● Risvutatug Rezetecan ARTEMIS-001 Phase 1 Positive Readout Supports Ongoing Phase 3 Development in Refractory SCLC and Additional Pivotal Studies Planned in Lung Cancer.
March 06, 2026, Shanghai, China
Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced that results from expansion cohorts of ARTEMIS-001 (NCT05276609), a first-in-human Phase 1a/1b study evaluating risvutatug rezetecan (HS-20093 / GSK5764227) in patients with previously treated advanced solid tumors, have been published as a research article in Cancer Cell (Impact Factor: 44.5).
Risvutatug rezetecan is a B7-H3–targeted antibody–drug conjugate (ADC) under clinical development for multiple solid tumors. ARTEMIS-001 evaluated the safety, pharmacokinetics, and antitumor activity of risvutatug rezetecan in 306 patients with previously treated advanced solid tumors, including 259 patients with lung cancer. In the dose-expansion phase, patients with extensive-stage small cell lung cancer (ES-SCLC) or advanced non-small cell lung cancer (NSCLC) received risvutatug rezetecan at 8.0 mg/kg or 10.0 mg/kg intravenously once every three weeks. The primary endpoints included safety and confirmed objective response rate (cORR) per RECIST v1.1.
In lung cancer, risvutatug rezetecan demonstrated clinically meaningful activity in heavily pretreated populations. In ES-SCLC (N=65), the cORR was 52.3% in a population in which approximately 60% had received ≥2 prior lines of therapy; median duration of response (DoR) was 7.1 months, median progression-free survival (PFS) was 6.2 months and median overall survival (OS) was 13.0 months. In NSCLC (N=152), the cORR was 22.4%, with over 60% having received ≥2 prior lines of systemic therapy; median DoR was 9.7 months, median PFS was 5.5 months and median OS was 13.7 months. Notably, in patients with adenocarcinoma NSCLC without actionable genomic alterations (AGAs) treated at 8.0 mg/kg, cORR reached 33.3% with a median PFS of 7.0 months.
Across both lung cancer populations, risvutatug rezetecan demonstrated a manageable safety profile. The most frequent grade ≥3 treatment-related adverse events included decreased neutrophil count, decreased white blood cell count and anemia.
Based on the overall efficacy and safety findings from ARTEMIS-001, 8.0 mg/kg was selected for Phase 3 development, with confirmatory studies in second-line SCLC underway in China and globally.
The strength of the Phase 1 data has supported regulatory recognition in multiple jurisdictions. Risvutatug rezetecan has received Breakthrough Therapy Designation (BTD) from both the U.S. FDA and the China National Medical Products Administration (NMPA) for ES-SCLC following first-line treatment. The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation for adult patients with ES-SCLC who have progressed on or after platinum-based chemotherapy, along with Orphan Drug Designation for lung neuroendocrine carcinoma. In addition, the NMPA has granted BTD for adult patients with NSCLC without actionable genomic alterations following progression on or after platinum-based chemotherapy.
About Risvutatug Rezetecan
Risvutatug rezetecan (HS-20093/GSK5764227) is a B7-H3–targeted ADC discovered and developed by Hansoh Pharma. It comprises a fully human anti-B7-H3 monoclonal antibody conjugated to a number of topoisomerase I inhibitor (TOP1i) payloads (an exatecan derivative, HS-9265) via tetrapeptide-based cleavable linkers.
The program has entered Phase 3 clinical development in China for osteosarcoma and SCLC and is also being evaluated in multiple proof-of-concept studies across additional indications, including NSCLC, head and neck cancer, prostate cancer, esophageal squamous cell carcinoma and colorectal cancer.
In December 2023, Hansoh Pharma granted GSK an exclusive worldwide license, excluding Chinese mainland, Hong Kong, Macau and Taiwan, to develop, manufacture and commercialize risvutatug rezetecan. The program is being advanced globally by GSK, with Phase 1 and Phase 3 clinical studies ongoing outside China.
About SCLC and NSCLC
Lung cancer remains the leading cause of cancer-related mortality worldwide, with approximately 2.48 million new cases diagnosed globally in 2022 [1]. SCLC accounts for approximately 15% of cases and is characterized by rapid progression and poor prognosis, with a 5-year survival rate of approximately 3% in extensive-stage disease [2–4]. NSCLC, which represents approximately 85% of cases [5], comprises a heterogeneous group of malignancies driven by diverse molecular alterations [6].
Platinum-based chemotherapy, with or without immunotherapy, remains the standard first-line treatment for ES-SCLC [7,8], while treatment options beyond first-line have limited durability. In NSCLC, targeted therapies and immune checkpoint inhibitors have improved outcomes in selected populations; however, disease progression due to primary or acquired resistance remains common. Significant unmet medical need persists across both SCLC and NSCLC.
About Hansoh Pharma
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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References
1. World Health Organization. International Agency for Research on Cancer. U.S. Cancer Fact Sheet. Accessed August 2025.
2. Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiol Biomarkers Prev. 2019;28(10):1563-1579. doi:10.1158/1055-9965.EPI-19-0221
3. Rudin CM, Brambilla E, Faivre-Finn C, Sage J. Small-cell lung cancer. Nat Rev Dis Primers. 2021;7(1):3. Published 2021 Jan 14. doi:10.1038/s41572-020-00235-0
4. SEER Small Cell Carcinoma of the Lung and Bronchus SEER 5-Year Relative Survival Rates. Data from SEER 2012-2018
5. National Cancer Institute. SEER Cancer Statistics Factsheets: Lung and Bronchus Cancer. SEER Cancer Statistics Factsheets: Lung and Bronchus Cancer. October 2023.
6. Chen, Z.; Fillmore, C.M.; Hammerman, P.S.; Kim, C.F.; Wong, K.K. Non-small-cell lung cancers: a heterogeneous set of diseases. Nat Rev Cancer 2014, 14, 535-546.
7. Kim SY, Park HS, Chiang AC. Small Cell Lung Cancer: A Review. JAMA. 2025;333(21):1906-1917. doi:10.1001/jama.2025.0560
8. Horn L, Mansfield AS, Szczęsna A, et al. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018;379(23):2220-2229. doi:10.1056/NEJMoa1809064
