AstraZeneca reports positive test results, new approval for 'Calquence'
AstraZeneca said on Monday that positive high-level results from the ‘ELEVATE-RR’ phase 3 trial showed ‘Calquence’, or acalabrutinib, met its primary endpoint, demonstrating non-inferior progression-free survival for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib.
The FTSE 100 drugmaker said the trial also met a key secondary endpoint for safety, showing patients treated with Calquence had statistically significantly lower incidence of atrial fibrillation compared to patients treated with ibrutinib.
It described atrial fibrillation as an irregular heart rate that could increase the risk of stroke, heart failure and other heart-related complications.
Further hierarchical testing revealed no difference for grade three or higher infections or Richter's transformation.
There was a descriptive trend for numerically favourable overall survival, and overall, the safety and tolerability of Calquence was consistent with the profile seen in the broader Calquence clinical development programme.
AstraZeneca said ELEVATE-RR was the first phase 3 trial to compare two Bruton's tyrosine kinase inhibitors in patients with CLL, the most common type of leukaemia in adults.
Patients diagnosed with high-risk CLL could experience rapid worsening of their disease, requiring treatment.
“With over 40 months of follow-up, today's results confirm that Calquence, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy,” said executive vice-president of oncology research and development José Baselga.
“The totality of the data confirm our confidence in the favourable benefit-risk profile of Calquence.”
At the same time, AstraZeneca confirmed that Calquence had been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia, including small lymphocytic lymphoma (SLL).
The company said the approval from the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ‘ASCEND’ phase 3 trial and a phase 1 trial in Japanese patients, showing Calquence monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival when compared to a standard treatment of rituximab, a monoclonal antibody, combined with the physician's choice of idelalisib, a PI3-kinase inhibitor or bendamustine, a chemotherapy.
It said that in the ASCEND trial, Calquence reduced the risk of disease progression or death by 69%, with the results published in Journal of Clinical Oncology in 2020.
It said CLL is the most common type of adult leukaemia across the globe but considered a rare disease in Japan and East Asia, representing between 1% and 2% of patients diagnosed with leukaemia.
“Chronic lymphocytic leukaemia is less prevalent in Japan than other regions, yet patients remain in need of innovative treatment options,” said executive vice-president of the oncology business unit, Dave Fredrickson.
“This approval of Calquence offers patients in Japan a new, chemo-free, tolerable treatment option with uncompromised efficacy and the potential to positively impact quality of life.”
At 0807 GMT, shares in AstraZeneca were up 0.73% at 7,834p.