Puma's Neratinib SUMMIT Study Shows Potential & Pitfalls Of Precision Medicine
"Basket trial" design allowed Puma to identify certain cohorts for further study, but also missed in areas where neratinib was expected to work.
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Agency officials and oncologists debate considerations where a data package overwhelms non-responders in favor of a tissue-agnostic indication.
Loxo data on the RET inhibitor LOXO-292 impressed at ASCO, so much so the company is looking to talk to regulators about the results after only a single-arm Phase I trial – but it's not a silver bullet as a tissue-agnostic treatment. Data on a separate target, PI3K, underwhelmed in breast cancer. Tissue of origin remains important, though the reasons why are not entirely understood.
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.