Chinese biopharmaceutical company Akeso Inc (HK:9926) said on Monday 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, multicentre 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.
In the overall population, median progression-free survival (PFS) was 7.0 months, with a 6-month PFS rate of 55.7%. Median PFS was 7.5 months in the squamous NSCLC (sq-NSCLC) subgroup and 7.4 months in the PD-L1 TPS ≥1% subgroup.
The disease control rate reached 95.2%, the objective response rate was 26.2%, and the median duration of response was 6.0 months. Patients who achieved circulating tumour DNA (ctDNA) clearance had a median PFS of 9.1 months. After the first treatment cycle, the ctDNA detection rate decreased from 1.5% to 0.5%, demonstrating the regimen's depth of anti-tumour activity at the molecular level.
According to Akeso, 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.
Cadonilimab-based regimens have previously shown promising therapeutic potential in difficult-to-treat tumours, including immunotherapy-refractory hepatocellular carcinoma (HCC) and gastric cancer. The updated data presented at ELCC 2026 provide further evidence of its additional value in treating immunotherapy-resistant diseases, beyond its benefit in the all-comer population. Cadonilimab's safety profile also makes it a highly preferable option with which other treatments can be combined to create efficacious treatment for a multitude of cancers.
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