AstraZeneca Plc (NASDAQ:AZN) released data from the ECHO Phase 3 trial of Calquence (acalabrutinib) plus bendamustine and rituximab compared to standard-of-care chemoimmunotherapy (bendamustine and rituximab) in adult patients at or over 65 years of age (n=635) with previously untreated mantle cell lymphoma (MCL).
The data showed that the Calquence combo regime demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
The results will be presented at the European Hematology Association 2024 Hybrid Congress.
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Results showed that the Calquence combination regimen reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Median PFS was 66.4 months for patients treated with the Calquence combination (n=299) versus 49.6 months with standard-of-care chemoimmunotherapy (n=299).
The secondary endpoint of overall survival (OS) showed a favorable trend for the Calquence combination compared to standard-of-care chemoimmunotherapy.
The OS data were not mature at the time of this analysis, and the trial will continue to assess OS.
The ECHO trial enrolled during the pandemic period, and a pre-specified analysis censoring for COVID-19-related deaths was conducted to assess the impact.
PFS was further improved in both arms, with the Calquence combination reducing the risk of disease progression or death by 36%.
Median PFS was not reached among patients treated with the Calquence combination versus 61.6 months for standard-of-care chemoimmunotherapy. A favorable trend was seen for OS in this analysis for the Calquence combination.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The ECHO trial data demonstrate important progress in improving outcomes for patients with mantle cell lymphoma. The 16.8 months of additional time patients can live without their disease progressing is highly clinically meaningful, with a trend to improvement in overall survival.”
Price Action: AZN shares are down 0.45% at $79.23 during the premarket session at last check Monday.
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