AstraZeneca has received the European Commission (EC) approval for fixed-duration regimens of Calquence (acalabrutinib) to treat adults with previously untreated chronic lymphocytic leukaemia (CLL).
Calquence, a second-generation Bruton’s tyrosine kinase (BTK) inhibitor, is already approved in the US, Japan, China, the EU, and other regions for various indications.
The approval is based on positive results from the Phase 3 AMPLIFY trial, which showed significant improvement in progression-free survival for Calquence-based combinations.
AstraZeneca oncology haematology business unit executive vice president Dave Fredrickson said: “Today’s approval brings a new fixed-duration treatment option to patients with previously untreated chronic lymphocytic leukaemia across Europe.
“Calquence plus venetoclax is the first and only all-oral combination treatment option with a second-generation BTK inhibitor approved in the EU and provides patients and their physicians more flexibility in managing this incurable blood cancer.”
AMPLIFY is a randomised, global, multi-centre, open-label Phase 3 clinical trial that assessed the efficacy and safety of Calquence in combination with venetoclax, with or without obinutuzumab, compared to the investigator’s choice of chemoimmunotherapy.
The chemoimmunotherapy included fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab.
Patients were randomised to receive either Calquence plus venetoclax, or Calquence plus venetoclax with obinutuzumab for a fixed duration, or chemoimmunotherapy.
The study showed that 77% of patients treated with Calquence plus venetoclax remained progression-free at three years.
Also, 83% of patients treated with Calquence, venetoclax, and obinutuzumab remained progression-free, compared to 67% of patients on chemoimmunotherapy.
Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy, and the addition of obinutuzumab further reduced the risk by 58%.
The safety profile of Calquence was consistent with previous findings, with no new safety concerns identified.
Regulatory applications for these regimens are under review in several other countries, following the AMPLIFY trial’s results.
Currently, Calquence is being evaluated both as a standalone treatment and in combination with standard chemoimmunotherapy for various B-cell blood cancers.
AMPLIFY trial investigator Barbara Eichhorst said: “For patients diagnosed with chronic lymphocytic leukaemia, this approval provides a new option in the first-line setting that may help to minimise long-term side effects and reduce drug resistance as they may occur with continuous treatment.
“A fixed-duration regimen is appealing to patients and helps with adherence during the treatment period.”
