Miami, Florida, August 12, 2026
Summit Therapeutics announced that its partner Akeso Inc. 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 is based on positive results from the Phase 3 HARMONi-6 clinical trial, which demonstrated statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) compared with a PD-1 inhibitor plus chemotherapy. The decision represents the third NMPA-approved indication for an ivonescimab-containing regimen in China.
HARMONi-6 Demonstrates Survival Benefits
The HARMONi-6 study was a multicenter Phase 3 clinical trial conducted in China that evaluated ivonescimab combined with platinum-based chemotherapy against tislelizumab, an anti-PD-1 antibody, combined with platinum-based chemotherapy. The trial enrolled patients with locally advanced or metastatic squamous NSCLC regardless of PD-L1 expression. Results presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showed statistically significant and clinically meaningful superiority for ivonescimab in both PFS and OS. The treatment also maintained an acceptable and manageable safety profile, consistent with previous Phase 3 studies evaluating ivonescimab in combination with chemotherapy. According to Summit, HARMONi-6 is the first known Phase 3 study 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 setting. The finding could be significant for the development of next-generation immuno-oncology therapies, particularly in advanced NSCLC where PD-1 or PD-L1 inhibitor-based regimens remain an established treatment approach.
Ivonescimab Combines PD-1 and VEGF Targeting
Ivonescimab is an investigational bispecific antibody designed to combine two established approaches to cancer treatment within a single molecule: PD-1 immune checkpoint blockade and VEGF inhibition. The therapy, known as SMT112 in Summit’s licensed territories and AK112 outside those territories, has been engineered with cooperative binding characteristics intended to simultaneously target PD-1 and VEGF. Its tetravalent structure contains four binding sites and is designed to increase binding strength within the tumor microenvironment, where PD-1 and VEGF may be more highly expressed than in normal tissues. The molecule has been developed by Akeso and is currently being evaluated across a broad clinical program. More than 4,000 patients have received ivonescimab in clinical studies globally, while Akeso has reported substantially broader commercial exposure in China. The development program includes multiple Phase 3 studies investigating ivonescimab across different cancer types and treatment settings.
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Broad Phase 3 Program Supports Oncology Expansion
The latest Chinese approval adds to a growing clinical and regulatory program for ivonescimab. Summit and Akeso are evaluating the therapy in multiple Phase 3 studies across lung cancer, colorectal cancer, urothelial carcinoma and head and neck cancer, among other indications. Summit’s HARMONi study is evaluating ivonescimab with chemotherapy in patients with EGFR-mutated advanced non-squamous NSCLC, while HARMONi-3 compares ivonescimab plus chemotherapy with pembrolizumab plus chemotherapy in first-line metastatic NSCLC. HARMONi-7 is evaluating ivonescimab monotherapy against pembrolizumab in patients with first-line metastatic NSCLC and high PD-L1 expression. The company also reported positive results from four Phase 3 ivonescimab studies to date, including HARMONi, HARMONi-A, HARMONi-2 and HARMONi-6. While ivonescimab has received marketing authorization in China, it remains investigational in Summit’s licensed territories, including the United States and Europe. Summit is continuing global development efforts, including a U.S. Biologics License Application for an NSCLC indication that the FDA accepted for filing in January 2026, with a PDUFA target date of November 14, 2026.
Source: Summit Therapeutics, Akeso press release
