ISPY2 results for cemiplimab (anti PD-1) plus fianlimab (anti LAG-3):
pCR rates vs control of 44% (95% CI, 34%-53%) vs 21% (95% CI, 17%-25%) in all ERBB2, 53% (95% CI, 39%-67%) vs 29% (95% CI, 22%-36%) in triple-negative, and 36% (95% CI, 23%-49%) vs 14% (95% CI, 9%-19%) in HR-positive and ERBB2-negative disease. Among the total participants, 16 (21%) experienced adrenal insufficiency, including hypophysitis (11% grade 3 or 4), mostly occurring after immunotherapy completion.
the addition of cemiplimab and fianlimab to standard NCT resulted in impressive pCR rates in all subsets of patients with early-stage high-risk ERBB2-negative breast cancer, most notably in those with the immune-positive signature status. However, this combination was associated with concerning rates of irAEs, including adrenal insufficiency and late development of diabetes.
https://pubmed.ncbi.nlm.nih.gov/42530945/
pCR rates vs control of 44% (95% CI, 34%-53%) vs 21% (95% CI, 17%-25%) in all ERBB2, 53% (95% CI, 39%-67%) vs 29% (95% CI, 22%-36%) in triple-negative, and 36% (95% CI, 23%-49%) vs 14% (95% CI, 9%-19%) in HR-positive and ERBB2-negative disease. Among the total participants, 16 (21%) experienced adrenal insufficiency, including hypophysitis (11% grade 3 or 4), mostly occurring after immunotherapy completion.
the addition of cemiplimab and fianlimab to standard NCT resulted in impressive pCR rates in all subsets of patients with early-stage high-risk ERBB2-negative breast cancer, most notably in those with the immune-positive signature status. However, this combination was associated with concerning rates of irAEs, including adrenal insufficiency and late development of diabetes.
https://pubmed.ncbi.nlm.nih.gov/42530945/
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