Avid Bioservices Inc (CDMO)

[biopharm]

PPHM-BAVITUXIMAB-SUNRISE in total perspective

Introduction

On Thirsday, during after-hours, PPHM stopped the SUNRISE clinical trial based on a futility advice of the IDMC (Independent Data Monitoring Commission). There are many reasons for futility. For instance it could be that the drug under investigation doesn't work or works poorly compared to the goals set in the trial design.

In the case of SUNRISE there was no problem with the drug under investigation, Bavituximab, but an anomaly in the Control arm – the people that get SOC Docetaxel+Placebo – showing that those people lived much longer then what was expected in the SUNRISE trial design. And hence, if the IDMC sees that the control arm outperforms it will at a certain point conclude that compared with the GOALS set for the Bavi arm patients to outlive the control arm by two months (SOC+2) becomes impossible or unlikely. Hence the advice to stop the trial for futility.

So futility is a GENERAL term, which is seldom even used in the IDMC letters, to say to a sponsor (PPHM): There is little or no chance that if you run this clinical trial to the end you will reach the end-points. You should stop the trial. And that is what PPHM did.
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Now, has anyone else requested the list of all IDMC members on Sunrise ? Even some that were once possibly on the IDMC and then were not or pulled off for any reason or all involved in knowing the data that was in hand

Very interesting Merckly times we live here

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Summary

DMCs should be utilized for all randomized trials, especially trials that utilize important clinical endpoints such as survival or cancer progression. The safety of the patients and integrity of the trial are the primary focal points during interim data collection. Access to confidential data must be carefully managed by experienced and non-conflicted IDMC members whose expertise spans both clinical and statistical issues. Guidance for sponsors on these issues has been established by respected agencies, including the FDA.
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4516383/#__ffn_sectitle