TheTechno Optimist.

IvonescimabSummit Therapeutics—HARMONi-6: ivonescimab plus chemo extends survival over tislelizumab plus chemo in squamous lung cancerIvonescimabSummit Therapeutics—HARMONi-2 survival data: ivonescimab cuts risk of death by 27% versus KeytrudaIvonescimabSummit Therapeutics—FDA accepts Summit's first ivonescimab filing; decision due 14 Nov 2026, with survival flagged as the key question

Ivonescimab

by Summit TherapeuticsUS

Replace PD-1 antibodies like Keytruda as the backbone of cancer immunotherapy by adding blood-vessel blockade in the same molecule, first in lung cancer, where most patients still die within a few years.

PilotStage 3 of 5

Approved in China; FDA decision for EGFR-mutant lung cancer due 14 Nov 2026; Keytruda head-to-head running.

Updated 26d agoChecked 11 Oct0 updates this week

Milestones

Next · HARMONi-3 squamous cohort: progression-free survival readout
  1. Summit licenses ivonescimab from AkesoDec 2022Complete.
  2. First approval, by China's NMPAMay 2024Complete.
  3. HARMONi-2 (China): beats Keytruda on progression-free survivalSep 2024Complete.
  4. HARMONi-6 (China): survival gain vs tislelizumab, ASCO plenaryMay 2026Complete.
  5. FDA accepts first US filing (EGFR-mutant lung cancer)Jan 2026Complete.
  6. HARMONi-3 squamous cohort: progression-free survival readoutTarget 2026Current milestone.
  7. FDA decision (PDUFA)Target 14 Nov 2026Not yet reached.
  8. HARMONi-3 non-squamous cohort: progression-free survival readoutTarget 2027Not yet reached.

Most important updates

Upcoming

  1. 2026HARMONi-3 squamous cohort: progression-free survival readout (next)
  2. 14 Nov 2026FDA decision (PDUFA)
  3. 2027HARMONi-3 non-squamous cohort: progression-free survival readout
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