On April 6, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that, at the 2026 European Lung Cancer Congress (ELCC 2026), it has announced 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.
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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.
(Press release, Akeso Biopharma, APR 6, 2026, View Source [SID1234664187])