WORLD’S FIRST PATIENT TO LANDMARK BREAST CANCER CLINICAL TRIAL

An Australian woman has become the world’s first patient to be enrolled in an international breast cancer clinical trial, which will be testing the anti-tumour activity of a new drug called KEYTRUDA when combined with trastuzumab.

KEYTRUDA is part of a class of drugs called immunotherapies, which helps the immune system destroy cancer cells. It has already shown positive results in the treatment of melanoma, lung cancer and other types of cancer. Trastuzumab is currently used in the treatment of HER2 positive breast cancer. However the combined use of these drugs has not yet been tested.

The PANACEA clinical trial (IBCSG 45-13) is for women diagnosed with advanced HER2 positive breast cancer, which aims to find out the most suitable dose of KEYTRUDA (pembrolizumab, MK-3475) and trastuzumab when these drugs are used together and to assess if their combined use is an effective anti-cancer treatment.

PANACEA is a global clinical trial which is being coordinated in Australia by the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG). The ANZBCTG is the largest independent oncology clinical trials research group in Australia and New Zealand and for more than 35 years it has conducted a national clinical trial research program for the treatment, prevention and cure of breast cancer. The study is being led by the International Breast Cancer Study Group (IBCSG) under the Breast International Group (BIG) umbrella.

Associate Professor Sherene Loi from the Peter MacCallum Cancer Centre is the International Study Chair for the PANACEA clinical trial and says the enrolment of the first woman to the study demonstrates the commitment of local researchers to improving treatment options available to women.

“Australian researchers are committed to high quality clinical trials research, which has led to significant improvements to breast cancer survival rates over the last 20 years. Given the success of KEYTRUDA in the treatment of other cancers, we are hopeful that the PANACEA clinical trial will also benefit women diagnosed with advanced HER2 positive breast cancer.”

Trastuzumab and KEYTRUDA are monoclonal antibodies. Naturally occurring antibodies are made by the body to protect against infection by attacking foreign substances. A monoclonal antibody is a laboratory-produced antibody that is carefully engineered to mimic the antibodies that are naturally produced as part of the immune system’s response to germs, vaccines, and other invaders.

“KEYTRUDA is a monoclonal antibody that works against a protein called PD-1 found on the surface of immune cells surrounding tumor cells. It is thought that cancer cells produce other proteins, such as PD-L1 and PD-L2, which bind to PD-1 on immune cells and suppress the ability of the immune system to kill cancer cells. The drugs trastuzumab and KEYTRUDA are being tested together to see if they can inhibit the binding of proteins, such as PD-L1 and PD-L2, to PD-1 in breast cancer, thus reactivating the body’s immune system to identify and kill breast tumour cells,” said Associate Professor Loi.

The ANZBCTG is Australia’s national breast cancer research group dedicated entirely to breast cancer research through the conduct of multi-institution and international clinical trials. The research program involves more than 700 members at over 80 leading medical institutions in Australia and New Zealand. The ANZBCTG’s fundraising department is the Breast Cancer Institute of Australia.

More information about the PANACEA clinical trial (IBCSG 45-13) can be found at https://clinicaltrials.gov/ct2/show/NCT02129556?term=PANACEA&rank=2. Information about the ANZBCTG and its research program is available at www.anzbctg.org.

Media contact: To arrange an interview with Associate Professor Sherene Loi, please contact – Media contact: Anna Fitzgerald, ANZBCTG Communications Manager

Phone: 02 4925 5255 or 0400 304 224 or Email: anna.fitzgerald@anzbctg.org