Clinical Trials (Phase III)
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Eli Lilly’s ANNOUNCE Phase III clinical trial of Lartruvo (olaratumab) in advanced or metastatic soft tissue sarcoma failed to meet the primary endpoints of overall survival.
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Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of LARTRUVO®
1/18/2019
Study did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population.
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AgeneBio Announces First Patient Enrollment in the Phase 3 Clinical Trial to Evaluate AGB101 to Treat Amnestic Mild Cognitive Impairment Due to Alzheimer's Disease
1/17/2019
- AGB101 is the first investigational therapeutic that targets the reduction of hippocampal overactivity. - The study evaluates both Primary and Secondary Endpoints to measure cognitive and functional efficacy. - Secondary imaging endpoints will include measures of neurodegeneration.
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Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) as First-line Treatment for Patients with Advanced Gastric Cancer
1/17/2019
Innovent Biologics, Inc. announced that the first patient has been dosed in a phase III clinical trial (ORIENT-16) that is to evaluate Tyvyt®, in combination with capecitabine and oxaliplatin, as first-line treatment for patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ).
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Taiho Oncology and Servier Present Data on LONSURF® (trifluridine/tipiracil) at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI)
1/17/2019
Taiho Oncology, Inc. and Servier announced that the safety and efficacy in patients with gastrectomy from the global Phase 3 TAGS trial evaluating LONSURF® in patients with previously treated metastatic gastric cancer (mGC) are consistent with the overall study results published in The Lancet Oncology.
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Acorda Announces The Lancet Neurology Publication of Phase 3 Data for INBRIJA™ (levodopa inhalation powder)
1/17/2019
SPAN℠-PD, the efficacy and safety study of INBRIJA (CVT-301), showed significant improvement in motor function during OFF periods in people with Parkinson’s on a carbidopa/levodopa regimen
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Aradigm Announces Detailed Third Party Evaluation Results for Apulmiq (FDA)/Linhaliq (EMA)
1/16/2019
Aradigm Corporation announced specific, detailed results of an independent third party evaluation (TPE) of the Phase 3 clinical trial results for Apulmiq.
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Merck’s Keytruda just keeps on proving its value to the company and patients. The company released data from KEYNOTE-181, a Phase III trial of Keytruda as a monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma.
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Your Feedback Matters! Topics in 2019
1/15/2019
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Let us know which topics you want to hear more about. -
Eisai to Present Results of Post-Hoc Analyses of Lenvima (Lenvatinib) Phase III Reflect Study in Hepatocellular Carcinoma at 2019 Gastrointestinal Cancers Symposium
1/15/2019
Eisai Co., Ltd. announced today that presentations on a series of abstracts highlighting the latest data from post-hoc analyses of a Phase III clinical study (REFLECT/Study 304) on its in-house discovered multiple receptor tyrosine kinase inhibitor lenvatinib mesylate will be presented during the 2019 Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco from January 17 to 19.
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European Commission Approves Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) for First-Line Treatment of Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma
1/14/2019
Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Commission has approved the combination of Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (“low-dose”) for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
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Daiichi Sankyo Initiates Pivotal Phase 3 Trial of [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Low Metastatic Breast Cancer
1/14/2019
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the first patient has been dosed in DESTINY-Breast04, a global pivotal phase 3 study evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan (DS-8201),
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Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma
1/14/2019
Approval based on statistically significant and clinically meaningful overall survival benefit demonstrated in the CELESTIAL phase 3 pivotal trial
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Post-Hoc Analyses from Pivotal Phase 3 REFLECT Trial of LENVIMA® (lenvatinib) in Unresectable Hepatocellular Carcinoma to be Presented at 2019 Gastrointestinal Cancers Symposium
1/14/2019
Eisai Inc. announced the presentation of four abstracts at the 2019 Gastrointestinal Cancers Symposium (#GI19), taking place in San Francisco from January 17-19, 2019
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Merck’s KEYTRUDA® (pembrolizumab) Reduced Risk of Death by 31 Percent Compared to Chemotherapy in Previously Treated Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Expressed PD-L1 (CPS ≥10)
1/14/2019
Results from Phase 3 KEYNOTE-181 Trial to be Presented at 2019 Gastrointestinal Cancers Symposium (ASCO GI)
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Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic Colorectal Cancer
1/14/2019
Data will be presented at ASCO 2019 Gastrointestinal Cancers Symposium
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For a moment, simply contemplate the possible price: $2.1 million for a drug. It’s not just any drug, however. Cambridge, Mass.-based bluebird bio’s LentiGlobin is a gene therapy being evaluated for transfusion-dependent ß-thalassemia.
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New England Journal of Medicine publishes positive results of the pivotal trial of Cablivi® (caplacizumab) for rare blood clotting disorder
1/9/2019
HERCULES Phase 3 trial met its primary endpoint, demonstrating that treatment with Cablivi resulted in a significantly faster time to platelet count response in patients with acquired thrombotic thrombocytopenic purpura (aTTP) when administered in conjunction with plasma exchange and immunosuppression
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Seattle Genetics Announces Publication of North American Subgroup Data from ECHELON-1 Phase 3 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Newly Diagnosed Advanced Hodgkin Lymphoma
1/9/2019
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the publication of data from the ECHELON-1 phase 3 clinical trial online in the journal Clinical Cancer Research.
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Biotech and pharma companies came roaring out of the gate on the first day of the annual J.P. Morgan Healthcare Conference with big deals, expansions and promises of growth and pipeline sustainability.