{"id":26585,"date":"2020-11-21T07:20:00","date_gmt":"2020-11-21T07:20:00","guid":{"rendered":"http:\/\/aa3b5c16cd1abb5770b0a84c24e71690"},"modified":"2024-11-03T15:16:14","modified_gmt":"2024-11-03T15:16:14","slug":"update-shows-long-term-survival-benefit-with-abemaciclib-plus-fulvestrant-in-hr-positive-her2-negative-advanced-breast-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/update-shows-long-term-survival-benefit-with-abemaciclib-plus-fulvestrant-in-hr-positive-her2-negative-advanced-breast-cancer\/","title":{"rendered":"Update Shows Long-Term Survival Benefit with Abemaciclib Plus Fulvestrant in HR-positive, HER2-negative Advanced Breast Cancer"},"content":{"rendered":"

The subgroup of East Asian women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer and disease progression on endocrine therapy participating in the phase III MONARCH 2 study continued to show improved survival outcomes compared to placebo plus fulvestrant at approximately 4-year follow-up, according to findings presented at the ESMO Asia Virtual Congress 2020<\/a>, held from 20 to 22 November 2020.<\/strong><\/p>\n

According to Chiun-Sheng Huang of the National Taiwan University Hospital in Taipei, Taiwan the global, double-blind, randomised phase III MONARCH 2 (NCT02107703) study demonstrated that abemaciclib\/fulvestrant had a manageble safety profile and the combination significantly improved median progression-free survival (PFS) to 16.4 months versus 9.3 months with placebo\/fulvestrant (hazard ratio [HR] 0.553; p < 0.001) and prolonged median overall survival (OS) to 46.7 versus 37.3 months, respectively (HR 0.757; p = 0.01), providing an OS benefit of 9.4 months in patients with HR-positive, HER2-negative advanced breast cancer who progressed on endocrine therapy.<\/p>\n

Furthermore, previously reported findings from the study showed that data from the subgroup of patients enrolled from Japan, Korea, Taiwan were consistent with the intent-to-treat (ITT) population and with patients from other regions; median PFS in this subgroup was 21.2 months with abemaciclib\/fulvestrant compared to11.6 months with placebo\/fulvestrant (HR 0.520; p < 0.001).<\/p>\n

MONARCH 2 enrolled 669 patients with HR-positive, HER2-negative advanced breast cancer and progression on endocrine therapy. Eligible patients included pre- or perimenopausal on ovarian suppression and postmenopausal who were randomised 2:1 to receive continuous abemaciclib at 150 mg every 12 hours or placebo; both treatment arms also were treated with fulvestrant at 500 mg per label. Exploratory subgroup analyses were done on East Asian patients in the ITT population.<\/p>\n

At ESMO Asia Virtual Congress 2020, Professor Huang presented OS and other updated efficacy findings at 4-year follow-up, as well as safety data for the East Asian subgroup in the MONARCH 2 study.<\/p>\n

Updated findings all favoured abemaciclib plus fulvestrant over placebo plus fulvestrant<\/h4>\n

The ITT population contained 212 East Asian patients of whom 147 were treated with abemaciclib plus fulvestrant and 65 received placebo plus fulvestrant; at data cut-off on 20 June 2019, 89 OS events had occurred in these patients.<\/p>\n

At this time, median OS was not reached (NR) for abemaciclib\/fulvestrant compared to 48.9 months with placebo\/fulvestrant (HR 0.798; 95% confidence interval [CI] 0.515-1.235; p = 0.38). The 42 month OS rates were 64% (95% CI 55.5-71.8) with abemaciclib\/fulvestrant compared to 53% (95% CI 39.9-64.6) with placebo\/fulvestrant.<\/p>\n

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Overall survival in ITT and East Asian population in the MONARCH 2 study.<\/p>\n

\u00a9 Chiun-Sheng Huang.<\/p>\n<\/div>\n<\/figcaption><\/figure>\n<\/div>\n<\/div>\n

In addition, significantly improved outcomes favouring abemaciclib\/fulvestrant over placebo\/fulvestrant were observed for  time-to-second-objective-disease-progression (PFS2) (HR 0.588; 95% CI 0.420-0.823; p = 0.001), time to chemotherapy (HR 0.601; 95% CI 0.411-0.877; p = 0.008), and chemotherapy-free survival (HR 0.573; 95% CI; 0.402-0.815; p = 0.002).<\/p>\n

The safety profile in the East Asian patients was consistent with previously reported safety data and no new safety signals were reported.<\/p>\n

Conclusions<\/h4>\n

The authors noted that findings from this update were consistent with previous reports in the ITT and East Asian populations. In the long-term, abemaciclib plus fulvestrant was an effective and tolerable treatment for East Asian patients with HR-positive, HER2-negative advanced breast cancer who progressed on endocrine therapy.<\/p>\n

Funding was reported from Eli Lilly and Company.<\/p>\n

Reference<\/h4>\n

45O \u2013 Huang C-S, Toi M, Im Y-H, et al.<\/em> Abemaciclib plus fulvestrant in East Asian women with HR+, HER2- advanced breast cancer: Overall Survival from MONARCH 2. ESMO Asia Virtual Congress 2020<\/a> (20 to 22 November).<\/p>\n

Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The subgroup of East Asian women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer and disease progression on endocrine therapy participating in the phase III MONARCH 2 study continued to show improved survival outcomes compared to placebo plus fulvestrant at approximately 4-year follow-up, according to findings presented at the ESMO Asia Virtual Congress 2020, held […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-26585","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26585","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=26585"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26585\/revisions"}],"predecessor-version":[{"id":44078,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26585\/revisions\/44078"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=26585"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=26585"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=26585"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}