Biotech Values

[iwfal]

re:CAR-T lymphoma risk

Comments:

A) CABA, coincidentally, had a cc scheduled the day after that announcement and they spent most of it addressing this FDA warning. They did a fairly good job (clearly an all out prep in preceding 24 hours), including summarizing data from Big Pharma on this topic. The cc is a good summary.

B) a very high percentage of the patients who go on CART have previously had, or subsequently have, secondary cancer inducing treatments. Eg in some (many? all?) Kymriah trials 50% of patients failed a previous Allogeneic stem cell transplant (most involving large doses of radiation). And some of the standard chemo regimens themselves have warnings about secondary cancers, including T Cell.

C) many popular therapies for treating immune diseases have warning about risk of secondary cancers. Yet they sell well despite this and provide substantially less benefit that has been seen in Schett CART data for Lupus etc.

D) one of the providers of existing CART therapies has noted that they have yet to see a T-Cell cancer that was in T-cells loaded with the CAR. (This will be a key metric for CART secondary cancer risk, how many showed CAR). Out of multiple 1000s treated.

My WAG is as long as this is in neighborhood of 1/1000 or less it won’t be much of an impediment to sales. Even at 1 in 500, given the enormous benefit… . And right now VAERS says it’s around 1 in 1000 overall (potentially mostly caused by other treatments?), although undoubtedly VAERS is an undercount.