On October 19, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") and its partner Summit Therapeutics Inc. reported an international multicenter Phase II clinical study (SMT112-216 / AK112-216 / NCT07877194).
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Built on Akeso’s first-in-class immuno-oncology (IO) cornerstone therapy ivonescimab (PD-1/VEGF bispecific antibody), the study will assess the efficacy and safety of multiple treatment regimens, including the combination of ivonescimab with Akeso’s first-in-class bispecific antibody cadonilimab (PD-1/CTLA-4 bispecific antibody), in previously untreated patients with advanced clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer. Participants will be randomized to receive ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or the established international standard-of-care comparator regimen of nivolumab plus ipilimumab.
Cadonilimab is the world’s first approved immuno-oncology bispecific antibody and the only PD-1/CTLA-4 bispecific antibody to have received regulatory approval. It is currently approved for three indications: first-line gastric cancer, first-line cervical cancer, and recurrent or metastatic cervical cancer.
Cadonilimab is being evaluated in 13 Phase III/registrational clinical studies, including two international multicenter trials. In addition, dozens of Phase I/II studies have been conducted across more than 30 tumor types, including renal cell carcinoma, demonstrating robust anti-tumor activity and a favorable safety profile.
Currently, regimens combining a PD-1 inhibitor with a CTLA-4 inhibitor, such as nivolumab plus ipilimumab, and those combining a PD-1 inhibitor with a tyrosine kinase inhibitor (TKI), such as pembrolizumab plus axitinib, represent established first-line standards of care for advanced renal cell carcinoma internationally. Building on ivonescimab as a cornerstone therapy, combinations with the next-generation IO agent cadonilimab, a PD-1/CTLA-4 bispecific antibody, and additional agents will allow further exploration of the synergistic, complementary and differentiated effects across distinct targets and mechanisms of action. This approach has the potential to further improve clinical benefit and offer patients with advanced renal cell carcinoma more diverse and precise novel treatment options.
Early clinical studies have shown that both cadonilimab and ivonescimab demonstrate promising antitumor activity with manageable safety profiles in renal cell carcinoma, providing a strong rationale for further evaluation of their combination in advanced disease.
Earlier this year, Summit announced a clinical trial collaboration to evaluate the safety and efficacy of ivonescimab in combination with casdatifan, a HIF2α inhibitor from Arcus Biosciences, in ccRCC, including first-line metastatic disease.
(Press release, Akeso Biopharma, OCT 19, 2026, View Source [SID1234673584])