{"id":27170,"date":"2021-06-17T17:30:00","date_gmt":"2021-06-17T17:30:00","guid":{"rendered":"http:\/\/72c1caf8432bcea5d1051a960d390bf3"},"modified":"2024-11-03T15:14:52","modified_gmt":"2024-11-03T15:14:52","slug":"adding-checkpoint-inhibition-to-anti-her2-breast-cancer-therapy-brings-no-benefit-esmo-virtual-plenary-press-release","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/adding-checkpoint-inhibition-to-anti-her2-breast-cancer-therapy-brings-no-benefit-esmo-virtual-plenary-press-release\/","title":{"rendered":"Adding Checkpoint Inhibition to Anti-HER2 Breast Cancer Therapy Brings no Benefit [ESMO Virtual Plenary Press Release]"},"content":{"rendered":"<p>VP6-2021 &#8211; IMpassion050: A phase III study of neoadjuvant atezolizumab + pertuzumab + trastuzumab + chemotherapy (neoadj A + PH + CT) in high-risk, HER2-positive early breast cancer (EBC)<\/p>\n<div id=\"question-idm45653001572496\" readability=\"283\">\n<p><u>J. Huober<\/u><sup>1<\/sup>, C.H. Barrios<sup>2<\/sup>, N. Niikura<sup>3<\/sup>, M. Jarzab<sup>4<\/sup>, Y-C. Chang<sup>5<\/sup>, S.L. Huggins-Puhalla<sup>6<\/sup>, V. Graupner<sup>7<\/sup>, D. Eiger<sup>7<\/sup>, V. Henschel<sup>8<\/sup>, N. Gochitashvili<sup>9<\/sup>, C. Lambertini<sup>10<\/sup>, E. Restuccia<sup>7<\/sup>, H. Zhang<sup>11<\/sup><br \/><sup>1<\/sup>Cantonal Hospital, Breast Center St. Gallen, St. Gallen, Switzerland,&nbsp;<sup>2<\/sup>Centro de Pesquisa em Oncologia, Hospital S\u00e3o Lucas, PUCRS, Porto Alegre, Brazil,&nbsp;<sup>3<\/sup>Department of Breast Oncology, Tokai University School of Medicine, Tokai, Japan,&nbsp;<sup>4<\/sup>Breast Cancer Unit, Maria Sk\u0142odowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland,&nbsp;<sup>5<\/sup>Department of Surgery, Mackay Memorial Hospital, Taipei, Taiwan,&nbsp;<sup>6<\/sup>Magee-Women\u2019s Hospital, University of Pittsburgh, Pittsburgh, PA, USA,&nbsp;<sup>7<\/sup>Product Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland,&nbsp;<sup>8<\/sup>Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland,&nbsp;<sup>9<\/sup>Product Development Safety, Roche Products Limited, Welwyn Garden City, UK,&nbsp;<sup>10<\/sup>Oncology Biomarker Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland,&nbsp;<sup>11<\/sup>Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA<\/p>\n<p><strong>Background:&nbsp;<\/strong>PH + CT is standard of care for high-risk, HER2-positive EBC. PH activates antibody-dependent cellular cytotoxicity; combining A + PH + CT may restore anti-cancer immunity and further enhance activity. IMpassion050 (NCT03726879), a double-blind, randomised, placebo (PL)-controlled study, evaluated efficacy and safety of neoadj A\/PL + PH + CT. We report the primary analysis.<\/p>\n<p><strong>Methods:&nbsp;<\/strong>Patients (pts) had T2\u20134, N1\u20133, M0 disease. HER2-positivity, PD-L1 and hormone receptor (HR) status were assessed centrally. Stratification factors: T stage, HR and PD-L1 status. Randomisation was 1:1 to A\/PL 840 mg q2w Cycles (C) 1\u20134\/1200 mg q3w C5\u20138 + dose-dense doxorubicin + cyclophosphamide (ddAC) q2w C1\u20134 followed by paclitaxel (Pac) qw C5\u20138 + standard PH q3w C5\u20138. Post-surgery, pts continued PH + A\/PL to complete 52 weeks in total. Pts with residual disease could switch to trastuzumab emtansine + A\/PL. Co-primary endpoints: Pathological complete response (pCR; ypT0\/is ypN0) in the ITT and PD-L1-positive populations. Safety was a secondary endpoint. On 26\/01\/21 the IDMC met and recommended that A\/PL treatment (Tx) be stopped due to an unfavourable benefit\u2013risk profile. Data were analysed early (clinical cutoff: 05\/02\/21), with 3 pts yet to undergo surgery.<\/p>\n<p><strong>Results:&nbsp;<\/strong>226 pts were assigned to A; 228 to PL. pCR in the ITT population of the A and PL arms: 62.4% (95% CI 55.7, 68.7) and 62.7% (56.1, 69.0), respectively (\u0394 \u20130.33%; \u20139.2, 8.6;&nbsp;<em>P<\/em>&nbsp;= 1.0). pCR in the PD-L1-positive population (109 per arm): 64.2% (54.5, 73.2) and 72.5% (63.1, 80.6), respectively (\u0394 \u20138.26%; \u201320.6, 4.0;&nbsp;<em>P<\/em>&nbsp;= 0.2). In the neoadj phase, Grade 3\/4 adverse events (AEs; 51.8% v 43.6%) and serious AEs (19.5% v 13.3%) were increased with A without increased withdrawals from any study Tx. There were 4 Grade 5 AEs in the neoadj phase (alveolitis,* septic shock,* sepsis, COVID-19 [*Tx-related, per investigator]) and 1 in the adjuvant phase (COVID-19); all with A and confounded by comorbidities and concurrent events.<\/p>\n<p><strong>Conclusions:&nbsp;<\/strong>A + ddAC-PacPH did not result in increased pCR in the ITT or PD-L1-positive populations. Overall, the safety profile was consistent with the known profile in other combination studies with A, with no new safety signals.