Summit Therapeutics has released more Phase III trial data for ivonescimab in non-small cell lung cancer (NSCLC) as it awaits a decision from US regulators.
The global Phase III HARMONi trial (NCT06396065) investigated the novel, potential first-in-class investigational bispecific antibody plus platinum-doublet chemotherapy compared to placebo plus chemotherapy in patients with endothelial growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI).
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In the new data, the study demonstrated a statistically significant benefit in the primary analysis for progression-free survival (PFS), one of the study’s two primary endpoints along with overall survival (OS).
The data, with a cut-off of June 2026, showed that OS following treatment with the Akeso-partnered drug and chemotherapy had a hazard ratio in the Western subgroup of 165 patients of 0.76, an improvement on the 0.84 reported in September 2025. This was at a 23.2-month cut-off, at which point most Western patients have now discontinued treatment or completed two years of treatment
Previous data, released in September 2025, found that ivonescimab cut the risk of death by 24% in Asian patients; however, this was at a longer follow-up time of 32.7 months.
The drug has already gained approval in China through Akeso, where it is marketed as Yi Da Fang.
The hazard ratios for the subgroup of Western patients improved from the analysis in April 2025 and September 2025. At the most recent cutoff, the data for Western patients are now consistent in magnitude of OS benefit.
In this most recent analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase III data of ivonescimab plus chemotherapy.
Summit has already submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) based on the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of 14 November 2026.
Dr Maky Zanganeh, president and co-CEO of Summit, said: “The positive results from this latest overall survival analysis in the global HARMONi study continue to support the translation of the therapeutic profile of ivonescimab across the globe, including Western patients from North America and Europe. We have made this updated analysis available to the FDA as we continue to progress our BLA filing for the potential approval of ivonescimab in the US.”
NSCLC space sees advances
The NSCLC space has seen a number of developments in recent years. Several companies, including Johnson & Johnson (J&J), Pfizer, and Bristol Myers Squibb (BMS) debuted data in June at the American Society for Clinical Oncology (ASCO) meeting 2026.
This included BMS and BioNTech’s PDL-1/VEGF bispecific, pumitamig, from the global Phase II/III ROSETTA Lung-02 study (NCT06712316). Among the 40 response-evaluable patients enrolled on this portion of the study, who had either squamous or non-squamous disease, the overall response rate (ORR) was 70%, with two and 26 patients experiencing a complete and partial response to treatment, respectively. The highest ORR rate was in the squamous population, with nine out of 11 (81.8%) patients achieving this feat on a 1400mg dose.
A GlobalData report predicts that PD-1/PD-L1 and CTLA-4 inhibitors MSD Keytruda (pembrolizumab) and BMS’s Opdivo (nivolumab) will dominate sales of $13.9bn and $21.9bn in 2032, respectively, in the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan).
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