AstraZeneca has announced that its Phase III ELEVATE-TN trial of Calquence (acalabrutinib) has concluded with positive results.
Calquence is an existing treatment that’s being explored as an option for patients with previously untreated chronic lymphocytic leukaemia (CLL), which is the most common form of blood cancer in adults.
The organisation announced that Calquence in combination with obinutuzumab “demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab”.
Jose Baselga, executive vice president of oncology R&D at AstraZeneca, said that the positive results from this trial, as well as the ASCEND trials that the firm carried out earlier in the year with Calquence, will “form the basis for regulatory submissions later this year”.
He also said that the data from the ELEVATE-TN trial “confirms the superiority of Calquence as a monotherapy and also in combination over standard-of-care treatments for chronic lymphocytic leukaemia”.
The US Food and Drug Administration (FDA) has already granted accelerated approval for Calquence for the treatment of adult patients with mantle cell lymphoma (MCL) who have already had at least one treatment for the condition.
It’s estimated that there are around 191,000 new cases of CLL diagnosed each year, so a new treatment for the disease could have a positive impact on thousands of people.
The NHS notes that the earlier CLL is diagnosed, the better the outcome for the patient. However, the organisation points out that it’s not normally possible to cure CLL, although the condition can be controlled using medication for many years.
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