New data confirms AstraZeneca's confidence in Calquence

AstraZeneca said on Monday that final results from the head-to-head ‘ELEVATE-RR’ phase 3 trial of ‘Calquence’, or acalabrutinib, demonstrated non-inferior progression-free survival (PFS) and statistically significantly fewer events of atrial fibrillation versus ibrutinib in adults with previously-treated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.

The FTSE 100 drugmaker also said that separately, updated results at four years of follow-up from the ‘ELEVATE-TN’ phase 3 trial continued to show a strong progression-free survival benefit for Calquence as combination therapy, or as monotherapy in previously-untreated patients with CLL.

At a median follow-up of 40.9 months, the ELEVATE-RR trial met its primary endpoint of progression-free survival non-inferiority versus ibrutinib with a median progression-free survival of 38.4 months in both arms.

It said patients treated with Calquence had a statistically significantly lower incidence of all-grade atrial fibrillation compared with patients treated with ibrutinib, at 9.4% versus 16.0%, which was a key secondary endpoint.

Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications.

“Tolerability is a critical factor in treating patients with chronic lymphocytic leukaemia who often remain on medicines for many years and experience multiple comorbidities,” said Dave Fredrickson, executive vice-president of AstraZeneca’s oncology business unit.

“The totality of the Calquence data at the American Society of Clinical Oncology (ASCO) confirm our confidence in the favourable benefit-risk profile of this medicine, with over 40 months of follow up in each of these two trials.

“Together, the results provide strong evidence that Calquence is a preferred option for people living with this chronic and devastating disease.”

AstraZeneca said the results of both trials were being presented during the 2021 American Society of Clinical Oncology annual meeting on 7 June.

At 0818 BST, shares in AstraZeneca were down 1.12% at 7,965p.