# Summit Therapeutics

Source: https://onco.cc/companies/summit-therapeutics/  
OnCo record `summit-therapeutics` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Summit Therapeutics holds Western rights to ivonescimab and is running the global HARMONi trials.

## Summary

Summit Therapeutics, based in Miami and listed as SMMT, holds the Western rights to ivonescimab, Akeso's PD-1 by VEGF bispecific antibody, and is running the global HARMONi trials. HARMONi-3 tests it in first-line non-small-cell lung cancer and HARMONi-7 in PD-L1-high disease, both phase 3. The FDA accepted Summit's first biologics licence application in January 2026, for ivonescimab with chemotherapy in EGFR-mutated non-squamous non-small-cell lung cancer after a tyrosine kinase inhibitor, with a decision date of 14 November 2026; the application rests on the overall results of the HARMONi trial. In September 2026 AstraZeneca agreed to invest 2.0 billion dollars in Summit through convertible preferred stock, and Summit's partner Akeso reported an overall survival benefit for ivonescimab over pembrolizumab in HARMONi-2. OnCo links it to non-small-cell lung cancer and cutaneous squamous cell carcinoma, to HARMONi-A, and to the HARMONi-2 paper in which ivonescimab beat pembrolizumab head to head. Whether a Chinese head-to-head win can be reproduced in a Western population, and whether the FDA will accept it, is the open question the company exists to answer. Ivonescimab has its own page.

## Fields

- Kind: Company
- Last checked: 2026-10-29
- HQ: Miami, FL
- Type: biotech
- Website: https://www.smmttx.com
- Ticker: SMMT

## Notes

- Freshened 29 October 2026 from Summit's SEC filings. No acquisition of Summit was found. The FDA decision due 14 November 2026 had not been announced at the time of writing.

## Sources

- Official website: https://www.smmttx.com
- FDA accepts ivonescimab BLA (SEC 8-K, January 2026): https://www.sec.gov/Archives/edgar/data/1599298/000159929826000006/smmt-20260129.htm
- AstraZeneca investment (SEC 8-K, September 2026): https://www.sec.gov/Archives/edgar/data/1599298/000119312526405776/d178892d8k.htm
- HARMONi-2 overall survival (SEC 8-K, September 2026): https://www.sec.gov/Archives/edgar/data/1599298/000159929826000076/smmt-20260902.htm

## Connected records

- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- drugs: [Ivonescimab](https://onco.cc/drugs/ivonescimab/)
- trials: [A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07535437/), [A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma](https://onco.cc/trials/nct07815665/), [A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07535463/), [Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1](https://onco.cc/trials/nct06767514/), [HARMONi-3](https://onco.cc/trials/harmoni-3/), [HARMONi-A](https://onco.cc/trials/harmoni-a/), [Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC](https://onco.cc/trials/nct07405190/), [Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer](https://onco.cc/trials/nct06959550/), [Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer](https://onco.cc/trials/nct07057791/), [Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets](https://onco.cc/trials/nct07234877/), [Phase III Study of AK112 for NSCLC Patients](https://onco.cc/trials/nct06396065/), [Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer](https://onco.cc/trials/nct07228832/), [Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases](https://onco.cc/trials/nct07359456/)
- cancers: [Cutaneous squamous cell carcinoma](https://onco.cc/cancers/cutaneous-scc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/)
- key papers: [HARMONi-2: ivonescimab, a PD-1 x VEGF bispecific, beats pembrolizumab head-to-head in PD-L1-positive lung cancer](https://onco.cc/key-papers/paper-harmoni-2-lancet-2025/)

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