August 25, 2026 | Miami, Florida, USA
Summit Therapeutics Inc. has announced the publication of primary analysis results from the global Phase III HARMONi trial of ivonescimab plus platinum-doublet chemotherapy in The Lancet Oncology, marking an important development for patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). The company said the publication provides peer-reviewed clinical validation for ivonescimab, an investigational bispecific antibody designed to simultaneously target PD-1 and VEGF. HARMONi evaluated the combination against placebo plus platinum-doublet chemotherapy across 114 cancer centers and hospitals in Asia, Europe and North America, addressing a patient population where treatment options remain limited after progression on EGFR-directed therapy. The publication further strengthens Summit’s global development strategy for ivonescimab while the company continues regulatory and clinical activities across multiple cancer indications.
HARMONi Delivers Significant Progression-Free Survival Benefit
The primary analysis showed that ivonescimab plus chemotherapy significantly improved progression-free survival (PFS) compared with placebo plus chemotherapy. Median PFS reached 6.8 months versus 4.4 months, respectively, corresponding to a hazard ratio of 0.52 with a 95% confidence interval of 0.41–0.66 and p<0.0001. Summit reported that the PFS benefit remained consistent across preplanned patient subgroups, supporting the reproducibility of the treatment effect within the studied population. At the primary overall survival analysis, ivonescimab plus chemotherapy demonstrated a positive trend in overall survival, although the difference had not reached statistical significance at that time. The safety profile was described as manageable and consistent with previous clinical experience, with treatment-related Grade 3–5 hemorrhage occurring in less than 1% of patients receiving ivonescimab plus chemotherapy. The publication of these findings in The Lancet Oncology provides an important independent scientific platform for the HARMONi results.
Summit Expands Ivonescimab Global Clinical Development
Summit Therapeutics is continuing to expand the clinical development of ivonescimab beyond the HARMONi study. The company is evaluating the therapy across a broad Phase III development program covering multiple oncology settings, including NSCLC, colorectal cancer and urothelial carcinoma. HARMONi-3 is evaluating ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in previously untreated metastatic NSCLC, while HARMONi-7 is evaluating ivonescimab monotherapy against pembrolizumab in patients with first-line metastatic NSCLC and high PD-L1 expression. The company has also initiated HARMONi-GI3 in first-line unresectable metastatic colorectal cancer and HARMONi-GU1 in previously untreated locally advanced or metastatic urothelial carcinoma. These programs are designed to determine whether ivonescimab’s dual-target mechanism can deliver differentiated clinical benefits across multiple tumor types and treatment settings.
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Updated HARMONi Survival Data and FDA Review Ahead
Further overall survival data from HARMONi are expected to provide additional insight into the durability of the treatment benefit. Summit previously reported that an updated June 2026 data analysis continued to show a positive overall survival trend, including an overall survival hazard ratio of 0.76 in Western patients, consistent with the broader global population. Additional updated results are scheduled for presentation at WCLC 2026 on September 15, 2026, where the company is expected to provide further details from the mature HARMONi dataset. Meanwhile, Summit’s Biologics License Application (BLA) for ivonescimab plus platinum-doublet chemotherapy in EGFR-mutated NSCLC following third-generation EGFR TKI progression has been accepted for FDA review, with a PDUFA target action date of November 14, 2026. The combination remains investigational in Summit’s licensed territories, including the United States and Europe. The latest The Lancet Oncology publication therefore represents a key scientific and regulatory milestone as Summit works toward potential commercialization of ivonescimab.
Source:Summit Therapeutics,press relese
