SHANGHAI, April 20, 2026-Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced the results of the Phase 1 study evaluating risvutatug rezetecan (HS-20093/GSK5764227) plus adebrelimab in patients with advanced nsqNSCLC without AGAs at the American Association for Cancer Research Annual Meeting 2026 (AACR 2026), held from April 17-22 in San Diego, California.

Risvutatug rezetecan is a B7-H3–targeted antibody–drug conjugate (ADC) under clinical development for multiple solid tumors. Adebrelimab is a fully human anti-PD-L1 lgG4 mAb and is approved for the first-line treatment of extensive stage small cell lung cancer (ES-SCLC) in China. At AACR 2026, data from an expansion cohort of the phase 1 ARTEMIS-101 study evaluating risvutatug rezetecan plus adebrelimab in patients with previously treated nsq-NSCLC without AGAs were presented as an oral presentation. 

ARTEMIS-101 is an open-label, multi-center phase 1 study, evaluating the safety, efficacy, pharmacokinetics and immunogenicity of risvutatug rezetecan in combination with other anti-cancer agents in patients with advanced solid tumors.

In the presented cohort, risvutatug rezetecan 8.0 mg/kg and adebrelimab 20.0 mg/kg was administered intravenously once every three weeks to patients with previously treated nsq-NSCLC without AGAs until disease progression or unacceptable toxicities. The efficacy endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS) assessed per RECIST v1.1 criteria, and overall survival (OS).

Study results showed:

● These results demonstrated encouraging anti-tumour activity with the combination of risvutatug rezetecan plus adebrelimab with a confirmed ORR of 47.1%, DCR of 94.1%, median DoR of 12.6 months, median PFS was 14.0 months (32.4% event rate). The OS data is immature.

● Risvutatug rezetecan plus adebrelimab demonstrated a manageable safety profile, with no treatment emergent adverse events (TEAEs) leading to death reported. The most frequent grade ≥3 TEAEs included decreased white blood cell count, decreased neutrophil count, decreased lymphocyte count and anemia.

Based on the results from ARTEMIS-101, risvutatug rezetecan in combination with adebrelimab has obtained approval to be included as a Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for locally advanced or metastatic non-squamous NSCLC without AGAs that has progressed or relapsed after platinum-based chemotherapy.

In addition, previously reported data from risvutatug rezetecan monotherapy trial (ARTEMIS-001), published in Cancer Cell, showed a cORR of 33.3% with a median PFS of 7.0 months at 8.0 mg/kg in patients with previously treated nsq-NSCLC without AGAs^[1].

Based on these encouraging preliminary safety and efficacy results, a phase 3 study of this combination in nsq-NSCLC patients without AGAs is currently ongoing in China (CTR20260641/NCT07464327).

Details of the oral presentation are as follows:

◆ Presentation Title: Combination of risvutatug rezetecan and adebrelimab in previously treated advanced nsq-NSCLC without actionable genomic alterations: Results from ARTEMIS-101, a phase 1 study

◆ Abstract Presentation Number: CT038

◆ Presentation Date/Time: April 19, 2026 5:00-5:15 PM (PT)

◆ Place: San Diego, California

◆ Presenter: Dr. Runbo Zhong Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine 

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, SCLC and NSCLC, and is also being evaluated in multiple proof-of-concept studies across additional indications, including 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 nsq-NSCLC without AGAs

Lung cancer remains the leading cause of cancer-related mortality ^[2], with approximately 40% of cases being adenocarcinoma, which represents the majority of nsq-NSCLC^[3], and around 40% of adenocarcinoma lacking actionable genomic alterations (AGAs) ^[4].

In nsq-NSCLC without AGAs, immune checkpoint inhibitors have improved outcomes in selected populations; however, disease progression due to primary or acquired resistance remains common. After progression on first-line treatment, the options for subsequent treatment are limited ^[3], significant unmet medical need persists across nsq-NSCLC without AGAs.

References

1.Duan J, et al. HS-20093, a B7-H3-targeted antibody-drug conjugate in lung cancer: Results from the ARTEMIS-001 phase 1a/b trial. Cancer Cell. 2026 Apr; 44:846-857.

2.Freddie Bray, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.

3.Narjust Duma, et al. Non-Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment. Mayo Clin Proc. 2019 Aug;94(8):1623-1640.

4.Ilaria Attili, et al. Co-Occurring Driver Genomic Alterations in Advanced Non-Small-Cell Lung Cancer (NSCLC): A Retrospective Analysis. J Clin Med. 2024 Jul 31;13(15):4476.