AstraZeneca (NYSE: AZN) (STO: AZN) and Acerta Pharma, its haematology research and development centre, said on Monday that results from the Phase Ib/II ACE-CL-003 clinical trial and updated results from the Phase I/II ACE-CL-001 clinical trial revealed that Calquence (acalabrutinib) shows potential as both a monotherapy and given in combination as a treatment for chronic lymphocytic leukaemia (CLL) in multiple settings.

The Phase Ib/II ACE-CL-003 trial included two patient cohorts that were treated with acalabrutinib and obinutuzumab. The primary endpoint of overall response rate was 95% for the 19 patients in the treatment-naïve cohort and 92% for the 26 patients with relapsed or refractory CLL.

At approximately two years median study follow-up, secondary endpoints of response and median progression-free survival had not yet been reached in either patient cohort.

New, longer-term follow-up data was obtained from the Phase I/II ACE-CL-001 clinical trial that investigated the safety (primary endpoint) and efficacy (secondary endpoint) of acalabrutinib as a monotherapy, involving 134 patients with relapsed or refractory CLL.

With a median time on study and follow-up of 24.5 months, overall response rate was 87% while overall response including partial response from lymphocytosis was 93%. Progression-free survival was not yet reached, but based on the Kaplan-Meier estimate, the progression-free survival rate at 18 months was 90%.

The results were presented at the 59th American Society of Haematology (ASH) Annual Meeting and Exhibition which took place in Atlanta.