Acalabrutinib (Calquence) significantly prolonged the time patients lived without disease progression or death in previously untreated chronic lymphocytic leukaemia

Full results from Phase III ELEVATE TN trial showed 93% of patients on acalabrutinib combined with obinutuzumab vs 47% of patients on chlorambucil plus obinutuzumab remained free of disease progression or death at 24 months¹

Trial also showed 87% of patients on acalabrutinib alone remained free of disease progression or death at 24 months¹

[Luton, UK, 07 December 2019] - AstraZeneca today presented results from the interim analysis of the Phase III ELEVATE TN trial, showing that acalabrutinib combined with obinutuzumab or as monotherapy significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated chronic lymphocytic leukaemia (CLL).¹

The Independent Review Committee (IRC)-assessed results were presented at the 2019 American Society of Hematology Annual Meeting and Exhibition in Orlando, US. At a median follow-up of 28.3 months, acalabrutinib in combination with obinutuzumab or as monotherapy significantly reduced the risk of disease progression or death by 90% and 80%, respectively, vs. chlorambucil plus obinutuzumab.¹

In an exploratory analysis, acalabrutinib in combination or alone demonstrated consistent PFS improvements across most pre-specified subgroups of patients with high-risk disease characteristics, including the unmutated immunoglobulin heavy-chain variable gene (IGHV), del(11q) and complex karyotype. Overall, the safety and tolerability profile of acalabrutinib observed in the ELEVATE TN trial was consistent with its known profile.¹

Dr Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE TN trial, said: “In the detailed results from the ELEVATE TN trial comparing acalabrutinib to a commonly used chemo-immunotherapy treatment regimen, acalabrutinib demonstrated a clinically meaningful improvement in progression-free survival, while maintaining its known tolerability and safety profile. These are encouraging results for a patient population that is known to face multiple comorbidities, and where tolerability is a critical factor in their treatment.”

Dr George Follows, Clinical Lead for Lymphoma and CLL, Cambridge University Hospitals NHS Foundation Trust, and investigator of the ELEVATE trial, said: “We were very pleased that Cambridge patients who required first line treatment for CLL were able to participate in the ELEVATE clinical trial to investigate acalabrutinib, an investigational medicine that specifically switches off active growth signalling in leukaemia cells. In this study, patients randomized to receive acalabrutinib either alone or with obinutuzumab had a very high chance of achieving a clinical remission, which was significantly more durable when compared with patients treated with the standard chemotherapy-based treatment. Indeed, the primary endpoint of the study was met with 93% of patients who received acalabrutinib plus obinutuzumab still in remission at 2 years compared with 47% of patients treated with the chemotherapy. Acalabrutinib was generally well tolerated, with around 10% of patients stopping treatment because of side effects over 28 months of follow-up. These promising data are encouraging and show the potential for acalabrutinib as a possible future treatment option for our patients with chronic lymphocytic leukaemia.”

Summary of key efficacy results as assessed by IRC from the ELEVATE TN trial at a median follow-up of 28.3 months:¹