Ascentage Pharma has entered a clinical collaboration to jointly conduct a Phase III study of the Bcl-2 inhibitor APG-2575 (lisaftoclax) together with AstraZeneca’s Bruton’s tyrosine kinase inhibitor CALQUENCE (acalabrutinib) in treatment-naïve patients suffering with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).

The international, randomised-controlled, multi-centre, open-label, registrational study will assess the safety and efficacy of the combined therapy against immunochemotherapy in treatment-naive CLL/SLL patients.

A global Phase II study of the combined therapy was previously conducted in June 2020. The study was jointly conducted by Ascentage and AstraZeneca Group’s research and development centre Acerta Pharma.

In the Phase II study, the efficacy, safety, and tolerability of the combined therapy were evaluated.

An objective response rate (ORR) of 98% was achieved in relapsed/refractory (R/R) CLL/SLL patients, an ORR of 100% in treatment-naive patients with CLL/SLL, and an excellent safety profile was observed when lisaftoclax was used as monotherapy.

AstraZeneca China Medical Affairs head and vice president Haiying Yang said: “Phase III results from the ASCENT, ELEVATE-TN, and ELEVATE-RR trials have solidified AstraZeneca’s position in the haematology field, while acalabrutinib-based combination regimens have been widely adopted as standard of care treatments.

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.

“We are confident that acalabrutinib-based combinations can bring more effective and precision-targeting therapies to patients with hematologic malignancies in China as we take further steps in rendering haematologic malignancies into manageable chronic conditions.

“Through these innovative partnerships with local Chinese companies, we aspire to expand to more therapeutic areas and bring clinical benefit to a broader population of cancer patients in China.”

In China, acalabrutinib was approved this year for treating patients with mantle cell lymphoma and CLL/SLL who earlier received at least one therapy.

Acalabrutinib was also approved in more than 50 countries, including Japan, and the European Union.

Lisaftoclax selectively blocks the antiapoptotic protein Bcl-2 and restores the normal apoptosis process in cancer cells.

At present, lisaftoclax is being assessed in several clinical studies globally and more than 300 CLL/SLL patients received treatment with this drug.