ELEVATE-TN: Impact of first-year dose modifications in treatment-naive CLL patients treated with acalabrutinib

Prof George Follows, a consulting haematologist from Nuffield Health Cambridge Hospital, presents a post-hoc analysis of the ELEVATE-TN trial, a prospective, randomized study involving treatment-naïve elderly CLL patients. Patients were assigned to receive either acalabrutinib monotherapy or a combination of acalabrutinib with obinutuzumab, compared to the standard arm of obinutuzumab plus chlorambucil.

This poster specifically delves into the performance of patients based on dose reductions during the first year of treatment. Patients were categorized into four groups, ranging from those without dose reductions and treatment breaks to those who, for various reasons, were unable to continue acalabrutinib. An encouraging finding regarding OS emerged, indicating that over a 4-5-6 year follow-up period, OS remains largely consistent when patients can resume acalabrutinib treatment. The implication is that if a patient is medically fit to resume the drug, there is minimal compromise in terms of OS, notwithstanding dose reductions or treatment interruptions.

Notably, 80% of patients in this trial did not experience dose reductions or treatment breaks. Among them, half received additional obinutuzumab during the first year, and this subgroup exhibited a distinct, statistically significant survival advantage.

Although the overall 6 year survival outcome for all patients did not reach statistical significance, clinical observations suggest that considering the addition of obinutuzumab to acalabrutinib for patients who are deemed medically fit is a worthwhile consideration in practice.

Reference:

Follows G, ASH2023. #4645

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