Ivonescimab Wins China Approval for First-Line Squamous NSCLC

Summit Therapeutics has announced that its partner Akeso has received marketing authorization from China’s National Medical Products Administration (NMPA) for ivonescimab in combination with chemotherapy as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC).

The approval, announced by Akeso on August 12, 2026, represents the third NMPA-approved indication involving an ivonescimab-containing regimen in China since the molecule received its first approval in May 2024. Ivonescimab is a novel bispecific antibody being developed as a potential next-generation immuno-oncology treatment.

The latest authorization is supported by results from the HARMONi-6 Phase III clinical trial, a multicenter study conducted in China and sponsored by Akeso. The study evaluated ivonescimab combined with platinum-based chemotherapy against tislelizumab, a PD-1 inhibitor, combined with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC.

Patients were enrolled regardless of their PD-L1 expression status, broadening the potential relevance of the treatment approach across the advanced squamous NSCLC population.

HARMONi-6 achieved its primary objectives, demonstrating statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) for patients receiving the ivonescimab-based regimen compared with the tislelizumab and chemotherapy combination.

Overall survival findings from the trial were recently presented during a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The results have become a central component of the clinical evidence supporting ivonescimab’s development in lung cancer.

According to Summit, HARMONi-6 represents the first known Phase III trial in NSCLC, or any tumor type, to demonstrate a statistically significant and clinically meaningful overall survival benefit over an anti-PD-(L)1 antibody combined with chemotherapy in a head-to-head comparison.

The safety profile observed in HARMONi-6 was described as acceptable and manageable and remained consistent with safety findings from earlier Phase III studies evaluating ivonescimab in combination with chemotherapy.

The new approval is particularly significant given the established role of PD-1 and PD-L1 inhibitors in the treatment of advanced NSCLC. In major global markets, patients with advanced NSCLC without actionable driver mutations are commonly treated with a PD-1 inhibitor combined with platinum-based chemotherapy.

Summit said that, before the HARMONi-6 findings, there had been no known Phase III head-to-head trial in advanced NSCLC demonstrating a statistically significant and clinically meaningful improvement in overall survival over a PD-(L)1 inhibitor plus chemotherapy regimen.

Bob Duggan, Chairman and Co-CEO of Summit Therapeutics, said the Chinese approval represents another major milestone for ivonescimab and reinforces the strength of the clinical evidence generated so far. He highlighted the overall survival findings from HARMONi-6 as an important distinction for the program.

Maky Zanganeh, Ph.D., President and Co-CEO of Summit, said the results strengthen the company’s confidence in ivonescimab’s potential to move beyond current immunotherapy standards in first-line cancer treatment. Summit is continuing to work with Akeso to advance global development of the therapy in territories covered by its licensing agreement.

Michelle Xia, Ph.D., Chairwoman and CEO of Akeso, described the NMPA authorization as a significant achievement for patients and the broader oncology field. She noted that ivonescimab has now demonstrated superiority in both PFS and OS compared with a PD-1 inhibitor and chemotherapy regimen in the HARMONi-6 study.

Ivonescimab is designed as a bispecific antibody and is being investigated as a potentially differentiated immuno-oncology approach. The program is being developed across multiple cancer indications, with Summit responsible for development and commercialization activities in its licensed territories outside China.

The Chinese authorization also expands the commercial and clinical validation of the ivonescimab platform, while Summit continues to pursue development in other major markets. However, the company emphasized that ivonescimab remains an investigational therapy in Summit’s licensed territories, including the United States and Europe, and has not received regulatory approval in those markets.

The HARMONi-6 results and latest Chinese approval could therefore represent an important catalyst for Summit’s global development strategy as the company seeks to establish ivonescimab as a potential alternative to existing first-line immunotherapy approaches for advanced NSCLC.