New “all-tablet” treatment advance for common form of leukaemia
05 February 2025
An international study published today in the New England Journal of Medicine provides hope for chronic lymphocytic leukaemia (CLL) patients with a new all-tablet treatment showing impressive results.
The AMPLIFY clinical trial included over 800 never-before-treated CLL patients, across 27 countries, and compared a standard chemotherapy-based treatment to a new all-tablet approach.
Standard chemotherapy treatments for CLL, plus the immunotherapy treatment rituximab, require patients to undergo a lengthy infusion and can cause prolonged immune suppression and other unpleasant side-effects.
“Our study indicates a new treatment combination of two or three targeted therapies - acalabrutinib-venetoclax, with or without obinutuzumab - can significantly prolong progression free survival compared to the previous standard chemotherapy treatment regimens,” says Professor John Seymour, Director of Haematology at Peter MacCallum Cancer Centre and the Royal Melbourne Hospital.
“These results are very encouraging with the overall survival at 36 months being significantly better with this all-tablet combination compared to chemotherapy treatments.
"It shows the potential to achieve better outcomes for patients through a simple tablet-based therapy, rather than requiring them to come to hospital and receive their treatment via an infusion.”
Prof Seymour said another all-tablet approach in CLL - using a different drug called ibrutinib - was approved in Australia however this was “associated with a concerning risk of heart complications which are much less frequent with the acalabrutinib-venetoclax combination”.
The trial also observed CLL patients with a disease profile called “uIGHV” which is generally associated with poorer outcomes compared to patients with the “mutated IGHV” profile.
“These patients had equivalent outcomes with the new combination, identifying this group as one that particularly benefits,” Prof Seymour says.
“When obinutuzumab treatment was added to the uIGHV group they had a progression-free survival similar to the group with mutated IGHV patients, which is promising in this hard-to-treat cancer group. It was also reassuring to observe similar side-effect profiles for all the treatments with the majority being readily manageable.
“This really is wonderful news for fit, treatment naive CLL patients and once this combination receives PBS-funding in Australia, we look forward to being able to offer them this safe and effective all-oral, fixed-duration regimen to reduce the burdens of therapy in the near future.”
CLL is a blood cancer that affects white blood cells called lymphocytes. It is the most common leukaemia in Australia, with approximately 1000 Australians diagnosed each year. These study results were also presented at the American Society of Haematology meeting in San Diego in December last year.
The paper is titled “Fixed-Duration Acalabrutinib Combinations in Untreated Chronic Lymphocytic Leukemia” and you rean read it in full here.
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