AstraZeneca has reported positive interim results from the Phase III ELEVATE-TN trial evaluating Calquence (acalabrutinib) for previously untreated chronic lymphocytic leukaemia (CLL).

The trial met its primary endpoint of progression-free survival (PFS) improvement in patients treated with Calquence, compared to those on the chemotherapy based chlorambucil and obinutuzumab combination.

The trial also met a key secondary endpoint that saw improved PFS in patients treated with Calquence monotherapy compared to a chemotherapy plus obinutuzumab combination.

The safety and tolerability of Calquence during the ELEVATE-TN trial was observed to be consistent with its established profile.

This is the second Phase III trial to yield positive results for the drug, after the Phase III Ascend trial met its primary endpoint of improvement in PFS with Calquence monotherapy, compared to a combination of rituximab and idelalisib or bendamustine.

AstraZeneca oncology research and development (R&D) executive vice-president José Baselga said: “These findings confirm the superiority of Calquence as a monotherapy and also in combination over standard-of-care treatments for chronic lymphocytic leukaemia.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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

Calquence is a Bruton tyrosine kinase (BTK) inhibitor being developed to treat a variety of B-cell blood cancers such as CLL. Currently, it has approval for relapsed or refractory mantle cell lymphoma (MCL).

The randomised, multi-centre, open-label ELEVATE-TN trial investigated the drug’s safety and efficacy in a total of 535 patients.

In addition to PFS, the trial has been designed to track objective response rate, time to next treatment and overall survival.