GuangzhouJune 2, 2026 /PRNewswire/ — The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session officially announced the overall survival (OS) results of the Phase III clinical study HARMONi-6.Led by Professor Lu Shun from the Shanghai Chest Hospital affiliated with Shanghai Jiao Tong University School of Medicine,the results showed:The world’s first PD-1/VEGF bispecific antibody, ivonescimab, combined with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC),significantly extended patient overall survival, reducing the risk of death by 34%.
The ASCO Plenary Session is regarded as the “pinnacle” of global oncology, selecting only five breakthrough studies annually with the potential to change clinical practice.HARMONi-6, as the only Chinese lung cancer study selected for this year’s Plenary Session, achieved a zero breakthrough for China’s original First-in-Class new drug on this platform, setting a historic record in ASCO’s 61-year history, and signifying that Chinese solutions and research have received the highest international recognition. The HARMONi-6 study was simultaneously published in the top-tier international medical journal The Lancet.
HARMONi-6 Landmark Results: Ivonescimab Regimen Achieves Significantly Positive OS, Becoming a New Standard of Care for Advanced Lung Squamous Cell Carcinoma
HARMONi-6 is a randomized, double-blind, multicenter Phase III registration study led by Professor Lu Shun from the Shanghai Chest Hospital affiliated with Shanghai Jiao Tong University School of Medicine. It aims to evaluate the efficacy and safety of ivonescimab combined with chemotherapy versus tislelizumab combined with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer. A total of 532 patients were enrolled, with 63% having central-type squamous cell carcinoma, closely reflecting real-world clinical populations.
Additionally, the 12-month OS rate in the ivonescimab regimen group was 78.9%, compared to 72.2% in the control group; the 24-month OS rates were 64.7% and 48.6%, respectively. The difference in OS benefit between the two groups further widened,suggestingthat the ivonescimab regimen has a stronger immune “long-tail” effect, providing patients with more durable long-term survival benefits.
Previously announced PFS results from the HARMONi-6 study showed that the median PFS in the ivonescimab regimen group was 11.1 months, with a 40% reduction in the risk of disease progression or death (HR=0.60, 95% CI: 0.46–0.78, P<0.0001). Thus, the HARMONi-6 study achieved dual positive results for both PFS and OS, forming a complete chain of benefit evidence and further supporting the ivonescimab regimen as a new standard first-line treatment for advanced lung squamous cell carcinoma.
Addressing Treatment Challenges in Lung Squamous Cell Carcinoma: Ivonescimab Regimen Defines New Survival Benchmarks
Lung cancer ranks first in both incidence and mortality among malignant tumors in China, with an overall 5-year survival rate of around 20% for advanced patients. Lung squamous cell carcinoma accounts for approximately 30% of all lung cancers. Advanced patients have long faced severe treatment challenges: a low proportion of driver gene mutations limits the applicability of targeted therapies; traditional PD-1 inhibitor combined chemotherapy has reached an efficacy plateau; and anti-angiogenic drugs are restricted in lung squamous cell carcinoma due to high bleeding risks. Overall survival benefits for patients are insufficient, representing a significant unmet clinical need. OS is the gold standard for evaluating tumor efficacy, reflecting genuine long-term survival for patients. The positive OS results from the HARMONi-6 study indicate that ivonescimab combined with chemotherapy is significantly superior to the current standard of care (PD-1 combined chemotherapy), providing definitive, accessible, and more durable survival benefits for patients with advanced lung squamous cell carcinoma, defining a new survival benchmark for first-line treatment.
Chinese Solution Reaches the ASCO Summit, Leading a New Direction in Global Lung Cancer Treatment
Ivonescimab is a world-first PD-1/VEGF bispecific antibody independently developed by Chinese pharmaceutical company Akeso, supported by the national “Major New Drug Creation” science and technology major project.With an innovative “targeted-immunotherapy integrated” structure, it achieves efficient synergy between tumor immunity and anti-angiogenesis, overcoming the efficacy and safety limitations of traditional PD-1 combination therapies, and bridging the gap from mechanistic innovation to clinical translation.
From China’s original mechanism, to clinical validation in China, and then to presentation on internationally renowned academic platforms and publication in medical journals, HARMONi-6 outlines a clear path of continuous advancement in China’s biomedical innovation capabilities. Behind this lies the overall improvement of China’s clinical research system, innovative drug development capabilities, and tumor diagnosis and treatment levels, reflecting an era of transition for Chinese pharmaceutical innovation from “following” to “running alongside” and “leading.”
Especially in the field of lung cancer, one of the most competitive and active areas for innovative drug development globally, Chinese innovative drugs have begun to participate in defining new clinical standards. With Phase III head-to-head study data, HARMONi-6 demonstrates that China’s original PD-1/VEGF bispecific antibody regimen can not only address the clinical needs of Chinese patients but is also reshaping the international treatment landscape with globally recognized high-quality evidence.
From “Chinese data” to “global evidence,” and from “Chinese solutions” to participation in “global standards,” the success of the HARMONi-6 study at this year’s ASCO will undoubtedly become a significant milestone in the history of Chinese innovative drug development. As more original innovations emerge, Chinese clinical research and innovative drugs are poised to play an increasingly important role in the global cancer treatment landscape, contributing more treatment wisdom and innovative solutions from China to patients worldwide.