Hong Kong, April 6, 2026
Promising Results in Immunotherapy-Resistant NSCLC
In a significant advancement for lung cancer immunotherapy, Akeso, Inc. has presented updated clinical data at the European Lung Cancer Congress (ELCC 2026) demonstrating the efficacy of its cadonilimab-based combination therapy in patients with advanced non-small cell lung cancer (NSCLC) who progressed after prior PD-(L)1 inhibitor treatment. The Phase Ib/II multicenter study, with a median follow-up of 21.45 months, evaluated cadonilimab in combination with anlotinib and docetaxel, targeting a highly resistant patient population with limited treatment options.
Results showed a median progression-free survival (PFS) of 7.0 months and a 6-month PFS rate of 55.7%, indicating clinically meaningful disease control. Importantly, consistent benefits were observed across subgroups, including squamous NSCLC and patients with PD-L1 expression ≥1%, reinforcing the therapy’s broad applicability and potential as a second-line treatment option.
Strong Disease Control and Molecular Response
The study further highlighted robust anti-tumor activity, with a disease control rate (DCR) of 95.2% and an objective response rate (ORR) of 26.2%, demonstrating the regimen’s ability to achieve durable clinical responses. The median duration of response (DoR) was 6.0 months, reflecting sustained therapeutic benefit in a population typically associated with rapid disease progression. A key differentiator of the study was the incorporation of circulating tumor DNA (ctDNA) analysis, which revealed a significant reduction in ctDNA detection rates from 1.5% to 0.5% after the first treatment cycle, indicating deep molecular response and tumor burden reduction.
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Patients achieving ctDNA clearance experienced improved outcomes, with a median PFS of 9.1 months, further validating ctDNA as a predictive biomarker for treatment response. These findings position cadonilimab as a next-generation bispecific antibody therapy capable of delivering enhanced efficacy through dual immune checkpoint targeting.
Favorable Safety Profile Supports Combination Strategy
Safety remains a critical consideration in combination therapies, and the cadonilimab regimen demonstrated a manageable and well-tolerated safety profile. The incidence of Grade ≥3 treatment-related adverse events (TRAEs) was 14.0%, with no treatment-related deaths reported, underscoring its suitability for broader clinical use. Cadonilimab, recognized as the world’s first approved bispecific antibody for cancer immunotherapy, has already demonstrated clinical benefit across multiple tumor types, including hepatocellular carcinoma and gastric cancer.
Its consistent safety profile and combinability make it an ideal backbone therapy for multi-drug regimens, enabling the development of more effective and personalized cancer treatments. The combination with anti-angiogenic therapy (anlotinib) and chemotherapy (docetaxel) represents a multi-mechanistic approach, targeting tumor growth, immune evasion, and angiogenesis simultaneously.
Expanding Role of Bispecific Antibodies in Oncology
The success of cadonilimab underscores the growing importance of bispecific antibody platforms in modern oncology, offering enhanced immune activation and improved therapeutic outcomes compared to traditional monoclonal antibodies. As noted in the clinical summary within the provided document, cadonilimab has shown consistent efficacy regardless of PD-L1 expression, addressing a key limitation of existing immunotherapies. Akeso’s robust pipeline, supported by its Tetrabody platform and AI-driven drug development, continues to drive innovation across multiple disease areas, including cancer, autoimmune disorders, and metabolic diseases.
With over 50 innovative assets and multiple candidates in clinical development, the company is rapidly establishing itself as a global leader in next-generation biologics. The latest findings from ELCC 2026 reinforce cadonilimab’s potential to transform treatment paradigms for immunotherapy-resistant cancers, offering new hope for patients with advanced NSCLC and beyond.
Source: Akeso press release
