Therapy Areas: Cardiovascular
AstraZeneca reports meeting of primary end point by Calquence phase III ELEVATE-TN trial
7 June 2019 -

Biopharmaceutical company AstraZeneca Plc (LON:AZN) announced on Thursday positive results from the phase III ELEVATE-TN trial of Calquence (acalabrutinib) in patients with previously-untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.

Reportedly, this is the second Calquence pivotal trial in CLL to meet its primary endpoint early, following the positive results of the ASCEND trial, announced in May 2019.

According to the company, this trial met its primary endpoint of Calquence in combination with obinutuzumab demonstrating a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.

This trial also met a key secondary endpoint showing Calquence monotherapy achieved a statistically-significant and clinically-meaningful improvement in PFS compared to the chemotherapy and obinutuzumab regimen.

The safety and tolerability of Calquence was consistent with its established profile.

These positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year, the company said.

Also, AstraZeneca plans to present detailed results from ELEVATE-TN at a forthcoming medical meeting. In addition, the company will present full results from the phase III ASCEND clinical trial in relapsed or refractory CLL as a late-breaking abstract at the upcoming European Haematology Association (EHA) Annual Congress on 16 June 2019.

Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, the UAE and Qatar and is being developed for the treatment of CLL and other blood cancers.

AstraZeneca is focussed on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.