Trial updates are coming in quite fast now, as companies seeing positive results want to bring that information to the public as soon as possible. Many are scheduled to appear at the ASH Conference on December 6th. MEI Pharma just updated investors on their AML phase 2 trial using Pracinostat (an HDACi) in combination with Vidaza for elderly newly diagnosed patients...
Below is a running total of updates the company has provided to help us understand as time goes by, which direction the trial has taken with the percentage of (CR) or complete remissions achieved.
Below is a running total of updates the company has provided to help us understand as time goes by, which direction the trial has taken with the percentage of (CR) or complete remissions achieved.
November 7th, 2014
N = 14
CR = 57%
August 1, 2014
N = 14
CR = 21%
CR + CRi = 57%
June 10, 2014
N = 9
CR = 22%
CR + CRi = 33%
From the timeline above, and the most up to date data from November 7th, out of 14 patients, 8 have achieved a complete remission, or 57%. In other words, as time goes by, we are seeing improved rates of remission in the phase 2 trial. Patients are tolerating the drug well to get the benefits of a complete remission, as 57% in this trial have. Remember that the trial is Pracinostat in combination with Vidaza. Celgene has run similar elderly patient trials in AML using Vidaza as stand alone treatment, with complete remissions of around 20%. So one has to confer, that based on these interim results, that by adding Pracinostat (an HDAC inhibitor) to Vidaza is having a positive effect for this patient population. Pracinostat is generally safe, as it has been used in up to 300 patients with different indications.
The ultimate test of success for this group of patients is OS (overall survival). There is some correlation between Complete Remissions (CR) and overall survival, but the correlation is dependent on whether the patient has abnormal cytogenetics (ACR) at first diagnosis and first day of documented Complete Remission (CR), or has normal cytogenetics (NCR) at time of first day documented CR. ACR patients had significantly shorter OS and higher rates of cumulative incidence of relapse (CIR). The relative risk of death or relapse was 2.1 times higher for ACR patients than for NCR patients according to study ncbi.nlm.nih.gov/pubmed/15197203 . The next update for this trial will have up to 30 patients and will be presented December 6th, at the ASH (American Society of Hematology) conference. Thank you for reading.
The ultimate test of success for this group of patients is OS (overall survival). There is some correlation between Complete Remissions (CR) and overall survival, but the correlation is dependent on whether the patient has abnormal cytogenetics (ACR) at first diagnosis and first day of documented Complete Remission (CR), or has normal cytogenetics (NCR) at time of first day documented CR. ACR patients had significantly shorter OS and higher rates of cumulative incidence of relapse (CIR). The relative risk of death or relapse was 2.1 times higher for ACR patients than for NCR patients according to study ncbi.nlm.nih.gov/pubmed/15197203 . The next update for this trial will have up to 30 patients and will be presented December 6th, at the ASH (American Society of Hematology) conference. Thank you for reading.
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