Ivonescimab

As of October 4, 2024, 10 FDA approvals for non-small cell lung cancer (NSCLC) include neoadjuvant nivolumab plus platinum-doublet chemotherapy and adjuvant nivolumab for resectable NSCLC. Durvalumab also received approval for the same patient population. Key advances in early-stage NSCLC involve neoadjuvant immunotherapy plus chemotherapy, with significant OS and EFS benefits observed. The NeoCOAST-2 trial showed high pCR rates with various durvalumab-based combinations. Adjuvant alectinib for ALK-positive NSCLC and nivolumab for patients without EGFR/ALK mutations further enhance treatment options. In the metastatic setting, ivonescimab demonstrated a 49% reduction in disease progression risk compared to pembrolizumab. The 22nd Annual Winter Lung Cancer Conference in January 2025 will discuss these recent advancements.

Akeso Biopharma enrolled the first patient in the HARMONi-GI-01/AK112-309 phase III study for biliary tract tumour, comparing ivonescimab with durvalumab. The study aims to improve overall survival in advanced biliary tract cancers. Previous phase II results showed ivonescimab's significant antitumor activity and safety profile.

Aumolertinib improved progression-free survival in unresectable stage III NSCLC, with increased AEs in the experimental arm. New endocrine therapies and BCL-2 inhibitors are advancing treatment options, while ivonescimab showed efficacy over pembrolizumab in advanced NSCLC.

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Small cell lung cancer (SCLC) often responds well initially but later relapses. New treatments like Imdelltra, Trilaciclib, Durvalumab, and Lurbinectedin have been FDA approved. Clinical trials are ongoing for treatments like Ivonescimab, PM8002, Adebelimab, IBI3009, YL201, ZG006, and Tarlatamb, focusing on extensive stage SCLC.

Akeso Biopharma announces first patient enrollment in Phase III AK112-309 trial for biliary tract tumor, comparing ivonescimab with durvalumab. The study aims to improve overall survival in advanced biliary tract cancers, following positive Phase II results showing significant antitumor activity and safety.

Akeso Biopharma announces first patient enrollment in Phase 3 trial of ivonescimab combination for biliary tract tumors, comparing it to durvalumab. The trial aims to establish ivonescimab as a first-line therapy, with overall survival as the primary endpoint.

Akeso Biopharma announces first patient enrollment in Phase 3 trial of ivonescimab combination for first-line therapy in biliary tract tumors, comparing it to durvalumab.