The Trial is OVER! Data Is Imminent
On 4/23/20, CVM released the major news!!!
At the most recent IDMC meeting in April 2020 the IDMC reviewed progression free and overall survival and limited demographic and safety data available for the aforementioned protocol. The IDMC made the following recommendation:
There is a nice write up about the IDMC news on SeekingAlpha: HERE
Press Release from October stating the trial should continue on!
You read that right. Interim analysis is done to DETERMINE FUTILITY.
It would have been deemed futile if Multikine wasn't extending survival over standard care by 10% or more!
The IDMC's job is to check the study to assess safety, sample size and futility. This is laid out on the CT Site.
From the CT Site it says:
Primary Outcome Measures
1. Overall Survival (OS) in LI + CIZ + SOC vs. SOC
OS will be assessed using Kaplan-Meier life-table and compared using a logrank test and confirmed further with tumor stage location and geographic stratified log rank tests. The unstratified logrank test constitutes the primary analysis. A two-sided p-value of 0.05 or less will be considered statistically significant for comparing the two groups. Interim analyses will be performed throughout the study to assess safety, sample size and futility.
In April 2020, the IDMC reviewed the trial for Safety, sample size (ie drop outs) and Possibly Futility. ALL PASSED! It was safe, enrolled enough and with ~99% of the data, hadn't been determined to be futile if this was tested.
They SHUT 'EM DOWN all the time.
On March 13, 2020, the IDMC recommended to shut down the Javelin Head & Neck Cancer study for FUTILITY!
"The IDMC found at an interim analysis that the combo wasn’t likely to significantly extend the time to tumor progression or death versus standard-of-care chemoradiotherapy alone. "
The IDMC recommended that the “JAVELIN” study, which hasn’t treated patients in years, be shut down for FUTILITY. The drug failed to meet its endpoint.
They haven’t treated patients in years, but the IDMC didn’t recommend that the trial continue. Instead, they recommended to stop it.
Why has the IDMC recommended that the Multikine trial continue to the endpoint rather than recommending to end it for Futility? Aren’t they done dosing patients too? Isn’t that the key?
Dosing patients means nothing. It’s about the IDMC seeing if the drug will meet its endpoint.
On April 12, 2019 the IDMC recommended to shut down TWO TRIALS!!!
Tracon Pharmaceuticals trial
"Tracon Pharmaceuticals Inc. shares TCON, -49.24% slid 45% in premarket trade Friday, after the company said it is terminating a late-stage trial of a cancer treatment at the recommendation of an independent committee. The company said its phase 3 trial evaluating TRC105 in combination with Votrient in patients with advanced or metastatic angiosarcoma, a rare kind of cancer, was terminated for futility based on the recommendation of the Independent Data Monitoring Committee following a review of data from more than 120 patients. "
"Clovis Oncology Inc said on Friday it was halting a mid-stage trial testing its lead drug in bladder cancer patients, sending shares down 12 percent.
The company said its decision to discontinue the trial was based on recommendations of an independent committee, which suggested that the treatment may not provide a meaningful benefit to patients."
On March 22, 2019 The IDMC shut down BIOGEN's Alzheimer's Study
"Biogen BIIB and its Japan-based partner Eisai announced the discontinuation of two late-stage studies evaluating their Alzheimer’s disease candidate, aducanumab. The decision was taken following a futility analysis conducted by an independent data monitoring committee (“IDMC”). The analysis showed that the studies are unlikely to meet their primary endpoints."
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