At the 66th American Society of Hematology (ASH) annual meeting, UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) revealed the latest results from the Phase III AMPLIFY study for its drug Calquence (acalabrutinib) in combination with venetoclax for adult patients with chronic lymphocytic leukaemia (CLL).
AMPLIFY Study Design and Findings
The AMPLIFY study aims to assess the efficacy of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, compared to the standard-of-care chemoimmunotherapy in previously untreated adult patients with CLL. With a median follow-up of 41 months, the study showed that Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.65). When obinutuzumab was added to the combination, there was a 58% reduction in the risk of disease progression or death (HR 0.42). The median progression-free survival (PFS) was not reached for either experimental arm, in contrast to a median PFS of 47.6 months for chemoimmunotherapy. The 36-month PFS rates were estimated at 76.5% for Calquence plus venetoclax and 83.1% with the addition of obinutuzumab, compared to 66.5% for chemoimmunotherapy. Overall survival (OS) data were immature at the time of analysis; however, the Calquence combination showed a trend towards OS benefit.
Calquence’s Acquisition and Approval History
AstraZeneca acquired Calquence through a $4 billion purchase of 55% stakes in Acerta Pharma in 2016. The Bruton’s tyrosine kinase (BTK) inhibitor received approval in China in March 2023 for the treatment of mantle cell lymphoma (MCL) patients who have received at least one prior treatment, followed by approval in September for use in adult patients with CLL/small lymphocytic lymphoma (SLL) who have previously received at least one treatment.
Complementary Therapies in China
Venclexta, a B-cell leukemia/lymphoma 2 (Bcl-2) inhibitor by US-based AbbVie, was approved in China in 2020 for the treatment of newly diagnosed adult patients with acute myeloid leukemia (AML). Additionally, Gazyva (obinutuzumab), an anti-CD20 monoclonal antibody (mAb) from Swiss pharmaceutical giant Roche, was approved in China in June 2021 to treat naïve follicular lymphoma (FL).-Fineline Info & Tech
