The Australian & New Zealand Children’s Haematology/Oncology Group (ANZCHOG)-sponsored OPTIMISE trial has opened to recruitment today at Sydney Children’s Hospital (SCH) and Queensland Children’s Hospital (QCH), marking a promising advancement in children’s cancer therapies utilising precision medicine.
As a platform trial, OPTIMISE will be able to test the effectiveness of multiple different treatment options for children with high-risk cancers, giving doctors the ability to tailor treatment to what is most likely to benefit each child.
The Australian-led OPTIMISE trial is the first childhood cancer platform trial to be developed, co-ordinated and led from Australia and will lead the way globally for targeted therapies, with the trial also expanding internationally.
Professor David Ziegler, Australian Study Chair, said OPTIMISE is a unique trial and offers great potential for improved treatments in the future.
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“OPTIMISE allows us to access cutting edge therapies through this clinical trial; it allows us to test drugs that have never been available before for children with cancer; and it allows us to use new combinations of drugs that we think will make them even more potent and increase the chance of cure,” Professor Ziegler said.
The OPTIMISE trial will be available for children, adolescents and young adults (from birth to 21 years of age) with solid and Central Nervous System (CNS) tumours, or lymphoma.
The first phase of the trial will enrol between four to 24 children to test the efficacy of paxalisib, an enzyme inhibitor, combined with standard chemotherapy drugs; irinotecan and temozolomide. This will be the first Australian-led clinical trial of paxalisib and the first time this combination of drugs will be tested in children.
OPTIMISE is a companion trial to the Zero Childhood Cancer Precision Medicine Program (ZERO), led by the Children’s Cancer Institute and the Kid’s Cancer Centre at Sydney Children’s Hospital, Randwick.
Since its inception in 2017, the ZERO program has enrolled over 1,400 Australian children spanning all cancer types and risk profiles. This world-leading comprehensive precision medicine program analyses each child’s cancer at a genomic level in the search for targetable genetic alterations that help to define new treatment options.
“We have been able to improve cure rates for children with cancer by conducting clinical trials that continually push boundaries and aim to improve cure rates with less toxicity, and that’s what we are continuing to do here,” Professor Ziegler said.
“The results will not only to help provide better treatment access and outcomes for children now, but to also improve knowledge, accessibility and outcomes for children into the future.”
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OPTIMISE will open in eight Australian children’s cancer centres. Under Australian leadership, the OPTIMISE rial will open internationally, first in Canada, through a partnership with Canadian organisation, C17 Council. The Canadian precision oncology program, PROFYLE, will perform the in-depth genetic profiling for children in Canada. Three trial sites will open across Canada, including the Hospital for Sick Children (Toronto).
Canadian Study Chair, Dr. Daniel Morgenstern said “We are delighted to be collaborating with our Australian colleagues to open this precision oncology platform study which will leverage the strengths of existing paediatric cancer sequencing programmes in both countries to assign patients to novel, targeted therapies. This study will help to make precision oncology a reality for more Australian and Canadian children with cancer and ultimately, we hope, provide new treatment options for those with incurable disease”.
ANZCHOG is the national sponsor for the OPTIMISE trial with trial coordination undertaken by Kids Oncology And Leukaemia triAls (KOALA) at Sydney Children’s Hospital, Randwick.
The OPTIMISE trial has been funded by the Australian Government, through a Medical Research Future Fund (MRFF) grant, with additional support from Kazia Therapeutics as the supplier of paxalisib.