<\/p>\n<p><strong>Clinical trial identification:&nbsp;<\/strong>NCT03726879 (BO40747), 1 Nov 2018<\/p>\n<p><strong>Editorial acknowledgement:&nbsp;<\/strong>Support for third-party writing assistance for this abstract, furnished by Daniel Clyde, PhD, of Health Interactions, was provided by F. Hoffmann-La Roche Ltd<\/p>\n<p><strong>Legal entity responsible for the study:&nbsp;<\/strong>F. Hoffmann-La Roche Ltd, Basel, Switzerland<\/p>\n<p><strong>Funding:&nbsp;<\/strong>F. Hoffmann-La Roche Ltd, Basel, Switzerland<\/p>\n<p><strong>Disclosure:&nbsp;<\/strong>J. Huober: Financial Interests, Personal, Invited Speaker, Honoraria: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Celgene; Eisai, AbbVie; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd; Financial Interests, Institutional, Research Grant, Study funding: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Advisory Board: Lilly, Novartis, Roche, Pfizer, Hexal, AstraZeneca, MSD, Celgene, AbbVie; Financial Interests, Institutional, Research Grant: Celgene, Novartis, Hexal; Financial Interests, Personal, Other, Travel expenses: Roche, Pfizer, Novartis, Celgene, Daiichi.<br \/>C.H. Barrios: Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd; Financial Interests, Institutional, Research Grant, Study funding: F. Hoffmann-La Roche Ltd.<br \/>N. Niikura: Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, Eisai, Chugai, Daiichi Sankyo; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd; Financial Interests, Institutional, Research Grant, Study funding: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Advisory Board: Roche, Pfizer, AstraZeneca, MSD, Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Chugai, Daiichi-Sankyo, Pfizer, Eisai.<br \/>M. Jarzab: Financial Interests, Personal, Invited Speaker: F. Hoffmann-La Roche Ltd; Pfizer; Novartis, MSDr; Non-Financial Interests, Personal, Research Grant, Third-party writing support : F. Hoffmann-La Roche Ltd; Financial Interests, Institutional, Research Grant, Study funding: F. Hoffmann-La Roche Ltd.<br \/>Y. Chang: Financial Interests, Institutional, Research Grant, Study funding: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd.<br \/>S.L. Huggins-Puhalla: Financial Interests, Institutional, Research Grant, Study funding: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd; Financial Interests, Institutional, Research Grant: Pfizer, AstraZeneca; Non-Financial Interests, Personal, Other, Consultant\/Steering Committee membership: AbbVie, Roche.<br \/>V. Graupner: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Stocks\/Shares: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd.<br \/>D. Eiger: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Stocks\/Shares: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Research Grant, ESMO Fellowship 2018\u20132019: Novartis.<br \/>V. Henschel: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Stocks\/Shares: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd.<br \/>N. Gochitashvili: Financial Interests, Personal, Full or part-time Employment: Roche Products Limited; Financial Interests, Personal, Stocks\/Shares: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd.<br \/>C. Lambertini: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd.<br \/>E. Restuccia: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Stocks\/Shares: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd.<br \/>H. Zhang: Financial Interests, Institutional, Research Grant, Study funding: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Third-party writing support: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Other, Consultant on clinical trials: Roche\/Genentech.<\/p>\n<\/div>\n<p><a href=\"http:\/\/www.esmo.org\/newsroom\/press-office\/adding-checkpoint-inhibition-to-anti-her2-breast-cancer-therapy-brings-no-benefit\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>VP6-2021 &#8211; IMpassion050: A phase III study of neoadjuvant atezolizumab + pertuzumab + trastuzumab + chemotherapy (neoadj A + PH + CT) in high-risk, HER2-positive early breast cancer (EBC) J. Huober1, C.H. Barrios2, N. Niikura3, M. Jarzab4, Y-C. Chang5, S.L. Huggins-Puhalla6, V. Graupner7, D. Eiger7, V. Henschel8, N. Gochitashvili9, C. Lambertini10, E. Restuccia7, H. Zhang111Cantonal [&hellip;]<\/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-27170","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27170","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=27170"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27170\/revisions"}],"predecessor-version":[{"id":43750,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27170\/revisions\/43750"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=27170"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=27170"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=27170"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}