UK-based pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) announced that the European Commission (EC) has approved its fixed-duration regimen of Calquence (acalabrutinib) combined with Venclexta (venetoclax), with or without Gazyva (obinutuzumab), for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL).
Clinical Trial Results
The decision was supported by positive results from the Phase III AMPLIFY study. The study demonstrated that 77% of patients treated with Calquence plus venetoclax and 83% of patients treated with Calquence plus venetoclax and obinutuzumab were progression-free at three years. This compares to 67% of patients treated with standard-of-care chemoimmunotherapy. Median progression-free survival (PFS) was not reached in either combination arm, compared to 47.6 months for chemoimmunotherapy. Calquence plus venetoclax reduced the risk of disease progression or death by 35%, while Calquence plus venetoclax with obinutuzumab achieved a 58% risk reduction.
Expert Insights and Safety Profile
Barbara Eichhorst, an investigator in the AMPLIFY trial, highlighted that fixed-duration therapy helps reduce long-term side effects and drug resistance while improving patient adherence. Calquence demonstrated a consistent safety and tolerability profile with no new safety signals.-Fineline Info & Tech
