Thread by @AdeAdamson

New @JAMADerm cost-effectiveness study on use of combination Talmogene Laherparepvec (Tvec) + ipilimumab (ipi) vs ipi alone. Cost of 1 year of life w/o tumor growth was $2.2 million!!! Blistering editorial by Zeke Emanuel and @sarah_dimagno thread👇🏾
jamanetwork.com/journals/jamad…

This cost effectiveness analysis was based on a 2018 Phase II study of stage III/IV unresectable melanoma patients randomized to ipi alone or ipi + Tvec
here: ncbi.nlm.nih.gov/pmc/articles/P…

In case you were wondering how to pronounce it: Tal-i-mo-gene La-herp-arep-vec. Thankfully there is a video showing you how to say it on youtube!
here:

Tvec is a genetically modified herpes virus that expresses GM-CSF. Tvec increases tumor specific immune activation so the idea is that it has complementary action with ipi, hence the trial.

Tvec is a medication injected directly into melanoma lesions. Its supposed to work by revving up the immune system to attack melanoma elsewhere in the body.

In the trial the primary endpoint was objective response rate (ORR). Pause! 🤔

This is a quickly lethal and devastating condition, why on earth isn’t OS the primary endpoint?

The study showed ORR benefit of 39% in ipi+Tvec vs 18% in ipi alone. There was NO PFS or OS benefit!!!

In a cost effectiveness analysis using this trial data, Almutairi and colleagues not only show that cost was >$2 million for 1 year of PFS but also $1.6 million for 1 additional patient to get ORR!!!

How can a drug combo at this price ever be justified, especially without even a PFS benefit not to mention no OS benefit?

I interviewed corresponding author Dr. Ivo Abraham about this study on the @JAMADerm podcast. Have a listen to our discussion:
edhub.ama-assn.org/jn-learning/au…

Also, check out the biting editorial about the implications of this paper and cancer drug costs in general from Zeke Emanuel and co-author @sarah_dimagno
link: jamanetwork.com/journals/jamad…