# Summit Therapeutics

Canonical page: https://technooptimist.io/companies/summit-therapeutics
Summit develops ivonescimab, a two-in-one antibody licensed from China's Akeso, in its territories (the US, Canada, Europe, Japan, Latin America, the Middle East and Africa). Its first US filing faces an FDA decision in November 2026.

## In brief

- Licensed ivonescimab from Akeso in Dec 2022: $500M upfront, up to ~$4.56B in milestones, low double-digit royalties.
- FDA decision on the first US filing (EGFR-mutant lung cancer) due 14 Nov 2026; FDA says survival benefit is key.
- Head-to-head lung trial vs Keytruda (HARMONi-3, ~1,600 patients) fully enrolled; first readout expected H2 2026.

## Facts

- Headquarters: US
- Status: public
- Website: https://www.smmttx.com
- Frontiers: [Biotech](https://technooptimist.io/biotech.md) (Antibody drugs)

## Programs

- [Ivonescimab](https://technooptimist.io/biotech/ivonescimab.md) (Biotech): Pilot; next: HARMONi-3 squamous cohort: progression-free survival readout (2026). Approved in China; FDA decision for EGFR-mutant lung cancer due 14 Nov 2026; Keytruda head-to-head running.

## Technical approach

- **Two targets: PD-1 and VEGF in one molecule**: One antibody releases the immune brake PD-1 and starves tumours of VEGF, the signal that grows new blood vessels.
- **Cooperative binding: Binds harder inside tumours**: In lab tests VEGF raises its grip on PD-1 several-fold, so it should act most where both are abundant: inside the tumour.
- **Strategy: Global trials after China wins**: Akeso's China-only trials beat Keytruda; Summit runs multiregional phase 3s to seek US and European approval.

## Open problems

- **Survival, not just slower growth** (open): In HARMONi, survival gain missed significance (HR 0.79, p=0.057); FDA says it needs a significant survival benefit.
- **Do China results carry over?** (active research): HARMONi-2 and HARMONi-6 ran only in China; the global HARMONi-3 must show the same edge over Keytruda.

## Upcoming

- **14 Nov 2026**: FDA decision on ivonescimab + chemo in EGFR-mutant lung cancer (Ivonescimab)
- **2027**: HARMONi-3 non-squamous progression-free survival readout (H1 2027) (Ivonescimab)

## Latest updates

- **15 Sep 2026**: HARMONi-2 survival data: ivonescimab cuts risk of death by 27% versus Keytruda. At the 2026 World Conference on Lung Cancer, investigators reported that ivonescimab alone extended overall survival compared with Keytruda alone in PD-L1-positive advanced lung cancer in the China HARMONi-2 trial. ([our story](https://technooptimist.io/stories/harmoni-2-survival-data-ivonescimab-cuts-risk-of-death-by-27-versus-936c243d.md) · [original source](https://ascopost.com/news/september-2026/ivonescimab-significantly-improves-overall-survival-vs-pembrolizumab-in-pd-l1-positive-advanced-nsclc/))
- **31 May 2026**: HARMONi-6: ivonescimab plus chemo extends survival over tislelizumab plus chemo in squamous lung cancer. Akeso's China phase 3 HARMONi-6 showed that ivonescimab plus platinum chemotherapy lengthened survival compared with the PD-1 antibody tislelizumab plus chemotherapy as first treatment for squamous lung cancer. ([our story](https://technooptimist.io/stories/harmoni-6-ivonescimab-plus-chemo-extends-survival-over-tislelizumab-55af2e13.md) · [original source](https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000043/ivonescimab-withxchemoth.htm))
- **Jan 2026**: FDA accepts Summit's first ivonescimab filing; decision due 14 Nov 2026, with survival flagged as the key question. The FDA accepted Summit's application for ivonescimab plus chemotherapy in EGFR-mutant non-squamous lung cancer after targeted-pill (TKI) therapy, setting a 14 November 2026 decision date. ([our story](https://technooptimist.io/stories/fda-accepts-summit-s-first-ivonescimab-filing-decision-due-14-nov-2026-66e6270c.md) · [original source](https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000068/smmt-20260630.htm))
- **8 Sep 2024**: Ivonescimab beats Keytruda in HARMONi-2, nearly doubling progression-free survival in lung cancer. Akeso's phase 3 HARMONi-2 trial in China compared ivonescimab head-to-head with Keytruda (pembrolizumab) as first treatment for PD-L1-positive advanced lung cancer. ([our story](https://technooptimist.io/stories/ivonescimab-beats-keytruda-in-harmoni-2-nearly-doubling-progression-7d56fc52.md) · [original source](https://ascopost.com/issues/november-25-2024-supplement-conference-highlights-2024-wclc/harmoni-2-ivonescimab-outperforms-pembrolizumab-as-first-line-treatment-in-nsclc/))

## Partners, customers and investors

- Akeso (partner): Discovered ivonescimab (AK112); licensed it to Summit in Dec 2022 and runs the China trials.

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