Risvutatug rezetecan administered at 8.0 and 10.0 mg/kg every 3 weeks showed encouraging anti-tumour activity in patients with locally-advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), especially in patients with non-squamous NSCLC without actionable genomic alterations(AGAs).
The safety profile of risvutatug rezetecan was manageable and consistent with the mode of action. Grade ≥3 TRAEs and dose reductions were more common in the 10.0 versus 8.0 mg/kg cohort, respectively.
Risvutatug rezetecan has obtained breakthrough therapy designation in China for patients with advanced/metastatic non-squamous NSCLC without AGAs, who have progressed or recurred following platinum-based chemotherapy.
December 10, 2025
Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced that the encouraging phase I study results of risvutatug rezetecan (HS-20093/GSK5764227, a B7-H3-targeted antibody-drug conjugate [ADC]), in patients with locally-advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), were presented in a mini oral session at ESMO Asia 2025 (December 05-07, Singapore) on December 05 (SGT).
Details of the Mini Oral Presentation are as follows:
ARTEMIS-001 is an open label, dose escalation (Part Ia) and expansion (Part Ib) trial in Chinese adult patients with advanced solid tumours. Patients with NSCLC who progressed on or were intolerant to standard treatment were enrolled to receive risvutatug rezetecan at a dose of 8.0 mg/kg or 10.0 mg/kg every 3 weeks (Q3W) until disease progression, toxicity, loss to follow-up, or death. The primary endpoint of Phase Ia and Ib were maximum tolerated dose（MTD）/ multiple ascending dose（MAD）and objective response rate（ORR）per RECIST v1.1 by investigator，respectively.
The study results demonstrated that risvutatug rezetecan in patients with locally advanced or metastatic NSCLC:
Encouraging anti-tumor activity: A total of 167 NSCLC patients received risvutatug rezetecan 8.0 mg/kg or 10.0 mg/kg, with a median follow-up duration of 7.85 months. Anti-tumor activity was observed in both doses, particularly for patients with non-squamous NSCLC without AGAs. The confirmed ORR was 33.3% and 10.7%, median progression free survival was 7.0 months (95% CI: 4.1, 11.0) and 4.1 months (95% CI:1.8, 6.9), and median overall survival was not reached (NR) (95% CI: 10.5, NR) and 17.5 months (95% CI: 7.1, NR) in patients with non-squamous NSCLC without AGAs treated with 8.0 mg/kg and 10.0 mg/kg risvutatug rezetecan, respectively.
Manageable safety profile: Lower rates of grade ≥3 AEs, dose reductions, and treatment interruptions/discontinuation were observed in the 8.0 mg/kg vs the 10mg/kg cohort,. The most common CTCAE grade ≥3 treatment related adverse events (TRAEs) were hematological toxicities. Treatment-related grade 1/2 Interstitial Lung Disease (ILD) was reported for 2 patients (2.2%) in the 8.0 mg/kg cohort; no grade ≥3 ILD were reported. No ILD was reported in the 10 mg/kg cohort.No new safety signal was identified.
About Risvutatug Rezetecan (HS-20093/GSK5764227)
Risvutatug rezetecan, a B7-H3-targeted ADC self-developed by the Group, is composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPi) payload. As of now, risvutatug rezetecan has entered phase 3 clinical studies for the treatment of osteosarcoma indication and small cell lung cancer indication in China, and is also undergoing multiple proofs of concept (PoC) clinical studies for the treatment of non-small cell lung cancer, head and neck cancer, prostate cancer, esophageal squamous cell carcinoma, colorectal cancer and other solid tumors.
In December, 2023, the Group granted GSK an exclusive worldwide license (excluding the Chinese Mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture and commercialize risvutatug rezetecan, which is currently undergoing Phase I and Phase 3 clinical trials overseas by GSK.
Risvutatug rezetecan has now been granted eight regulatory designations by the NMPA, EMA, and FDA, underscoring the potential of this targeted ADC in treating SCLC, osteosarcoma, non-squamous NSCLC without AGAs .
About NSCLC
Lung cancer remains one of the most prevalent and lethal malignancies worldwide, accounting for approximately 18.7% of all cancer-related deaths[1]. NSCLC, which accounts for approximately 85% of all lung cancer cases, is distinguished by its molecular complexity and heterogeneity, presenting ongoing challenges to the development of effective therapies strategies[2]. Roughly 70% are non-squamous, primarily consisting of adenocarcinoma and large cell carcinoma,while the remaining 30% of NSCLC tumors exhibit squamous histology[3]. The advent of targeted therapies and ICIs has ushered a transformative era in the management of NSCLC. Targeted therapies have profoundly enhanced clinical outcomes for patients with AGAs, while ICIs have redefined the therapeutic landscape for those lacking such alterations. Despite these advances, the majority of patients eventually face disease progression, driven by either primary or acquired resistance, thereby curtailing the prospects of sustained long-term benefits.
About ESMO Asia
ESMO Asia Congress 2025 will be held from December 5-7, 2025 in the Republic of Singapore. The congress serves as a vital platform to advance cancer care through the latest scientific discoveries, innovative therapies, and evolving clinical practices. Whether you’re a clinician, researcher, or healthcare provider, this gathering offers a front-row seat to the future of oncology.
About Hansoh Pharma
Hansoh Pharma is a leading innovation-driven pharmaceutical company headquartered in China. The company is committed to addressing significant unmet medical needs in oncology, central nervous system (CNS) disorders, metabolic diseases, and autoimmune conditions. Hansoh Pharma has launched seven innovative drugs that generate product sales in the PRC, 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 three 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).
Statements
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Forward-Looking Statements
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References
1. Bray, F.; Laversanne, M.; Sung, H., et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2024, 74, 229-263.
2. 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.
3. National Cancer Institute. SEER Cancer Statistics Factsheets: Lung and Bronchus Cancer. SEER Cancer Statistics Factsheets: Lung and Bronchus Cancer. October 2023.
