CLL is a form of B-cell blood cancer. Credit: Prof. Erhabor Osaro via Wikimedia.

AstraZeneca has announced Calquence (acalabrutinib) reached both its primary and secondary endpoints in chronic lymphocytic leukaemia (CLL).

In preliminary analysis of the Phase III ELEVATE-TN trial Calquence in combination with obinutuzumab caused a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to a chemotherapy combination of chlorambucil and obinutuzumab; this was the primary endpoint of the study.

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The drug also reached its secondary endpoint; it demonstrated a statistically significant and clinically meaningful improvement in PFS as a monotherapy compared to the same chemotherapy combination.

Calquence’s safety and tolerability in the ELEVATE-TN trial was consistent with the rest of the drug’s clinical development programme. Full results from the trial will be presented at an upcoming investor meeting.

AstraZeneca Oncology R&D executive vice-president José Baselga said: “These findings confirm the superiority of Calquenceas a monotherapy and also in combination over standard-of-care treatments for chronic lymphocytic leukaemia.

“The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year.”

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Calquence also met its primary endpoint early in the ASCEND trial, results of which were announced in May. In the ASCEND study Calquence was compared to a combination regimen of rituximab plus physician’s choice of idelalisib or bendamustine.

AstraZeneca’s drug showed a statistically-significant and clinically-meaningful improvement in PFS.

In a third ongoing Phase III trial, ELEVATE-RR, Calquence is being investigated in combination with venetoclax in patients with previously-untreated CLL without 17p deletion or TP53 mutation.

Calquence, which is an inhibitor of Bruton tyrosine kinase (BTK), the enzyme that activates B-cells proliferation, trafficking, chemotaxis and adhesion.

The drug is being investigated for a range of B-cell blood cancers, such as diffuse large B-cell lymphoma, Waldenstrom macroglobulinaemia, follicular lymphoma, and multiple myeloma; it has already been approved for relapsed or refractory mantle cell lymphoma in the US, Brazil, the UAE, and Qatar.