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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.
Shares Trial design, endpoints and cost, HR-positive / HER2-negative breast cancer, Prostate cancer.
Shares Metastasis is understood least and studied last, HR-positive / HER2-negative breast cancer, Prostate cancer.
Shares RECIST, Oligometastatic disease.
Shares Oligometastatic disease, Metastasis is understood least and studied last.
Shares Overall survival (OS), Trial design, endpoints and cost.
Shares Oligometastatic disease, Metastasis is understood least and studied last, HR-positive / HER2-negative breast cancer, Prostate cancer.
Shares Overall survival (OS), Trial design, endpoints and cost.
Shares Overall survival (OS), Trial design, endpoints and cost.