UK-based pharmaceutical company AstraZeneca has reported positive data from the Phase III AMPLIFY clinical trial of Calquence (acalabrutinib) for treating chronic lymphocytic leukaemia (CLL).
The global, multi-centre, open-label trial compared the efficacy and safety of a fixed duration of Calquence (acalabrutinib) in previously untreated adults with CLL.
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The treatment regimen comprised Calquence plus venetoclax and optionally obinutuzumab.
This combination regimen was tested against standard chemoimmunotherapy in patients who did not have del(17p) or TP53 mutations.
Participants were randomised into three groups to receive the Calquence regimen or standard chemoimmunotherapy.
Progression-free survival (PFS) was the trial’s primary endpoint, with the key secondary endpoint being the investigator-assessed PFS.
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By GlobalDataThe trial also evaluated overall survival (OS), event-free survival, overall response rate, duration of response and time to the next treatment as other secondary endpoints.
Results from the study showed a ‘statistically significant and clinically meaningful improvement’ in PFS for patients treated with the Calquence regimen.
While the data for OS showed a favourable trend, it was not mature at the time of analysis and the trial will continue to monitor it as a key secondary endpoint.
The treatment’s safety and tolerability matched the individual medicines’ established safety profiles, with no new safety concerns identified.
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “The progression-free survival and overall survival results from the AMPLIFY Phase III trial demonstrate the potential of including a Bruton tyrosine kinase (BTK) inhibitor in a fixed-duration regimen and reinforce our leadership in advancing science for patients with chronic lymphocytic leukaemia.
“If approved, Calquence would become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, providing more options for patients and their healthcare providers.”
Last month, AstraZeneca reported high-level results from the ADJUVANT BR.31 Phase III trial of Imfinzi (durvalumab) showing that the trial did not meet its primary endpoint.
