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Calquence Phase III ELEVATE-TN trial met primary
Calquence Phase III ELEVATE-TN trial met primary.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 3502B AstraZeneca PLC 06 June 2019 \n\nThis announcement contains inside information \n \n6 June 2019 07:00 BST\n \nCalquence Phase III ELEVATE-TN trial met primary endpoint at interim\nanalysis in previously-untreated chronic lymphocytic leukaemia\n \nCalquence alone or in combination significantly increased\nthe time patients lived without disease progression\n \nAstraZeneca today announced positive results from the Phase III ELEVATE-TN trial of Calquence (acalabrutinib) in patients with previously-untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.1 This is the second Calquence pivotal trial in CLL to meet its primary endpoint early, following the positive results of the ASCEND trial, announced in May.\n \nThe trial met its primary endpoint; Calquence in combination with obinutuzumab demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.\n \nThe trial also met a key secondary endpoint showing Calquence monotherapy achieved a statistically-significant and clinically-meaningful improvement in PFS compared to the chemotherapy and obinutuzumab regimen.\n \nThe safety and tolerability of Calquence was consistent with its established profile.\n \nJosé Baselga, Executive Vice President, Oncology R&D said: \"These findings confirm the superiority of Calquence as a monotherapy and also in combination over standard-of-care treatments for chronic lymphocytic leukaemia. The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year.\"\n \nAstraZeneca plans to present detailed results from ELEVATE-TN at a forthcoming medical meeting. Additionally, AstraZeneca will present full results from the Phase III ASCEND clinical trial in relapsed or refractory CLL as a late-breaking abstract at the upcoming European Hematology Association (EHA) Annual Congress on 16 June 2019 (Abstract #LB2606).\n \nCalquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, the UAE, and Qatar and is being developed for the treatment of...