{"id":7329,"date":"2016-02-23T12:24:29","date_gmt":"2016-02-23T20:24:29","guid":{"rendered":"https:\/\/www.sfj-pharma.com\/?p=7329"},"modified":"2021-05-13T14:32:06","modified_gmt":"2021-05-13T22:32:06","slug":"inotuzumab-ozogamicin-ino-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy","status":"publish","type":"post","link":"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/","title":{"rendered":"Inotuzumab ozogamicin (InO) for relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL) in the phase III INO-VATE trial: Efficacy and safety by prior therapy"},"content":{"rendered":"\r\n<p><strong>Background:<\/strong>InO, an anti-CD22 antibody-calicheamicin conjugate, showed superior response vs standard care for R\/R ALL in the phase III INO-VATE trial. Herein, effects of prior therapy on response and toxicities were assessed in patients (pts) receiving InO.\u00a0<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p><strong>Methods:<\/strong>Per protocol, intent-to-treat analyses of complete remission [CR]\/CR with incomplete hematologic recovery [CRi] included the first 218 of 326 pts randomized (ITT218). The safety population included 139 pts who received \u2265 1 InO dose (max 1.8 mg\/m<sup>2<\/sup>\/cycle [0.8 mg\/m<sup>2<\/sup>\u00a0on d1; 0.5 mg\/m<sup>2<\/sup>\u00a0on d8 and 15 of a 21\u201328 d cycle for \u2264 6 cycles]). Minimal residual disease (MRD) negativity was assessed by central flow cytometry ( &lt; 0.01%). Data as of October 2, 2014 are presented (trial ongoing).\u00a0<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p><strong>Results:<\/strong>109 pts in the ITT218 received InO (CR\/CRi rate, 81% [95% CI, 72\u201388]; MRD negativity rate in responders, 78% [95% CI, 68\u201387]; median remission duration [DoR], 4.6 [95% CI, 3.9\u20135.4] mo). 67% and 32% of pts received InO as salvage (S) 1 and S2 (missing, n = 1). For S1 vs S2, response was numerically higher, MRD-negativity was similar, and DoR was numerically longer (Table). CR\/CRi rate was numerically lower for pts with (n = 17) vs without (w\/o) (n = 92) prior SCT (77% [95% CI, 50\u201393] vs 82% [72\u201389]). In the safety population, Gr \u2265 3 febrile neutropenia rates were similar for S1 (n = 95) vs S2 (n = 43) (both 23%) and for pts with (n = 24) vs w\/o (n = 115) prior SCT (29% vs 23%). Any grade hepatobiliary AE rates were significantly higher in S2 vs S1 (47% vs 17%;\u00a0<em>P<\/em>&lt; 0.001) and numerically higher for pts with vs w\/o prior SCT (42% vs 23%). For S1 vs S2, 36 vs 11 pts had poststudy SCT. Veno-occlusive liver disease (VOD) including post-SCT VOD occurred in 8% of S1 vs 16% of S2 pts (2 fatal in S1); in 21% with vs 9% w\/o prior SCT (1 fatal in each cohort).\u00a0<\/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 may provide clinical benefit in pts with R\/R ALL for both S1 and S2 therapy; hepatotoxicity risk increases with number of prior therapies and prior SCT. 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><a href=\"https:\/\/meetinglibrary.asco.org\/record\/123994\/abstract\" target=\"_blank\" rel=\"noreferrer noopener\">Read full article on ASCO Meeting Library.<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Background:InO, an anti-CD22 antibody-calicheamicin conjugate, showed superior response vs standard care for R\/R ALL in the phase III INO-VATE trial. Herein, effects of prior therapy on response and toxicities were assessed in patients (pts) receiving InO.\u00a0 &nbsp; Methods:Per protocol, intent-to-treat analyses of complete remission [CR]\/CR&#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 v22.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Inotuzumab ozogamicin (InO) for relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL) in the phase III INO-VATE trial: Efficacy and safety by prior therapy - 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-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Inotuzumab ozogamicin (InO) for relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL) in the phase III INO-VATE trial: Efficacy and safety by prior therapy - SFJ Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"Background:InO, an anti-CD22 antibody-calicheamicin conjugate, showed superior response vs standard care for R\/R ALL in the phase III INO-VATE trial. Herein, effects of prior therapy on response and toxicities were assessed in patients (pts) receiving InO.\u00a0 &nbsp; Methods:Per protocol, intent-to-treat analyses of complete remission [CR]\/CR...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/\" \/>\n<meta property=\"og:site_name\" content=\"SFJ Pharmaceuticals\" \/>\n<meta property=\"article:published_time\" content=\"2016-02-23T20:24:29+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-05-13T22:32:06+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=\"2 minutes\" \/>\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-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/\"},\"author\":{\"name\":\"Lily Xu\",\"@id\":\"https:\/\/www.sfj-pharma.com\/#\/schema\/person\/770e5cbce35f5f0f90d2218806ceba11\"},\"headline\":\"Inotuzumab ozogamicin (InO) for relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL) in the phase III INO-VATE trial: Efficacy and safety by prior therapy\",\"datePublished\":\"2016-02-23T20:24:29+00:00\",\"dateModified\":\"2021-05-13T22:32:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/\"},\"wordCount\":341,\"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-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/\",\"url\":\"https:\/\/www.sfj-pharma.com\/inotuzumab-ozogamicin-ino-for-relapsed-refractory-r-r-acute-lymphoblastic-leukemia-all-in-the-phase-iii-ino-vate-trial-efficacy-and-safety-by-prior-therapy\/\",\"name\":\"Inotuzumab ozogamicin (InO) for relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL) in the phase III INO-VATE trial: Efficacy and safety by prior therapy - 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