Akeso, Summit’s PD-1/VEGF bispecific records another pivotal study win in NSCLC
Title
Ivonescimab (PD-1/VEGF Bispecific) Achieves Pivotal Success in NSCLC, Challenging Standards Set by Keytruda
Keywords
- Ivonescimab
- PD-1/VEGF bispecific antibody
- Akeso
- Summit Therapeutics
- Non-small cell lung cancer (NSCLC)
- Keytruda (pembrolizumab)
- HARMONi-6 trial
- Progression-free survival (PFS)
- Cancer immunotherapy
- Chemotherapy combination
- Innovative cancer therapy
Key Facts
- Ivonescimab is a novel, first-in-class PD-1/VEGF bispecific antibody developed by Akeso and Summit Therapeutics, representing a new generation of immunotherapy for solid tumors235.
- In the pivotal phase 3 HARMONi-6 trial for advanced squamous non-small cell lung cancer (NSCLC), ivonescimab combined with chemotherapy demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to BeiGene’s Tevimbra (tislelizumab) plus chemotherapy5.
- Previous studies have also shown ivonescimab outperforming Merck's Keytruda (pembrolizumab) in delaying tumor progression or death for NSCLC, with positive results across both PD-L1-positive and PD-L1-negative patients15.
- Ivonescimab leverages Akeso’s proprietary Tetrabody technology, giving it four antigen-binding sites for enhanced binding specificity to both PD-1 and VEGF targets—potentially leading to greater efficacy and a stable safety profile1.
- The safety profile of ivonescimab plus chemotherapy showed no new safety signals, with serious adverse events and grade 3+ bleeding rates comparable to control arms5.
- Although VEGF-related side effects (notably proteinuria and hypertension) were higher with ivonescimab versus Keytruda, none led to discontinuation or were above grade 3 severity1.
- Akeso and Summit Therapeutics have initiated collaborations with Pfizer to explore ivonescimab in combination with Pfizer’s antibody-drug conjugates (ADCs), aiming to broaden the therapeutic landscape for solid tumors beyond NSCLC2.
- Experts highlight that, if these benefits are consistently confirmed, ivonescimab could redefine the first-line treatment landscape in NSCLC and pose a substantial challenge to existing standards like Keytruda145.
Sources:
1. https://www.fiercepharma.com/pharma/akeso-summit-pd-1-bispecific-crushes-merck-keytruda-new-standard-lung-cancer
2. https://www.prnewswire.com/news-releases/akeso-highlights-collaboration-between-its-partner-summit-therapeutics-and-pfizer-to-explore-ivonescimab-in-combination-with-pfizers-adcs-302383996.html
3. https://www.smmttx.com/ivonescimab-smt112/
4. https://www.biospace.com/drug-development/summits-bispecific-beats-yet-another-cancer-med-pressuring-keytrudas-supremacy
5. https://www.fiercepharma.com/pharma/new-trial-akesos-ivonescimab-shows-success-vs-keytruda-no-fluke