AstraZeneca’s Calquence has impressed in a Phase III trial assessing its impact on progression-free survival (PFS) in patients with chronic lymphocytic leukaemia (CLL).
According to an interim analysis of the Phase III ELEVATE TN trial, Calquence (acalabrutinib) combined with obinutuzumab or as monotherapy significantly improved PFS versus standard treatment with chlorambucil plus obinutuzumab in patients with previously untreated disease.
The data, presented at the 2019 American Society of Hematology Annual Meeting and Exhibition in Orlando, US, showed that at a median follow-up of 28.3 months, the drug significantly reduced the risk of disease progression or death by 90% and 80%, respectively, vs chlorambucil plus obinutuzumab.
Ninety-three percent of patients on Calquence combined with obinutuzumab vs. 47% of patients on chlorambucil plus obinutuzumab remained free of disease progression or death at 24 months.
Also of note, the safety and tolerability profile of Calquence observed in the ELEVATE TN trial was consistent with its known profile, AstraZeneca said.
Calquence is an inhibitor of Bruton tyrosine kinase (BTK), which bonds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
“On the heels of approvals in the US, Australia and Canada, these full results provide further evidence that Calquence, as a new treatment option for patients with chronic lymphocytic leukaemia, demonstrates remarkable efficacy and a favourable tolerability profile,” said José Baselga, executive vice president, Oncology R&D, at AZ.
“These results also provide, for the first time, post-hoc analysis data exploring the potential progression-free survival benefit of adding obinutuzumab to a BTK inhibitor such as Calquence versus BTK inhibitor monotherapy in a randomised trial.”