Tag Archives: IDMC

December, 2018

6 December
AbbVie Halts Enrollment of Phase 3 Trial Evaluating Rova-T as Second-Line Therapy for Advanced Small-Cell Lung Cancer

NORTH CHICAGO, Ill., Dec. 5, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee (IDMC) recommended stopping …
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16 August
CEL-SCI Reports Recent Data Review by the IDMC for Its Pivotal Phase 3 Head and Neck Cancer Study

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) announced today that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data. The data from all 928 enrolled …
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12 June
Lilly and AstraZeneca Discontinue Late-Stage Trials of Lanabecestat for the Treatment of Alzheimer’s Disease

INDIANAPOLIS, June 12, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and AstraZeneca are discontinuing the global Phase 3 clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor, for the treatment of Alzheimer’s disease. The decision is based on recommendations by an independent data monitoring committee …
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10 August
Lilly’s Breast Cancer Combo Treatment Fails to Meet Goals in its Late-Stage Study

INDIANAPOLIS, Aug. 10, 2016 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) provided the recommendation to continue the study without modification as the interim efficacy criteria were not met. The MONARCH 2, Phase 3 …
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1 April
Genmab Announces Positive Interim Results in Phase III Multiple Myeloma Study

Copenhagen, Denmark; March 30, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Phase III Castor study (MMY3004) of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint of improving progression free survival (PFS) …
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25 November
Genmab Halts Late-Stage Lymphoma Trial

Copenhagen, Denmark; November 23, 2015 – Genmab A/S (OMX: GEN) announced today that the Phase III study of single agent ofatumumab compared to single agent rituximab in patients with follicular non-Hodgkin’s lymphoma (NHL) that has relapsed at least 6 months after completion of treatment with a rituximab-containing regimen will be stopped …
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