HONG KONG, April 6, 2026 -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that, at the 2026 European Lung Cancer Congress (ELCC 2026), it reported updated results with a median follow-up of 21.45 months from a prospective, open-label, single-arm, multicenter Phase Ib/II study evaluating cadonilimab in combination with anlotinib and docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who progressed after prior PD-(L)1 inhibitor-based therapy.
Cadonilimab is the world’s first approved bispecific antibody for cancer immunotherapy, having received marketing approval in 2022. In extensive real-world clinical practice and multiple Phase III studies, it has demonstrated clinically meaningful benefit across all patient populations regardless of PD-L1 expression status,addressing a significant unmet medical need and earning broad recognition from physicians and patients.
Cadonilimab-based regimens have previously shown promising therapeutic potential in difficult-to-treat tumors, including immunotherapy-refractory hepatocellular carcinoma (HCC) and gastric cancer. The updated data presented at ELCC 2026 now provide further robust evidence of cadonilimab’s important additional value in treating immunotherapy-resistant diseases, beyond its well-established benefit in the all-comer population. Just as importantly, cadonilimab’s consistent safety profile makes it a highly preferable backbone with which other treatments can be combined to create efficacious treatment for a multitude of cancers.
In this difficult-to-treat population of patients with immunotherapy-resistant advanced NSCLC, the cadonilimab combination regimen demonstrated clinically meaningful anti-tumor activity, durable disease control, and a manageable safety profile, supporting its potential as a new second-line treatment option.
Key Findings from the Phase Ib/II Study (Median Follow-Up: 21.45 Months):
- Progression-Free Survival (PFS):In the overall population, median PFS was 7.0 months, with a 6-month PFS rate of 55.7% .
- Consistent Benefit Across Subgroups: Median PFS was 7.5 months in the squamous NSCLC (sq-NSCLC) subgroup and 7.4 months in the PD-L1 TPS ≥1% subgroup.
- Disease Control and Response Durability: The Disease Control Rate (DCR) reached 95.2%; the Objective Response Rate (ORR) was 26.2%, and the median Duration of Response (DoR) was 6.0 months. Patients who achieved circulating tumor DNA (ctDNA) clearance had a median PFS of 9.1 months. After the first treatment cycle (C1), the ctDNA detection rate decreased from 1.5% to 0.5%, demonstrating the regimen’s depth of anti-tumor activity at the molecular level.
- Safety Profile: The triple combination of cadonilimab, anlotinib, and docetaxel was well tolerated, with a grade ≥3 treatment-related adverse event (TRAE) rate of 14.0%. No treatment-related deaths were reported.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.
