Akeso, Summit’s PD-1xVEGF Drug Ivonescimab Shows Strong Progression-Free Survival Benefit in Global Lung Cancer Trial

Ivonescimab, a PD-1xVEGF bispecific antibody developed by Akeso and Summit, achieved a significant reduction in the risk of progression or death (by 48%) in its first global phase 3 trial (HARMONi), in patients with EGFR-mutated, nonsquamous non-small cell lung cancer (NSCLC) who had progressed after third-generation EGFR TKI therapy14.

The primary endpoint met in the trial was progression-free survival (PFS), and ivonescimab plus chemotherapy performed better than chemotherapy alone, with effects consistent across Asian and non-Asian populations14.

No new safety concerns were identified, and the safety profile was comparable to control arms in the study24.

Despite these positive PFS results, ivonescimab has not yet demonstrated a statistically significant overall survival benefit in the global trial, which may delay regulatory approval in the U.S.13.

Ivonescimab has now succeeded in multiple phase 3 lung cancer trials, showing benefit both as monotherapy and in combination with chemotherapy for various NSCLC settings24.

The drug’s novel tetravalent structure is designed for high avidity in tumor tissue, enhancing its therapeutic targeting and safety characteristics5.

Sources:

1. https://www.biopharmadive.com/news/summit-ivonescimab-pd1-vegf-egfr-lung-cancer-study-results/749401/

2. https://www.fiercepharma.com/pharma/new-trial-akesos-ivonescimab-shows-success-vs-keytruda-no-fluke

3. https://www.statnews.com/2025/05/30/summit-shows-ivonescimab-lung-cancer-mixed-results/

4. https://www.fiercepharma.com/pharma/akeso-summits-ivonescimab-delayed-progression-48-certain-lung-cancers-first-global-phase-3

5. https://www.smmttx.com/pressrelease/https-www-smmttx-com-wp-content-uploads-2025-08-2025pr0811--q2-2025-earnings-press-release--final-pdf/