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Jacobs Pediatric Cancer Fund"},{"DOI":"10.13039\/100020812","name":"Robert Steel Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100020812","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Hematol Oncol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      With high-risk neuroblastoma, post-induction metastases in bone marrow (BM)\/bones confers a poor prognosis but can respond to anti-G\n                      <jats:sub>D2<\/jats:sub>\n                      antibody, such as naxitamab. We report results of a phase I\/II trial.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Cycles included GM-CSF and naxitamab infused (30-to-90\u00a0min) on days\u2009+\u20091,\u2009+\u20093,\u2009+\u20095. Naxitamab was dose-escalated in the trial\u2019s phase I portion and administered at 9\u00a0mg\/kg\/cycle (i.e.,\u2009~\u2009270\u00a0mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      \/cycle)\u2014the recommended phase II dosage (RP2D)\u2014in the phase II expansion. Cycles were monthly\u2009\u00d7\u20095 after a major response, i.e., complete (CR) or partial response.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 32 subjects, CR was noted in 24 (75%), including 12 by international criteria and 12 based on MIBG-avid sites with negative PET scans. BM CR was achieved in 22\/23 with BM metastases. Of 29 patients with abnormal\n                      <jats:sup>123<\/jats:sup>\n                      I-MIBG scans, major responses occurred in 14\/20 with Curie scores (CS) 10\u201325 and in 7\/9 with CS 1\u20139. Of 9 patients previously treated with other anti-G\n                      <jats:sub>D2<\/jats:sub>\n                      antibodies, 5 became event-free survivors. Post-protocol, 18 patients received anti-neuroblastoma vaccine. Five-year progression-free\/overall survival rates were 38%\/64%. Baseline CS, prior 2nd-line therapy, and prior anti-G\n                      <jats:sub>D2<\/jats:sub>\n                      antibody did not significantly impact survival.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Naxitamb\u2009+\u2009GM-CSF is an attractive option for primary refractory osteomedullary disease, including in patients with a high disease burden.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trials registration<\/jats:title>\n                    <jats:p>Clinicaltrials.gov NCT01757626.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13045-025-01770-7","type":"journal-article","created":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T11:34:51Z","timestamp":1764156891000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Naxitamab plus stepped-up dosing of granulocyte\u2013macrophage colony-stimulating factor for primary refractory high-risk neuroblastoma: results of a phase I\/II trial"],"prefix":"10.1186","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8916-0697","authenticated-orcid":false,"given":"Brian H.","family":"Kushner","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shakeel","family":"Modak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Audrey","family":"Mauguen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen M.","family":"Basu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen S.","family":"Roberts","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nai-Kong V.","family":"Cheung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,26]]},"reference":[{"issue":"3","key":"1770_CR1","doi-asserted-by":"publisher","first-page":"422","DOI":"10.1016\/j.annonc.2019.11.011","volume":"31","author":"F Berthold","year":"2020","unstructured":"Berthold F, Faldum A, Ernst A, Boos J, Dilloo D, Eggert A, et al. 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Oncotarget. 2017;8(56):95293\u2013302.","journal-title":"Oncotarget"},{"issue":"21","key":"1770_CR43","doi-asserted-by":"publisher","first-page":"6441","DOI":"10.1158\/1078-0432.CCR-17-0379","volume":"23","author":"SM Federico","year":"2017","unstructured":"Federico SM, McCarville MB, Shulkin BL, Sondel PM, Hank JA, Hutson P, et al. A pilot trial of humanized anti-GD2 monoclonal antibody (hu14.18K322A) with chemotherapy and natural killer cells in children with recurrent\/refractory neuroblastoma. Clin Cancer Res. 2017;23(21):6441\u20139.","journal-title":"Clin Cancer Res"},{"key":"1770_CR44","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2022.1041443","volume":"12","author":"N Olgun","year":"2022","unstructured":"Olgun N, Cecen E, Ince D, Kizmazoglu D, Baysal B, Onal A, et al. Dinutuximab beta plus conventional chemotherapy for relapsed\/refractory high-risk neuroblastoma: a single-center experience. Front Oncol. 2022;12:1041443.","journal-title":"Front Oncol"},{"key":"1770_CR45","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2023.1082771","volume":"13","author":"A Wieczorek","year":"2023","unstructured":"Wieczorek A, Zaniewska-Tekieli A, Ehlert K, Pawinska-Wasikowska K, Balwierz W, Lode H. Dinutuximab beta combined with chemotherapy in patients with relapsed or refractory neuroblastoma. Front Oncol. 2023;13:1082771.","journal-title":"Front Oncol"},{"key":"1770_CR46","doi-asserted-by":"publisher","DOI":"10.3390\/cancers15133364","author":"HN Lode","year":"2023","unstructured":"Lode HN, Ladenstein R, Troschke-Meurer S, Struppe L, Siebert N, Zumpe M, et al. Effect and tolerance of N5 and N6 chemotherapy cycles in combination with dinutuximab beta in relapsed high-risk neuroblastoma patients who failed at least one second-line therapy. Cancers (Basel). 2023. https:\/\/doi.org\/10.3390\/cancers15133364.","journal-title":"Cancers (Basel)"},{"key":"1770_CR47","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2024.114001","volume":"202","author":"P Raiser","year":"2024","unstructured":"Raiser P, Schleiermacher G, Gambart M, Dumont B, Defachelles AS, Thebaud E, et al. Chemo-immunotherapy with dinutuximab beta in patients with relapsed\/progressive high-risk neuroblastoma: does chemotherapy backbone matter? Eur J Cancer. 2024;202:114001.","journal-title":"Eur J Cancer"}],"container-title":["Journal of Hematology &amp; Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13045-025-01770-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13045-025-01770-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13045-025-01770-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,30]],"date-time":"2025-12-30T03:02:06Z","timestamp":1767063726000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s13045-025-01770-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,26]]},"references-count":47,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["1770"],"URL":"https:\/\/doi.org\/10.1186\/s13045-025-01770-7","relation":{},"ISSN":["1756-8722"],"issn-type":[{"value":"1756-8722","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,26]]},"assertion":[{"value":"22 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 November 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 November 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This report covers all HR-NB patients enrolled on the Memorial Sloan Kettering Cancer Center (FWA00004998) protocol 12-230 (Clinicaltrials.gov NCT01757626). The study was approved and informed written consents were obtained according to MSK Institutional Review Board rules.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The authors declare the following conflicts: naxitamab has been licensed by Memorial Sloan Kettering Cancer Center (MSK) to Y-mAbs Therapeutics Inc., and MSK. SM is a co-inventor on patents related to naxitamab and omburtamab licensed by MSK to YMAbs Therapeutics. N-KVC was named as inventor on multiple patents filed by Memorial Sloan Kettering Cancer Center (MSK), including those licensed to YmAbs Therapeutics and Biotec Pharmacon\/Lallemand. MSK and N-KVC have financial interest in Y-mAbs. NKC consults for and receives stock options from Eureka Therapeutics.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"114"}}