{"id":13308,"date":"2019-05-07T14:24:12","date_gmt":"2019-05-07T12:24:12","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=13308"},"modified":"2019-05-07T14:25:47","modified_gmt":"2019-05-07T12:25:47","slug":"astrazenecas-calquence-phase-iii-ascend-trial-met-primary-endpoint","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/astrazenecas-calquence-phase-iii-ascend-trial-met-primary-endpoint\/","title":{"rendered":"AstraZeneca&#8217;s Calquence Phase III ASCEND trial met primary endpoint"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">AstraZeneca today announced positive results from the Phase III ASCEND trial of&nbsp;<em>Calquence<\/em>&nbsp;(acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL). Results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with&nbsp;<em>Calquence<\/em>&nbsp;monotherapy compared to a combination regimen of rituximab plus physician\u2019s choice of idelalisib or bendamustine. Importantly, the safety and tolerability of&nbsp;<em>Calquence<\/em>&nbsp;was consistent with the known profile.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Jos\u00e9 Baselga, Executive Vice President, R&amp;D Oncology said: \u201c<em>Calquence<\/em>&nbsp;is the first BTK inhibitor to show benefit in a Phase III trial as a monotherapy compared to current standard-of-care combinations used in relapsed or refractory chronic lymphocytic leukaemia. We look forward to presenting detailed results at a forthcoming medical meeting.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Within AstraZeneca\u2019s robust development programme for&nbsp;<em>Calquence,<\/em>&nbsp;ASCEND is the first of two Phase III CLL trials expected to read out in 2019. The second is ELEVATE-TN (ACE-CL-007) in treatment-na\u00efve, front-line CLL.&nbsp;<em>Calquence<\/em>&nbsp;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 CLL and other blood cancers.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About ASCEND<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of&nbsp;<em>Calquence<\/em>&nbsp;in previously-treated patients with CLL. In the trial, 310 patients were randomised (1:1) into two groups. Patients in the first group received&nbsp;<em>Calquence<\/em>&nbsp;monotherapy (100mg twice daily until disease progression). Patients in the second group received rituximab plus physician\u2019s choice of idelalisib or bendamustine.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The primary endpoint is PFS assessed by an independent review committee (IRC), and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient reported outcomes and time to next treatment (TTNT).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About&nbsp;<em>Calquence<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Calquence<\/em>&nbsp;(acalabrutinib) was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Calquence<\/em>&nbsp;is an inhibitor of Bruton tyrosine kinase (BTK).&nbsp;<em>Calquence<\/em>&nbsp;binds covalently to BTK, thereby inhibiting its activity<sup>2<\/sup>. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating&nbsp;<em>Calquence<\/em>in 26 clinical trials that are company-sponsored.&nbsp;<em>Calquence<\/em>&nbsp;is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrom macroglobulinaemia, follicular lymphoma, and multiple myeloma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating&nbsp;<em>Calquence<\/em>&nbsp;vs. ibrutinib in previously-treated CLL and ACE-CL-311 evaluating&nbsp;<em>Calquence<\/em>&nbsp;in combination with venetoclax and obinutuzumab in previously-untreated fit patients with CLL.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Source: <a href=\"https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2019\/calquence-phase-iii-ascend-trial-met-primary-endpoint-at-interim-analysis-in-relapsed-or-refractory-chronic-lymphocytic-leukaemia-and-will-stop-early-07052019.html\">AstraZeneca<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>AstraZeneca today announced positive results from the Phase III ASCEND trial of&nbsp;Calquence&nbsp;(acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL). Results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with&nbsp;Calquence&nbsp;monotherapy compared to a combination regimen of rituximab plus physician\u2019s choice of idelalisib or bendamustine. Importantly, the safety and tolerability of&nbsp;Calquence&nbsp;was consistent with the [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-13308","post","type-post","status-publish","format-standard","hentry","category-gezondheid"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AstraZeneca&#039;s Calquence Phase III ASCEND trial met primary endpoint - hollandbio<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hollandbio.nl\/en\/nieuws\/astrazenecas-calquence-phase-iii-ascend-trial-met-primary-endpoint\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AstraZeneca&#039;s Calquence Phase III ASCEND trial met primary endpoint - hollandbio\" \/>\n<meta property=\"og:description\" content=\"AstraZeneca today announced positive results from the Phase III ASCEND trial of&nbsp;Calquence&nbsp;(acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL). Results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with&nbsp;Calquence&nbsp;monotherapy compared to a combination regimen of rituximab plus physician\u2019s choice of idelalisib or bendamustine. 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