PROGNYX

Home/The Watchtower/Ivonescimab

Drug file · From the Watchtower

Ivonescimab: the briefings and the record

Every Prognyx briefing on ivonescimab, newest first, and the dated events drawn from the sources those briefings cite. Rebuilt with each new briefing.

Also known as
SMT112, AK112
Target, as briefed
PD-1 x VEGF bispecific antibody; PD-1/VEGF (bispecific)
Companies named
AstraZeneca, Summit Therapeutics, Akeso
Prognyx coverage
4 briefings, 23 July 2026 to 2 October 2026

Prognyx briefings on ivonescimab

  1. multiple tumour typesAstraZeneca and Daiichi Sankyo to evaluate Datroway with Summit's ivonescimab

    AstraZeneca and Daiichi Sankyo will evaluate their Trop-2 ADC Datroway in combination with Summit Therapeutics' ivonescimab across multiple tumour types.

  2. AstraZeneca takes $2B Summit stake, pairs its Claudin 18.2 ADC with ivonescimab

    AstraZeneca pairs its Claudin 18.2 ADC sonesitatug vedotin with Summit's PD-1/VEGF bispecific ivonescimab in GI cancers, buying into overall-survival wins over pembrolizumab and durvalumab.

  3. lung cancerSummit files HARMONi-2 OS-positive update for ivonescimab

    Summit’s 3 September 2026 8-K says Akeso reported statistically significant OS improvement for ivonescimab monotherapy versus pembrolizumab monotherapy in China’s HARMONi-2 Phase III trial in PD-L1-positive advanced NSCLC.

  4. EGFR-mutant non-small cell lung cancerIvonescimab's Western OS hazard ratio falls to 0.76, Summit hasn't yet disclosed the number the FDA said it requires

    Summit's July 22 HARMONi update shows the Western overall-survival HR converging on the ITT 0.76 as follow-up doubles, but with no median, CI or p-value disclosed, the FDA's statistical-significance requirement stays unresolved before the Nov 14 PDUFA.

Sourced timeline

Readouts, regulatory actions, filings, trial starts and deals that the Prognyx engine extracted from the documents cited in these briefings, newest first. Each links to its source and to the briefing that cited it. Press coverage is left out, and so is any event dated on its own briefing's day: the briefing above is the record for that day. A month without a day is a date the source gave only to the month.

  1. ReadoutHARMONi-2 OS update: ivonescimab beats pembrolizumab (HR 0.73)SEC 8-K (Summit Therapeutics EX-99.1, 2026-09-14) · cited in AstraZeneca takes $2B Summit stake, pairs its Claudin 18.2 ADC…
  2. Trial startEMBOLD PanTumour-103 (NCT07602855) started; recruitingClinicalTrials.gov · cited in AstraZeneca takes $2B Summit stake, pairs its Claudin 18.2 ADC…
  3. ReadoutHARMONi-GI: ivonescimab regimen significant OS superiority vs durvalumab regimenSEC 8-K (Summit Therapeutics EX-99.1, 2026-08-26) · cited in AstraZeneca takes $2B Summit stake, pairs its Claudin 18.2 ADC…
  4. Trial startSummit initiates global Phase II/III HARMONi-GU1SEC 8-K exhibit / company press release · cited in Summit files HARMONi-2 OS-positive update for ivonescimab
  5. Trial startNCT07619339 started: tepotinib + ivonescimab in METex14 NSCLCClinicalTrials.gov · cited in AstraZeneca takes $2B Summit stake, pairs its Claudin 18.2 ADC…
  6. FilingFDA accepts ivonescimab application for filing; PDUFA Nov 14 2026SEC 8-K (Summit Therapeutics EX-99.1) · cited in AstraZeneca takes $2B Summit stake, pairs its Claudin 18.2 ADC…
  7. Trial startHARMONi-7 (NCT06767514) started; recruitingClinicalTrials.gov · cited in AstraZeneca takes $2B Summit stake, pairs its Claudin 18.2 ADC…

Registered trials on file

ClinicalTrials.gov records that the cited sources tie to ivonescimab, each opening on the registry.

Want this on your pipeline?
Get a free sample competitive brief on one of your assets, sourced, sharp, no strings.
Request a sample brief → Or read how Prognyx runs continuous oncology competitive intelligence.

Prognyx briefings are built from public information and reflect Prognyx's analysis. They are not investment advice and do not promote any product or off-label use. Event titles are written by the Prognyx engine from the linked source; the source is the record.