On September 2, 2025 Akeso (9926.HK) reported the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1) (Press release, Akeso Biopharma, SEP 2, 2025, View Source [SID1234655673]). This Phase III trial is being conducted in China.
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Ivonescimab has previously shown significant positive results in the randomized, double-blind, controlled Phase III study (HARMONi-2), where it was compared head-to-head with pembrolizumab. These results led to its approval as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC), marking its second approved indication. In addition, the Phase III trial of ivonescimab in combination with chemotherapy compared to tislelizumab combined with chemotherapy as a first-line treatment for squamous NSCLC, also delivered significant positive outcomes. These results highlight ivonescimab’s strong clinical breakthroughs. Whether compared to PD-1 monotherapy, PD-1 plus chemotherapy (current standard therapies for various cancers), or VEGF-related treatments, ivonescimab has consistently demonstrated its ability to drive clinical innovation.
Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings:
Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints):
First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial)
First-line squamous NSCLC (versus tislelizumab + chemotherapy)
NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies)
First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy)
First-line PD-L1-high expressing NSCLC (versus pembrolizumab)
IO-resistant NSCLC
Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT)
Phase III trials for core immuno-oncology indications (first-line therapy ):
First-line biliary tract cancer (versus durvalumab + chemotherapy)
First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab
Phase III trials for cold tumors and more:
First-line triple-negative breast cancer (TNBC)
First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases)
First-line pancreatic cancer
Additional global Phase III trials are in advanced stages of planning
An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data that enable rapid transition to further registrational studies worldwide.
Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy.
For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab worldwide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics.