{"id":7339,"date":"2018-02-23T12:27:01","date_gmt":"2018-02-23T20:27:01","guid":{"rendered":"https:\/\/www.sfj-pharma.com\/?p=7339"},"modified":"2021-05-13T14:21:01","modified_gmt":"2021-05-13T22:21:01","slug":"inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb","status":"publish","type":"post","link":"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/","title":{"rendered":"Inotuzumab ozogamicin (InO) treatment in patients with relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL): Analysis from INO-VATE by bone marrow blast percentage (BMB%)"},"content":{"rendered":"\r\n<p><strong>Background:<\/strong>InO is a calicheamicin-conjugated antibody targeting CD22 on ALL blast cells. Here we report outcomes in R\/R ALL patients (pts) receiving InO or standard of care chemotherapy (SC) in the phase 3 INO-VATE trial according to baseline BMB%, an indicator of disease burden.<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p><strong>Methods:<\/strong>Adults with CD22+ ALL due to receive salvage treatment were randomized 1:1 to InO (n = 164) or SC (n = 162). Dosing and methods were published previously (Kantarjian et al, NEJM 2016). BMB% was defined as low ( &lt; 50%), moderate (50\u201390%), and high ( &gt; 90%) at start of treatment.<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p><strong>Results:<\/strong>At baseline, characteristics across all groups were balanced and median BMB% was 28%, 78%, and 95% in the low, moderate, and high disease burden subgroups. Complete remission rates were significantly higher in InO vs SC pts, with 74% vs 46%, 75% vs 48%, and 70% vs 17% achieving CR\/CRi in low, moderate, and high BMB% subgroups. Significantly more pts in the InO arm achieved minimal residual disease negativity: 29\/53 (55%), 52\/79 (66%), and 16\/30 (53%) for low, moderate, and high BMB% compared with 10\/48 (21%), 11\/83 (13%), and 2\/30 (7%) for SC, respectively. InO-treated pts also had improved progression-free survival vs SC, with hazard ratios of 0.44 (97.5% CI, 0.26\u20130.74, 1-sided\u00a0<em>P<\/em>= 0.0001) for low, 0.50 (97.5% CI, 0.34\u20130.75,\u00a0<em>P<\/em>&lt; 0.0001) for moderate, and 0.33 (97.5% CI, 0.16\u20130.69,\u00a0<em>P<\/em>= 0.0002) for high BMB%. Overall survival (OS) was favored in the InO arm across groups (Table) with potentially the greatest difference seen in pts with high BMB% (HR = 0.60 [97.5% CI 0.32\u20131.129, 1-sided\u00a0<em>P<\/em>= 0.03]). Clinical trial information:\u00a0<a href=\"http:\/\/clinicaltrials.gov\/show\/NCT01564784\">NCT01564784<\/a><\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p><strong>Conclusions:<\/strong>InO treatment resulted in superior efficacy over SC across all BMB% subgroups out to 2 years follow-up, particularly in patients with the greatest disease burden by BMB%.<\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/meetinglibrary.asco.org\/record\/162434\/abstract\" target=\"_blank\" rel=\"noreferrer noopener\">Read full article on ASCO Meeting Library.<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Background:InO is a calicheamicin-conjugated antibody targeting CD22 on ALL blast cells. Here we report outcomes in R\/R ALL patients (pts) receiving InO or standard of care chemotherapy (SC) in the phase 3 INO-VATE trial according to baseline BMB%, an indicator of disease burden. &nbsp; Methods:Adults&#8230;<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Inotuzumab ozogamicin (InO) treatment in patients with relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL): Analysis from INO-VATE by bone marrow blast percentage (BMB%) - SFJ Pharmaceuticals<\/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.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Inotuzumab ozogamicin (InO) treatment in patients with relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL): Analysis from INO-VATE by bone marrow blast percentage (BMB%) - SFJ Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"Background:InO is a calicheamicin-conjugated antibody targeting CD22 on ALL blast cells. Here we report outcomes in R\/R ALL patients (pts) receiving InO or standard of care chemotherapy (SC) in the phase 3 INO-VATE trial according to baseline BMB%, an indicator of disease burden. &nbsp; Methods:Adults...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/\" \/>\n<meta property=\"og:site_name\" content=\"SFJ Pharmaceuticals\" \/>\n<meta property=\"article:published_time\" content=\"2018-02-23T20:27:01+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-05-13T22:21:01+00:00\" \/>\n<meta name=\"author\" content=\"Lily Xu\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Lily Xu\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/\"},\"author\":{\"name\":\"Lily Xu\",\"@id\":\"https:\/\/www.sfj-pharma.com\/#\/schema\/person\/770e5cbce35f5f0f90d2218806ceba11\"},\"headline\":\"Inotuzumab ozogamicin (InO) treatment in patients with relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL): Analysis from INO-VATE by bone marrow blast percentage (BMB%)\",\"datePublished\":\"2018-02-23T20:27:01+00:00\",\"dateModified\":\"2021-05-13T22:21:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/\"},\"wordCount\":281,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.sfj-pharma.com\/#organization\"},\"articleSection\":[\"Scientific Publications\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/\",\"url\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-treatment-in-patients-with-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-analysis-from-ino-vate-by-bone-marrow-blast-percentage-bmb\/\",\"name\":\"Inotuzumab ozogamicin (InO) treatment in patients with relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL): Analysis from INO-VATE by bone marrow blast percentage (BMB%) - 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