Summit Therapeutics and Akeso celebrate third China approval for ivonescimab as new data show waning survival benefit
Summit Therapeutics and its partner Akeso received a third approval in China for ivonescimab, a PD-1/VEGF bispecific antibody, for first-line treatment of advanced squamous non-small cell lung cancer.
The National Medical Products Administration granted the approval for ivonescimab in combination with chemotherapy.
The agency also released a label update that includes Phase 3 HARMONi-6 data indicating that progression-free survival declines over time, dampening expectations for the drug.
Analysts at Leerink Partners said the new information increases pessimism, warning that the ongoing HARMONi-3 trial may not demonstrate a substantial benefit needed for U.S. FDA accelerated approval.
This writeup was produced by pharmadog from original reporting by BioSpace.
Original headline: “Summit, Akeso’s China approval celebration cut short as survival benefit degrades”
read at BioSpace ↗
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