Exelixis plans an NDA submission for zanzalintinib after presenting mature overall‑survival data from the Phase 3 STELLAR‑303 trial showing a survival benefit when the TKI was combined with atezolizumab versus standard care. Company statements and conference presentations at ESMO reported a 20% reduction in risk of death in the intent‑to‑treat population. Detailed results published in The Lancet and presented at ESMO underpin Exelixis’ intent to seek regulatory approval later this year. Management said the totality of evidence supports the combination’s clinical value, while some analysts noted the magnitude of benefit and safety profile will influence uptake. Exelixis will now prepare regulatory packages and engage with agencies; payers and oncologists will evaluate comparative effectiveness versus existing third‑line options and new combination therapies emerging from ESMO.
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