---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-152292"
form_type: "8-K"
ticker: "SMMT"
cik: "0001599298"
company_name: "Summit Therapeutics Inc."
filed_at: "2024-06-03T23:59:59+00:00"
generated_at: "2026-06-01T06:48:50.287611+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Ivonescimab plus chemo gets NMPA approval in China for EGFRm NSCLC; PFS HR 0.46 in HARMONi-A

## Summary
- NMPA approved ivonescimab + chemo for 2L+ EGFR-mutant non-squamous NSCLC based on HARMONi-A Phase III trial sponsored by Akeso.
- PFS hazard ratio 0.46 (p<0.001); median PFS 7.1 months vs 4.8 months for placebo + chemo.
- ORR 50.6% vs 35.4% and DCR 93.1% vs 83.2%; OS trended positive (HR 0.72 at 10.2 mo follow-up).
- Subgroup with 3rd-gen TKI: PFS HR 0.48; safety manageable — 5.6% discontinued ivonescimab due to TRAEs.
- Multi-regional HARMONi trial (target 420 patients) enrolling; completion expected in H2 2024.

## SEC filing metadata
- accession: 0001193125-24-152292
- form_type: 8-K
- ticker: SMMT
- cik: 0001599298
- company_name: Summit Therapeutics Inc.
- filed_at: 2024-06-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1599298/000119312524152292/0001193125-24-152292-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1599298/000119312524152292/d38200d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-152292
- JSON: https://secwatch.observer/filing/0001193125-24-152292.json
- Plain text: https://secwatch.observer/filing/0001193125-24-152292.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.