Clinical Holds in Early Oncology Drug Development

Abstract

Clinical holds in oncology are necessary to safeguard patients. Researchers are alerted to holds by news sources, but a systematic evaluation of clinical holds in early oncology drug development is lacking. Analysis of publicly disclosed clinical holds in oncology from 2016-2021 identified 39 holds. The majority (n=29) were for toxicity-related reasons, with fewer for chemistry, manufacturing and controls (CMC) (n=7) or other reasons (n=3). Toxicity-related holds took a median of 74 days till resolution, whereas chemistry, manufacturing and controls (CMC)-related holds took a median of 108 days to resolve. Acknowledging the limited sample size and scope of stock market conditions, toxicity-related clinical holds impacted the market value of small/medium sized biotechs by a median of -15%, which is far more than large biopharma (median 0%). These data suggest that toxicity-related clinical holds are common in early oncology and can have a more detrimental impact on small/medium sized biotech sponsors, the latter of which could have substantial financial repercussions, particularly in “biotech bear markets” where public investing in the sector has fallen out of favor (as in 2021-2022).