vintafolide in combination with pegylated liposomal doxorubicin

Exemple de traitement s'avérant délétères

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Exemple de résultats intermédiaires non confirmés par des essais ultérieurs

1. Etudes de cas

1.1. Gemtuzumab ozogamicin

Gemtuzumab ozogamicin was approved in 2000 for the treatment of pediatric leukemia on the basis of limited data, but it was withdrawn from the market in 2010 after confirmatory trials initiated in 2004 showed increased mortality and no efficacy.42 p.1258: 42. Food and Drug Administration. Mylotarg (gemtuzumab ozogamicin): market withdrawal. Silver Spring, MD: FDA, June 21, 2010.

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1.2. vintafolide in combination with pegylated liposomal doxorubicin

WHITEHOUSE STATION, N.J. WEST LAFAYETTE, Ind., May 2, 2014 – Merck, known as MSD outside the United States and Canada (NYSE: MRK), and Endocyte, Inc. (NASDAQ: ECYT), today announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has completed a pre specified, interim futility analysis and the DSMB recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer. The DSMB did not identify any safety concerns for the patients enrolled in the trial. Based on the DSMB recommendation and while further review of the data are conducted, the Companies have taken steps to notify investigators that screening and randomization of participants in the trial will be suspended.

PROCEED is a Phase 3 randomized, double-blind clinical trial, evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive, platinum-resistant, ovarian cancer. The primary endpoint of the trial was PFS as measured by RECIST v 1.1 (Response Evaluation Criteria In Solid Tumor) criteria in patients with all target tumor lesions positive as assessed by etarfolatide imaging agent.

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2. divers notes à rédiger

[ref] en oncologie 60% d'echec en phase 3

3. Exemples d'essais de phase 3 négatifs

Astraunote (aliskiren)

Re-align (dabigatran)

echoCRT

ACCOAST (prasugrel)

Niami

Catis

Mild hypothermia

4. Exemple de traitement s'avérant délétères

Exemple de situation où c'est les patients du grp placebo qui ont eu de la chance

CAST

Torcetrapid (ILLUSTRATE ILLUMINATE)

Apixaban (ACS PRAISE)

Dronedarone dans l'insuffisance cardiaque N Engl J Med 2008;358:2678-87 [ref]

ACCORD intensification dans le diabetes

MAST

Corticosteroids increased short and long-term mortality in adults with traumatic head injury Critical Care 9: E21 (DOI: 10.1186/cc3813) [ref]

EPO 10.1056/NEJMp0912328 [ref]

Références

référence Kola:2004bq inexistante Pubmed

référence Kober, 2008 :50 inexistante Pubmed

référence Czekajlo, 2005 :49 inexistante Pubmed

référence Unger, 2010 :48 inexistante Pubmed