapeutics Laboratory at the Peter MacCallum Cancer Centre.

“These results demonstrate that for those women who have complete disappearance of their cancer by the time they have surgery are more likely to experience enduring long term breast cancer free survival,” Professor Loi said.

“While the patient numbers in this trial are few, we are very excited to see the breast cancer free and overall survival for those whose breast cancer is PD-L1 positive and or have high TILs impressive and warrants further research.”

Founded in 1978, Breast Cancer Trials conducts a multicentre national and international clinical trials research program, for the treatment and prevention of breast cancer. Supported by the generosity of donors and other funding bodies, the research program involves 980 researchers in 118 institutions across Australia and New Zealand.

Contact: BCT Communications Manager, Anna Fitzgerald – 0400 304 224 or anna.fitzgerald@bctrials.org.au

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