Interfant-21 Opens at First Australian Site
Thursday 2 May 2024
Earlier this week, Perth Children’s Hospital became the first Australian site to open Interfant-21, an international phase 3 clinical trial.
Interfant-21 tests a new treatment plan for infants (less than one year of age) with KMT2A-rearranged acute lymphoblastic leukaemia (ALL) or mixed phenotype acute leukaemia. A KMT2A gene rearrangement is a chromosomal abnormality found in leukaemia cells, which are less sensitive to standard treatment and are often associated with poorer outcomes.
The trial will test the immunotherapy drug, blinatumomab, with each infant being given a course early in their treatment plan. A second course of blinatumomab may be given if the infant has a good response to the first course. Interfant-21 expands on an initial study of 30 infants treated with blinatumomab which proved the drug as safe and was shown to improve outcomes. Blinatumomab is approved in Australia by the Therapeutic Goods Administration (TGA) for treating adults and children with relapsed ALL, however it is not yet approved for patients with newly diagnosed ALL.
Treatment of childhood ALL represents one of the success stories of modern medicine, with current five-year overall survival exceeding 90%. This success can largely be attributed to uniform clinical trials conducted by international cooperative groups. Despite this, infants diagnosed remain the exception to this success. Infant ALL is a rare disease and comprises about 4% of childhood ALL. Rearrangements of the KMT2A gene are present in up to 80% of infant ALL cases. Outcomes in this cohort are poor, with the five-year event-free survival currently at less than 40%.
The Interfant study group, formed in 1999, is a global collaboration dedicated towards the study of infants with ALL, comprising all major European paediatric study groups and several outside Europe, including Australia and New Zealand. As is the nature of childhood cancer, and especially for infants, increasing doses for standard chemotherapy treatments hasn’t improved outcomes due to the effect of high toxicity levels of conventional chemotherapy agents, which can often lead to treatment related mortality. This highlights the urgent need to identify innovative therapies, such as the use of the immunotherapy agents like blinatumomab, to improve outcomes for infants with ALL.
“The promising pilot data that has emerged with the use of blinatumomab for infant ALL will be rigorously tested in this phase 3 study and there is strong optimism that it will shift the needle to finally improve outcomes for this aggressive cancer“.
Dr Rishi Kotecha, National Principal Investigator
The Australian and New Zealand Children’s Haematology/Oncology Group (ANZCHOG) is the Australian sponsor of Interfant-21, which will open in eight Australian and two New Zealand sites. Interfant-21 has been jointly funded in Australia by the Medical Research Future Fund (MRFF) and The Kids’ Cancer Project.
ANZCHOG is a non-profit organisation committed to ensuring Australian and New Zealand children receive world-class cancer care. We are the peak professional body for paediatric oncologists and health professionals who care for children with cancer, spearheading national initiatives to enhance clinical care through communication, research, networking and education. We are also the national cooperative clinical trials group for childhood cancer, actively working with trial consortia around the globe to ensure Australian and New Zealand children have the opportunity to access the latest promising cancer treatments.
