A regulatory endpoint for drugs that block spread, not tumours
Today a cancer drug is approved for shrinking tumours. A drug that stopped cancer spreading would fail that test, so almost nobody develops one. A new endpoint would fix that.
Anti-metastatic agents act on dissemination, seeding and outgrowth, not on the size of existing lesions, so they look inactive by RECIST and are killed in phase 2. A qualified endpoint family — new-lesion-free survival, number of new anatomical sites over time, and site-specific metastasis-free survival — would let sponsors run trials that can succeed. Regulators already accept metastasis-free survival in non-metastatic prostate cancer, which is the precedent to generalise.
- Metastasis is understood least and studied last · Metastasis causes about nine in ten cancer deaths but gets a small fraction of research money and almost no trials of its own.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
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