Akeso initiates Phase II trial of a novel TROP2/Nectin-4 bispecific ADC combined with Ivonescimab, advancing its oncology pipeline in NSCLC
Executive summary: Akeso announced that the first patient has been dosed in a Phase II clinical study (AK146D1-201) of its TROP2/Nectin-4 bispecific ADC (AK146D1) combined with Ivonescimab for advanced NSCLC. The trial tests a novel bispecific ADC-immunotherapy combination that could address unmet needs in NSCLC and strengthen Akeso’s pipeline, with potential implications for competitive positioning and future licensing deals.
Who is involved: Akeso, Inc. (9926.HK) as sponsor; Ivonescimab as the partner immuno‑oncology agent; clinical sites enrolling patients with advanced NSCLC.
Likely next: Interim safety and efficacy data are expected in the second half of 2027; positive outcomes could trigger a Phase III program and regulatory discussions with the FDA/EMA in 2028.
Akeso dosed the first patient in a Phase II study evaluating AK146D1, its internally developed TROP2/Nectin-4 antibody-drug conjugate, in combination with the anti‑PD‑L1 antibody Ivonescimab for advanced non‑small cell lung cancer. The trial marks a step forward in the company’s strategy to develop targeted ADCs for solid tumors and to explore immunotherapy‑ADC combinations. Success could differentiate Akeso’s offering in a crowded NSCLC therapeutics landscape and potentially attract partnership interest.
Timeline
- — Akeso Doses First Patient in Phase II Study of Novel TROP2/Nectin-4 Bispecific ADC (AK146D1) in Combination with Ivonescimab for Advanced NSCLC (PR Newswire)
- — Kelun-Biotech Announces Phase III Study of Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as First-Line Treatment for PD-L1-Negative Non-Squamous NSCLC Met Primary Endpoint (PR Newswire)
- — Immutep Provides Clinical Update in 1st line NSCLC: Positive Mature Overall Survival Data from INSIGHT-003 and Update from TACTI-004 (GlobeNewswire)
- — InxMed Announces Publication in The Lancet Respiratory Medicine Featuring Promising Anticancer Activity of Ifebemtinib in Combination with Garsorasib in First-Line non-small cell lung cancer (NSCLC) Harboring KRAS G12C Mutation (PR Newswire)
Analysis — what this means
Likely next events
- Interim efficacy and safety data from AK146D1-201 expected H2 2027
- If positive, Akeso may initiate a Phase III trial in 2028
- Potential regulatory discussions with FDA/EMA on bispecific ADC pathway in 2028
Sectors affected
- Oncology
- Biopharmaceutical ADC development
- NSCLC therapeutics
Regulatory implications
- FDA may require separate safety assessment for the bispecific ADC construct
- EMA likely to request biomarker‑driven subgroup analysis for TROP2/Nectin-4 expression
- Combination with Ivonescimab may trigger additional review of immuno‑oncology combo guidance
Historical parallels
- Approval of Enhertu (fam‑trastuzumab deruxtecan) for HER2‑low breast cancer 2020 demonstrated ADC success in solid tumors
- Sacituzumab govitecan approval for metastatic triple‑negative breast cancer 2021 showed ADC plus chemotherapy benefit
Key entities
Sources
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