Akeso lung cancer drug cuts death risk by 34% in landmark trial

Akeso’s Ivonescimab Cuts Lung Cancer Death Risk by 34% in Landmark Trial

An experimental lung cancer drug developed by China’s Akeso reduced the risk of death by 34% compared to an established immunotherapy in a late-stage clinical trial, results announced at the American Society of Clinical Oncology annual meeting showed on Saturday.

Ivonescimab, a first-in-class bispecific antibody that targets both PD-1 and VEGF, achieved a median overall survival of 27.9 months when combined with chemotherapy, versus 23.7 months for tislelizumab (marketed as Tevimbra by BeOne Medicines, formerly BeiGene) plus chemotherapy in the Phase III HARMONi-6 trial. The hazard ratio was 0.66, with a p-value of 0.0017, meeting the threshold for statistical significance.reuters

A Win Across Subgroups

The 532-patient study enrolled patients with previously untreated advanced squamous non-small cell lung cancer at sites across China. The survival benefit was consistent regardless of PD-L1 expression status, with similar hazard ratios in patients whose tumors expressed high, low, or no PD-L1. Patients with three or more metastatic sites saw an even more pronounced benefit, with a 53% reduction in the risk of death.prnewswire

The 24-month overall survival rate was 64.7% for patients receiving ivonescimab plus chemotherapy compared to 48.6% in the control arm. The trial had previously demonstrated a progression-free survival advantage, with median PFS of 11.1 months versus 6.9 months, results published in The Lancet last year.morningstar

Global Ambitions and a Keytruda Challenge

Summit Therapeutics, which holds global rights to ivonescimab outside China, is pursuing U.S. approval through multiple pathways. The FDA accepted a Biologics License Application for ivonescimab in EGFR-mutated NSCLC with a target decision date of November 14, 2026. A separate global trial, HARMONi-3, is comparing ivonescimab directly against Merck’s blockbuster Keytruda — the world’s top-selling cancer drug — with data expected later this year.cnbc

The HARMONi-6 results mark the latest in a series of trial wins for ivonescimab since September 2024, when the drug nearly halved the risk of disease progression compared to Keytruda in the HARMONi-2 study. However, an interim analysis from HARMONi-3’s squamous cohort earlier this year failed to reach its progression-free survival endpoint, sending Summit shares lower and raising questions about whether the drug’s success in Chinese trials would translate globally.oncologypipeline

Akeso described ivonescimab as a potential new standard of care for first-line squamous NSCLC, according to Reuters. How the global HARMONi-3 overall survival data compare will likely determine the drug’s commercial trajectory in the United States and Europe.reuters