AstraZeneca’s Calquence Study: Evaluating Safety in Real-World CLL Treatment

AstraZeneca ((AZN)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.

AstraZeneca’s recent clinical study, titled ‘General Use-Results Study of Calquence Capsules 100 mg in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma),’ aims to evaluate the incidence of adverse drug reactions (ADRs) for Calquence (acalabrutinib) in a real-world, post-marketing setting. This study is significant as it provides insights into the safety profile of Calquence in patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) who have not received prior treatment.

The intervention being tested is Calquence, a 100 mg capsule of acalabrutinib, designed to treat patients with CLL and SLL. The primary purpose of this intervention is to monitor and understand the safety and incidence of ADRs in a post-marketing context.

The study is observational in design, utilizing a cohort model with a prospective time perspective. There is no allocation or intervention model specified, and the primary purpose is to gather observational data on the drug’s safety.

The study began on June 19, 2023, with the primary completion and estimated completion dates yet to be disclosed. The last update was submitted on July 28, 2025, indicating ongoing data collection and analysis.

This update could positively impact AstraZeneca’s stock performance by reinforcing investor confidence in Calquence’s market potential, especially if the safety profile remains favorable. It also positions AstraZeneca competitively within the oncology market, where safety and efficacy are critical for market share.

The study is ongoing, with further details available on the ClinicalTrials portal.