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Bavarian Nordic – Ineffective Cancer Vaccine Masked By Misleading Data: Kerrisdale

Is Bavarian Nordic Dendreon 2.0? Ineffective Cancer Vaccine Masked By Misleading Data by Sahm Adrangi, Kerrisdale Capital

Bavarian Nordic is a $1.3B Danish vaccine-maker whose stock price has recently surged (up 63% YTD) thanks to excitement over its putative prostate cancer treatment, Prostvac-VF, a therapeutic vaccine currently undergoing a Phase III clinical trial. Bavarian Nordic touts its earlier Phase II study of Prostvac as showing the “most pronounced survival to date in prostate cancer,” with an 8.5-month improvement in median overall survival, handily outperforming blockbuster drugs like Zytiga and Xtandi. The announcement in March that Bristol-Myers Squibb was paying $60mm upfront for an exclusive option to license and commercialize the vaccine gave investors great confidence that, despite the uncertainty surrounding any clinical trial, Prostvac is likely to succeed.

This confidence is misplaced. The often cited 8.5-month improvement is an illusion: treatment-arm survival was unexceptional relative to the results of other trials in similar patient populations, while placebo-arm survival was anomalously poor. This strikingly bad placebo performance likely had several causes, but one important one was age: relative to men who received Prostvac, those who received a placebo were much older – indeed, older than any group we have come across in any prostate-cancer clinical trial. Researchers have clearly and consistently found – as common sense would suggest – that elderly men with prostate cancer, compared to their younger counterparts, do in fact live substantially less long. Comparing an unexceptional treatment group to an anomalously bad placebo group is a good way to show a strong benefit where none truly exists.

More recent efforts to demonstrate improved survival in patients receiving both Prostvac and the cancer drug Yervoy only further underscore Prostvac’s inefficacy. In a 30-patient trial with no control group...