Kaitanni (cadonilimab)

P2, N=75, Not yet recruiting, Shanghai Zhongshan Hospital

P2, N=180, Recruiting, Akeso

After multiple-line treatment including chemotherapy, targeted therapy, and immunotherapy, disease control was achieved in a case of advanced pulmonary adenocarcinoma carrying the KRAS G12C mutation by mutation-specific inhibitor therapy, and the adverse reactions to the therapy were tolerable.

P3, N=610, Completed, Akeso | Active, not recruiting --> Completed | Trial primary completion date: Apr 2025 --> Dec 2024

P3, N=445, Active, not recruiting, Akeso | Trial primary completion date: Apr 2025 --> Dec 2025

Thus, this combination therapy may offer a promising, effective, and well-tolerated treatment alternative for similar patients. Further clinical trials are warranted to validate these findings and potentially establish a new standard of care for this subset of lung cancer patients.

Patient enrollment and follow-up are expected to be completed by November 2026, with final data analysis scheduled for December 2026.ConclusionThe NeoPRAG protocol outlines an innovative, multi-modal strategy that confronts the immunological barriers of pancreatic cancer. It is hypothesized that this combination will synergistically remodel the TME, induce a potent anti-tumor immune response, and ultimately improve the survival landscape for this devastating disease by increasing conversion to resectability.

This intervention resulted in disease control, and the patient achieved 9.4 months of progression free survival (PFS). This case suggests that immunotherapy with cadonilimab could be a potential consideration for advanced NSCLC harboring acquired EGFR T790M mutation post-multiline therapy.

An 84-year-old female with unresectable, PD-L1-high (combined positive score [CPS] = 55) advanced gastric adenocarcinoma developed a rare case of recurrent immune checkpoint inhibitor associated autoimmune hemolytic anemia and thrombocytopenia after sequential treatment with three ICIs: sintilimab (anti-PD-1), cadonilimab (a bispecific PD-1/CTLA-4 antibody), and ivonescimab (a bispecific PD-1/VEGF antibody)...This case underscores the diagnostic complexity and therapeutic challenges associated with immune checkpoint inhibitor induced autoimmune hemolytic anemia in elderly patients, particularly those experiencing immunosenescence and possessing limited hematopoietic reserve. The mechanisms underlying this phenomenon remain poorly understood, highlighting the urgent need for mechanistic investigations, individualized immunotherapeutic strategies, and vigilant hematologic monitoring in vulnerable populations.

This suggests cadonilimab based therapy is a promising second-line strategy. Further prospective randomized studies are needed to confirm these findings.

P2, N=30, Not yet recruiting, Sun Yat-sen Memorial Hospital, Sun Yat-sen University​; Sun Yat-sen Memorial Hospital, Sun Yat-sen University?

Cadonilimab combined with taxane and cisplatin as first-line treatment revealed encouraging antitumor activity and manageable safety in patients with advanced ESCC. DNA methylation level might be a potential biomarker for guiding patient outcomes.