Emerging Phase III Results Show CALQUENCE Regimen Significantly Improved Progression-free Survival in Leukemia Patients
AstraZeneca’s CALQUENCE (acalabrutinib) in combination with venetoclax, with or without obinutuzumab achieved the significant and clinically meaningful improvement in the AMPLIFY Phase III trial.
AstraZeneca has shared positive, interim results from the AMPLIFY Phase III trial (NCT03836261) evaluating its CALQUENCE (acalabrutinib) in combination with venetoclax, with or without obinutuzumab in previously untreated adult patients with chronic lymphocytic leukemia (CLL). The regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy.1
In a press release, Jennifer R. Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and the Worthington and Margaret Collette Professor of Medicine at Harvard Medical School, and principal investigator of the trial, said: “The AMPLIFY results demonstrate the potential of acalabrutinib and venetoclax with or without obinutuzumab to be effective and well-tolerated fixed-duration treatment options for patients with chronic lymphocytic leukemia. This is an important advance in this setting as fixed-duration regimens allow those living with this chronic disease to take breaks from their treatment, thereby decreasing the possibility of long-term adverse events and drug resistance and improving quality of life.”
According to AstraZeneca, the regimen did show a favorable trend for the trial’s secondary endpoint of overall survival (OS), but the data were not mature at the time of this most recent analysis. The trial will continue to assess OS as a key secondary endpoint.
Safety and tolerability of the medicines were consistent with their known safety profiles. Data showed that no new safety signals were identified, with low rates of cardiac toxicity observed.
The Phase III AMPLIFY trial is a randomized, global, multi-center, open-label study. Patients were randomized 1:1:1 to receive either CALQUENCE in combination with venetoclax, CALQUENCE in combination with venetoclax plus obinutuzumab for a fixed duration or standard-of-care chemoimmunotherapy.
“The progression-free survival and overall survival results from the AMPLIFY Phase III trial demonstrate the potential of including a BTK inhibitor in a fixed-duration regimen and reinforce our leadership in advancing science for patients with chronic lymphocytic leukemia. If approved, CALQUENCE would become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, providing more options for patients and their healthcare providers,” Susan Galbraith, executive vice president, oncology R&D, AstraZeneca added in the press release.
Earlier in May, AstraZeneca shared positive Phase III data that showed CALQUENCE in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, demonstrated a statistically significant and clinically meaningful improvement in PFS versus standard of care in previously untreated adult patients with mantle cell lymphoma (MCL).2
These results emerged from the ECHO Phase III trial (NCT02972840), which is a randomized, double-blind, placebo-controlled, multi-center study. In the experimental arms, patients were randomized 1:1 to receive either CALQUENCE or placebo administered orally twice per day, on 28 day treatment cycles, plus bendamustine on days 1 and 2 and rituximab on day 1. Following six cycles of CALQUENCE or placebo in combination with bendamustine and rituximab, patients receive CALQUENCE or placebo plus maintenance rituximab for two years and then either CALQUENCE or placebo only until disease progression.
For CALQUENCE in combination with venetoclax, with or without Obinutuzumab, AstraZeneca plans to share additional data at an upcoming medical conference.
References
1. Fixed-duration CALQUENCE® (acalabrutinib) plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival in 1st-line chronic lymphocytic leukemia in AMPLIFY Phase III trial. News release. AstraZeneca. July 29, 2024. Accessed July 30, 2024. https://www.businesswire.com/news/home/20240729312862/en/Fixed-duration-CALQUENCE%C2%AE-acalabrutinib-plus-venetoclax-with-or-without-obinutuzumab-significantly-improved-progression-free-survival-in-1st-line-chronic-lymphocytic-leukemia-in-AMPLIFY-Phase-III-trial
2. Calquence combination regimen demonstrated statistically significant and clinically meaningful improvement in progression-free survival in 1st-line mantle cell lymphoma in ECHO Phase III trial. News release. AstraZeneca. May 2, 2024. Accessed July 30, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/calquence-combination-improved-pfs-in-1l-mcl.html
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