Acalabrutinib Plus Venetoclax Fixed-Duration Regimen Approved in the EU for First-Line CLL Treatment

On June 6, AstraZeneca announced acalabrutinib and venetoclax(Combined or not combined with Obinutuzumab)Fixed course of treatment regimenHas been approved in the EU,For the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL)。

Source: AstraZeneca official website, same as below

The approval is mainly based onPivotal Phase IIIAMPLIFY Study Results. This is a randomized, global, multi-center, open-label Phase III clinical trial designed to evaluate acalabrutinib + venetoclax ± obinutuzumab versus investigator’s choice of chemoimmunotherapy.Efficacy and Safety in Previously Untreated Adult CLL Patients Without del(17p) or TP53 Mutation. The primary endpoint of the study isAs assessed by the Independent Review Committee (IRC)PFS of the Acalabrutinib + Venetoclax Group.

The results showed,Acalabrutinib + Venetoclax Group77% of patients were progression-free within three years.Acalabrutinib + Venetoclax + ObinutuzumabThe proportion was 83%, compared to 67% in patients treated with standard chemoimmunotherapy. The median progression-free survival (PFS) was not reached, while it was 47.6 months for chemoimmunotherapy.

Compared with standard-of-care chemotherapy immunotherapy, acalabrutinib + venetoclax reduced the risk of disease progression or death by 35%.（HR=0.65；95%CI：0.49-0.87；P=0.0038），Acalabrutinib + Venetoclax + Obinutuzumab Can Reduce the Risk of Disease Progression or Death by 58%（HR 0.42；95% CI 0.30-0.59；p<0.0001）。

AcalabrutinibSafety and TolerabilityConsistent with its known safety profile, no new safety signals were identified.

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