{"id":1798,"date":"2020-05-13T09:47:44","date_gmt":"2020-05-12T20:47:44","guid":{"rendered":"https:\/\/clladvocates.nz\/?p=1798"},"modified":"2020-05-13T09:47:44","modified_gmt":"2020-05-12T20:47:44","slug":"study-findings-support-long-term-efficacy-and-safety-of-acalabrutinib-in-r-r-cll","status":"publish","type":"post","link":"https:\/\/clladvocates.nz\/?p=1798","title":{"rendered":"Study Findings Support Long-Term Efficacy and Safety of Acalabrutinib in R\/R CLL"},"content":{"rendered":"

[vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”3″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″][vc_column width=”1\/1″][vc_custom_heading heading_semantic=”h1″ text_size=”h1″]<\/p>\n

Study Findings Support Long-Term Efficacy and Safety of Acalabrutinib in R\/R CLL<\/h1>\n

[\/vc_custom_heading][vc_column_text]Long-term follow-up of a phase 1\/2 study demonstrated durable efficacy and safety of acalabrutinib monotherapy in patients with relapsed\/refractory chronic lymphocytic leukemia\/small lymphocytic leukemia (CLL\/SLL), according to results published in\u00a0Blood<\/em>.1<\/sup><\/p>\n

Acalabrutinib, an oral selective Bruton tyrosine kinase (BTK) inhibitor, was approved in November 2019 by the US Food and Drug Administration (FDA) at a dose of 100 mg twice daily for the treatment of adult patients with CLL\/SLL.2<\/sup><\/p>\n

This analysis included updated results from the initial phase 1\/2 study of acalabrutinib in an expanded cohort of 134 adult patients with relapsed\/refractory CLL\/SLL with a median age of 66 years (ClinicalTrial.gov Identifier:\u00a0NCT02029443<\/a>) followed for a median of 41 months. While patients initially received acalabrutinib at a dose of either 200 mg once daily or 100 mg twice daily, only the latter dose of acalabrutinib was administered following a study amendment in May 2015 based on results of pharmacodynamics studies.<\/p>\n

At data cutoff, more than half of study patients were still receiving acalabrutinib, with 21% of patients discontinuing acalabrutinib therapy due to progressive disease.<\/p>\n

Overall response rate (ORR), including patients achieving a complete response, a partial response. or a partial response with lymphocytosis (PRL) was 94%, with PRL as best response in 6% of patients. Of note, ORR was 90% or higher in the subgroups of patients with disease characterized by del(17)(p13.1), \u2028del(11)(q22.3), unmutated immunoglobulin heavy variable (IGHV<\/em>) genes, and complex karyotype characterized by 3 or more abnormalities. In addition, median duration of response (DOR) was not reached, with 45-month DOR estimated at 63% for those with PRL or better.<\/p>\n

Median progression-free survival (PFS) for the overall study population was not reached at the time of the analysis, with 45-month PFS estimated at 62%. In the subgroups of patients with disease characterized by del(17)(p13.1), unmutated\/mutated\u00a0IGHV<\/em>, complex karyotype, and del(11)(q22.3), median PFS was 36 months, not reached, 33 months, and not reached, respectively.<\/p>\n

Regarding safety, grade 3 or higher adverse events occurred in 66% of patients, including neutropenia, pneumonia, hypertension, anemia, and diarrhea in 14%, 11%, 7%, 7%, and 5% of patients, respectively.<\/p>\n

Eleven percent of patients discontinued acalabrutinib as a result of one or more adverse events. Adverse event-related death was reported in 7.5% of patients, with half of these attributed to pneumonia.<\/p>\n

Atrial fibrillation of any grade occurred in 7% patients, with approximately 3% experiencing atrial fibrillation of at least grade 3. Major bleeding classified as grade 3 or higher, serious, or involving the CNS, was reported in 5% percent of patients.<\/p>\n

\u201cNotably, acalabrutinib with follow-up beyond 4 years has shown a decreased frequency of [adverse events] over time and no long-term safety issues to date,\u201d the study authors noted.<\/p>\n

In their concluding remarks, they further commented that \u201cthis updated and expanded study confirms the efficacy, durability of response, and long-term safety of acalabrutinib, justifying its further investigation in previously untreated and treated patients with\u00a0CLL\/SLL<\/a>.\u201d<\/p>\n

References<\/strong><\/p>\n

    \n
  1. Byrd\u00a0JC, Wierda WG, Schuh A, et al.\u00a0Acalabrutinib monotherapy in patients with relapsed\/refractory chronic lymphocytic leukemia: updated phase 2 results<\/a>.\u00a0Blood.<\/em>\u00a02020;135:1204-1213.<\/li>\n
  2. Acalabrutinib (Calquence\u00ae<\/sup>) [package insert]. 2019. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.<\/li>\n<\/ol>\n

    Originally published on Cancer Therapy Advisor<\/a>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

    Long-term follow-up of a phase 1\/2 study demonstrated durable efficacy and safety of acalabrutinib monotherapy in patients with relapsed\/refractory chronic lymphocytic leukemia\/small lymphocytic leukemia (CLL\/SLL), according to results published in Blood.1<\/p>\n","protected":false},"author":1,"featured_media":1799,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[12],"tags":[],"class_list":["post-1798","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-media"],"jetpack_featured_media_url":"https:\/\/clladvocates.nz\/wp-content\/uploads\/2020\/05\/patientcmlchronicleukemiat_1401904.jpg","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/posts\/1798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1798"}],"version-history":[{"count":1,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/posts\/1798\/revisions"}],"predecessor-version":[{"id":1800,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/posts\/1798\/revisions\/1800"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/media\/1799"}],"wp:attachment":[{"href":"https:\/\/clladvocates.nz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1798"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}