Kaitanni (cadonilimab)

P2, N=27, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Trial primary completion date: Apr 2026 --> Dec 2026

P1/2, N=37, Active, not recruiting, Hao Zeng | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Oct 2025 --> Apr 2026

P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028

P3, N=380, Recruiting, Sun Yat-sen University | Active, not recruiting --> Recruiting

P2, N=100, Recruiting, Akeso | Not yet recruiting --> Recruiting

In dMMR EC, the conventional ipilimumab-nivolumab combination yields higher objective response rates (ORR ≈ 63%) than PD-1 monotherapy (ORR ≈ 48%) but is associated with a substantially increased incidence of grade ≥ 3 immune-related adverse events (≈ 23% vs. ≈ 12%)...In contrast, for patients with mismatch repair-proficient (pMMR) tumors, the evidence firmly supports alternative regimens, such as lenvatinib plus pembrolizumab, over dual PD-1/CTLA-4 blockade. Navigating the evolving landscape of immunotherapy in EC requires a nuanced, patient-centric approach. The integration of novel bispecific antibodies may soon simplify the balance between efficacy and toxicity, but until then, treatment selection remains a deliberate process, underscoring the gynecologic oncologist's pivotal role in personalizing care.

Its economic advantage is most pronounced in patients with high PD-L1 expression and at lower drug prices. These findings provide quantitative evidence supporting reimbursement negotiations and future pricing strategies for cadonilimab in global markets.

Cadonilimab (AK104) is a first-in-class bispecific antibody targeting programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)...Immune-related AEs occurred in 8 patients (30.8%) in the cadonilimab group and 6 patients (23.1%) in the PD-1 inhibitor group. Compared to PD-1 inhibitor plus chemotherapy, cadonilimab plus chemotherapy significantly improved PFS and OS with a manageable safety profile in the first-line treatment of advanced G/GEJ cancer with PD-L1 CPS <5 in a real-world setting.

The regimen included ifosfamide, liposomal doxorubicin hydrochloride, cadonilimab, and anlotinib capsules...Here we present a successfully treated case of this tumor type originating in the stomach. This case may serve as a reference for future management of such tumors.

P2, N=32, Active, not recruiting, Sun Yat-sen University | Not yet recruiting --> Active, not recruiting

Further large-scale, high-quality randomized controlled trials are needed to validate these findings and define the optimal treatment strategy. https://www.crd.york.ac.uk/PROSPERO, identifier CRD420251089855.

P1/2, N=110, Active, not recruiting, Akeso | Recruiting --> Active, not recruiting