KEY TAKEAWAYS
- The ARTEMIS-001 phase 1 trial aimed to present updated efficacy and safety results of HS-20093 in ES-SCLC from dose-escalation and dose-expansion phases.
- Efficacy endpoints were ORR, DCR, DoR, PFS, and OS.
- HS-20093 showed encouraging antitumor activity with manageable safety in patients with previously treated ES-SCLC.
The ARTEMIS-001 study is a multicenter, open-label Phase 1 trial evaluating the safety and efficacy of HS-20093 (GSK5764227), an antibody-drug conjugate targeting B7-H3, in advanced solid tumors (NCT05276609). The trial observed promising antitumor activity across various tumor types, especially in extensive-stage small cell lung cancer (ES-SCLC) during the dose-escalation phase (Jie Wang et al., JCO, 2023).
J. Wang and the team conducted a multicentre, open-label, Phase 1 study that aimed to investigate the safety and efficacy of HS-20093 in patients with advanced solid tumours, including a cohort with ES-SCLC.
Patients with ES-SCLC received either 8.0 mg/kg or 10.0 mg/kg of HS-20093 every 3 weeks until disease progression. All patients had received prior platinum-based therapy. Efficacy was assessed using objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
About 56 patients received at least 1 dose of HS-20093. Encouraging efficacy was observed, with ORR of 61.3% and 50.0% in the 8.0 mg/kg and 10.0 mg/kg dose groups, respectively. DCR was 80.6% and 95.5%, median DoR was 6.4 and 8.9 months, and median PFS was 5.9 and 7.3 months for the 8.0 mg/kg and 10.0 mg/kg doses, respectively.
The median OS was 9.8 months in the 8.0 mg/kg group and not reached in the 10.0 mg/kg group. The safety profile was consistent with previous reports, with manageable adverse events.
The study concluded that HS-20093 demonstrated encouraging antitumor activity and a manageable safety profile in patients with previously treated ES-SCLC. These findings supported further investigation of HS-20093 in a Phase 3 trial comparing its efficacy and safety with standard chemotherapy in relapsed SCLC.
The trial was sponsored by Hansoh BioMedical R&D Company.
Source: https://cattendee.abstractsonline.com/meeting/20598/presentation/3215
Clinical Trials: https://clinicaltrials.gov/study/NCT05276609
https://clinicaltrials.gov/study/NCT06498479
Wang J, Duan J, Wu L, et al. (2024). “Efficacy and Safety of HS-20093 in Extensive Stage Small Cell Lung Cancer in a Multicenter, Phase 1 Study (ARTEMIS-001).” Presented at: World Conference on Lung Cancer (WCLC); September 8, 2024; Singapore.
