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AstraZeneca drug for chronic lymphocytic leukaemia successfully navigates phase III trial

The results will “serve as the foundation for regulatory submissions later this year", said AZ’s vice president of oncology, José Baselga
FDA graphic
The AZ drug currently has regulator sign-off to treat mantle cell lymphoma

An AstraZeneca PLC (LON:AZN) drug being developed to treat chronic lymphocytic leukaemia has successfully navigated a phase III clinical trial.

AZ’s Calquence, to use the jargon, demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival. In other words it was proven to help people live longer.

READ: AstraZeneca reports positive results from trial of pancreatic cancer treatment

The primary aim of the study was to assess the treatment in harness with a targeted type of drug called a monoclonal antibody – in this case obinutuzumab.

The comparator group received the current standard of care: chemotherapy coupled with the same antibody treatment.

A secondary goal was to see if Calquence worked on its own, as what is called a monotherapy. The drug ticked both boxes.

The results will “serve as the foundation for regulatory submissions later this year", said AZ’s vice president of oncology, José Baselga.

Chronic lymphocytic leukaemia is the most common type of leukaemia in adults with an estimated 191,000 new cases globally.

Calquence, meanwhile, was granted accelerated approval by the US Food and Drug Administration in autumn 2017 for the treatment of mantle cell lymphoma who have received at least one prior therapy.

In a note to clients, analysts at City broker Shore Capital commented: “Overall, we view this data as encouraging and supportive of consensus forecasts and we look to detailed data from ASCEND and ELEVATE-TN, as well as data versus the market leader Imbruvica (ELEVATE-RR, data 2020F+), for further clarity on the competitive profile of Calquence and before unlocking further value.”

Shore Capital reiterated a ‘buy’ rating on AstraZeneca shares, which in afternoon trading were 1.2% higher at 6,029p.

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