Summit Therapeutics’ Phase III Ivonescimab Trials Expand as FDA Accepts Chemotherapy BLA
Summit Therapeutics is conducting Phase III trials of ivonescimab in non-small cell lung and colorectal cancers; the FDA has accepted a BLA for chemotherapy combination. It ended Q4 2025 with $713.4m cash, $412.3m short-term investments and posted a net loss of $347.2m ($0.46/share) in 2025, versus $179.3m ($0.24/share) in 2024.
1. Phase III Clinical Development
Summit Therapeutics is advancing ivonescimab through Phase III trials in non-small cell lung and colorectal cancers, engaging GORTEC to open European head and neck oncology sites and planning monotherapy and combination arms with ligufalimab, while partnering with GSK to evaluate combinations with B7-H3 and risvutatug rezetecan in solid tumors.
2. FDA BLA Acceptance
The FDA has accepted Summit’s Biologics License Application for ivonescimab in combination with chemotherapy, marking a key regulatory milestone toward potential approval and commercialization in oncology markets.
3. Financial Results and Position
At the end of Q4 2025, Summit Therapeutics held $713.4 million in cash and $412.3 million in short-term investments, while reporting a widened full-year net loss of $347.2 million ($0.46/share) compared to $179.3 million ($0.24/share) in the prior year.