Akeso's Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Combination Therapy for PD-(L)1 Resistant NSCLC Showcased in Oral Presentation at 2024 Asian Conference on Lung Cancer

Core Insights - Akeso, Inc. announced positive results from a Phase Ib/II clinical study of cadonilimab for advanced non-small cell lung cancer (NSCLC) patients who progressed after prior PD-(L)1 inhibitor treatment [1][2][3] Study Overview - The AK104-IIT-018 study is a prospective, open-label, single-arm, multicenter trial conducted across four centers in China, initiated in February 2023 [3] - The study enrolled patients with unresectable, incurable locally advanced or metastatic NSCLC who had previously received PD-1/L1 inhibitors and platinum-based chemotherapy [3][4] Efficacy Results - The treatment demonstrated a 6-month progression-free survival (PFS) rate of 56.9%, with a median PFS of 6.5 months, and a disease control rate (DCR) of 94.0% [2][5][7] - The overall objective response rate (ORR) was 30.3%, significantly higher than the 14% observed with docetaxel monotherapy [6] Patient Demographics - As of May 31, 2024, 46 patients were enrolled, with 41.3% having non-squamous NSCLC and 58.7% having squamous NSCLC [4] - 10.9% of patients had brain metastasis, 6.5% had liver metastasis, and 23.9% had bone metastasis [4] Safety Profile - The combination therapy of cadonilimab, anlotinib, and docetaxel was well-tolerated, with manageable adverse events and a favorable safety profile [8] Treatment Context - Current treatment options for advanced, driver gene-negative NSCLC after first-line immunotherapy are limited, with standard chemotherapy showing an ORR of 14%-17% and a 6-month PFS rate of approximately 30% [9] - Cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, shows potential as a new treatment option for immune-resistant NSCLC [9][10] Company Background - Akeso is a biopharmaceutical company focused on innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas, including cancer [12] - The company has developed a unique integrated R&D innovation system and has 22 candidates in clinical trials, with 5 new drugs commercially available [12]