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Who Wins the Race for Summit's Ivonescimab?
- Oncofocus Team
- Jul 7
- 2 min read
⭐ Summit Therapeutics, Inc. has reportedly been in partnership discussions with AstraZeneca and other major pharma companies for its sole asset, Ivonescimab (PD-1xVEGF BsAb) (Ref 1).
⭐ The potential deal, which could be valued at a staggering ~$15 billion (or higher?), would give a significant return on investment for Summit, which acquired the rights to ivonescimab from Akeso Biopharma in Dec 2022 in a transaction worth up to $5 billion, with a $500 million upfront payment (Ref 2).
⭐ If finalized, the partner would gain access to the promising BsAb that demonstrated superiority over Merck & Co/MSD's blockbuster drug Keytruda (pembrolizumab) in multiple pivotal trials conducted in China (Ref 3).
⭐ However, in the global HARMONi trial, though ivonescimab demonstrated a significant PFS benefit (a primary endpoint), it failed to achieve significant OS benefit (another primary endpoint) vs platinum-doublet chemo in EGFR+ve, LA/M non-squamous NSCLC (Ref 4).
⭐ Additionally, the US FDA feedback creates regulatory hurdle, as the agency specified that "a statistically significant OS benefit is necessary to support marketing authorization". Nevertheless, Summit intends to file the BLA and will consider the timing of the filing based on the discussions with the FDA (Ref 4).
⭐ Besides the HARMONi trial, ivonescimab is also being studied in two additional, Global Phase 3 trials in NSCLC (Ref 5).
⭐ Moreover, as a part of ivonescimab's broader development plan, Summit has also established clinical collaborations to evaluate ivonescimab with Pfizer's ADCs and Revolution Medicines' RAS(ON) Inhibitors (Ref 6, 7).
⭐ Overall, the success of ivonescimab triggered a significant interest in the PD-(L)1/VEGF bispecific space, with major companies like Bristol Myers Squibb, MSD, and Pfizer making substantial investments in similar BsAbs.
⭐ BMS entered $11 billion partnership with BioNTech SE for BNT327 (PD-L1xVEGF-A BsAb, originally developed by Biotheus, a China-based company acquired by BioNTech in 2024), MSD paid $588 million upfront ($2.7 billion in milestone payments) for LaNova Medicines' LM-299 (PD-1xVEGF BsAb), and Pfizer spent $1.25 billion upfront (~$4.8 billion in milestone payments) on 3SBio Inc.'s SSGJ-707 (PD-1xVEGF BsAb) (Ref 8, 9, 10, 11).
⭐ Some of the other major pharma players are also trying to catch up in the field through partnerships. It will be interesting to see whether AstraZeneca or another company ultimately partners with Summit for ivonescimab.
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