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{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,21]],"date-time":"2024-01-21T12:20:39Z","timestamp":1705839639157},"reference-count":50,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2022,7,15]],"date-time":"2022-07-15T00:00:00Z","timestamp":1657843200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher"},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher"},{"DOI":"10.13039\/501100002670","name":"ABB","doi-asserted-by":"publisher"},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher"},{"DOI":"10.13039\/501100002883","name":"Clough","doi-asserted-by":"publisher"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,2,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n <jats:sec>\n <jats:title>Background<\/jats:title>\n <jats:p>Approximately 50% of newly diagnosed glioblastomas (GBMs) harbor epidermal growth factor receptor gene amplification (EGFR-amp). Preclinical and early-phase clinical data suggested efficacy of depatuxizumab mafodotin (depatux-m), an antibody\u2013drug conjugate comprised of a monoclonal antibody that binds activated EGFR (overexpressed wild-type and EGFRvIII-mutant) linked to a microtubule-inhibitor toxin in EGFR-amp GBMs.<\/jats:p>\n <\/jats:sec>\n <jats:sec>\n <jats:title>Methods<\/jats:title>\n <jats:p>In this phase III trial, adults with centrally confirmed, EGFR-amp newly diagnosed GBM were randomized 1:1 to radiotherapy, temozolomide, and depatux-m\/placebo. Corneal epitheliopathy was treated with a combination of protocol-specified prophylactic and supportive measures. There was 85% power to detect a hazard ratio (HR) \u22640.75 for overall survival (OS) at a 2.5% 1-sided significance level (ie traditional two-sided p \u2264 0.05) by log-rank testing.<\/jats:p>\n <\/jats:sec>\n <jats:sec>\n <jats:title>Results<\/jats:title>\n <jats:p>There were 639 randomized patients (median age 60, range 22\u201384; 62% men). Prespecified interim analysis found no improvement in OS for depatux-m over placebo (median 18.9 vs. 18.7 months, HR 1.02, 95% CI 0.82\u20131.26, 1-sided p = 0.63). Progression-free survival was longer for depatux-m than placebo (median 8.0 vs. 6.3 months; HR 0.84, 95% confidence interval [CI] 0.70\u20131.01, p = 0.029), particularly among those with EGFRvIII-mutant (median 8.3 vs. 5.9 months, HR 0.72, 95% CI 0.56\u20130.93, 1-sided p = 0.002) or MGMT unmethylated (HR 0.77, 95% CI 0.61\u20130.97; 1-sided p = 0.012) tumors but without an OS improvement. Corneal epitheliopathy occurred in 94% of depatux-m-treated patients (61% grade 3\u20134), causing 12% to discontinue.<\/jats:p>\n <\/jats:sec>\n <jats:sec>\n <jats:title>Conclusions<\/jats:title>\n <jats:p>Interim analysis demonstrated no OS benefit for depatux-m in treating EGFR-amp newly diagnosed GBM. No new important safety risks were identified.<\/jats:p>\n <\/jats:sec>","DOI":"10.1093\/neuonc\/noac173","type":"journal-article","created":{"date-parts":[[2022,7,18]],"date-time":"2022-07-18T14:13:54Z","timestamp":1658153634000},"page":"339-350","source":"Crossref","is-referenced-by-count":26,"title":["Depatuxizumab mafodotin in EGFR-amplified newly diagnosed glioblastoma: A phase III randomized clinical trial"],"prefix":"10.1093","volume":"25","author":[{"ORCID":"http:\/\/orcid.org\/0000-0001-7386-9928","authenticated-orcid":false,"given":"Andrew B","family":"Lassman","sequence":"first","affiliation":[{"name":"Division of Neuro-Oncology, Department of Neurology, Columbia University Vagelos College of Physicians and Surgeons and New York-Presbyterian Hospital, New York , New York , USA"},{"name":"Herbert Irving Comprehensive Cancer Center, New York , New York , USA"}]},{"given":"Stephanie L","family":"Pugh","sequence":"additional","affiliation":[{"name":"RTOG Foundation Statistics 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E","family":"Bain","sequence":"additional","affiliation":[{"name":"Abbvie, Inc. , North Chicago, Illinois , USA"}]},{"given":"Vincent","family":"Blot","sequence":"additional","affiliation":[{"name":"Abbvie, Inc. , North Chicago, Illinois , USA"}]},{"given":"Peter J","family":"Ansell","sequence":"additional","affiliation":[{"name":"Abbvie, Inc. , North Chicago, Illinois , USA"}]},{"given":"Suvajit","family":"Samanta","sequence":"additional","affiliation":[{"name":"Abbvie, Inc. , North Chicago, Illinois , USA"}]},{"ORCID":"http:\/\/orcid.org\/0000-0001-6616-5762","authenticated-orcid":false,"given":"Madan G","family":"Kundu","sequence":"additional","affiliation":[{"name":"Abbvie, Inc. , North Chicago, Illinois , USA"}]},{"given":"Terri S","family":"Armstrong","sequence":"additional","affiliation":[{"name":"Neuro-Oncology Branch, National Cancer Institute , Bethesda, MD , USA"}]},{"given":"Jeffrey S","family":"Wefel","sequence":"additional","affiliation":[{"name":"Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center , Houston, Texas , USA"}]},{"given":"Clemens","family":"Seidel","sequence":"additional","affiliation":[{"name":"University Hospital Leipzig , Leipzig , Germany"}]},{"given":"Filip Y","family":"de Vos","sequence":"additional","affiliation":[{"name":"University Medical Center Utrecht, Cancer Center , Utrecht , The Netherlands"}]},{"given":"Sigmund","family":"Hsu","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Texas Health Sciences Center , McGovern School of Medicine, Houston, Texas , USA"}]},{"given":"Andr\u00e9s F","family":"Cardona","sequence":"additional","affiliation":[{"name":"Foundation for Clinical and Applied Cancer Research-FICMAC\/Clinical and Translational Oncology Group, Brain Tumor Section , Bogot\u00e1 , 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