Tissue-Agnostic Approach To Cancer Drug Development Takes A Hit
Roche's VE-BASKET trial based treatment on biomarkers instead of the tissue of origin, but it ended up reinforcing the importance of conventional tumor histology in drug development as a complement to new molecularly targeted approaches. Now, eyes are on Novartis' ambitious SIGNATURE program to confirm the signal-finding potential of the basket trial approach.
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Agency officials and oncologists debate considerations where a data package overwhelms non-responders in favor of a tissue-agnostic indication.
But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic cancer therapies are not always equally effective.
Basket trials are building a path for tissue-agnostic drug development in oncology, and plans are proceeding for more master protocols in pediatric cancers, acute myeloid leukemia and pancreatic cancer.