Hansoh Pharma's B7-H3 ADC Risvutatug Rezetecan Sets New OS Record of 18.5 Months in Second-Line SCLC at WCLC 2026

On the morning of September 13, 2026, at the inaugural Presidential Symposium of the 2026 World Conference on Lung Cancer (WCLC 2026), hosted by the International Association for the Study of Lung Cancer (IASLC) in South Korea, Hansoh Pharma’s independently developed B7-H3-targeting antibody-drug conjugate (ADC), rekunlifutotamab (development code: HS-20093), was presented as a Late-Breaking Abstract (LBA) with an oral report.

This conference presented the interim analysis results of the Phase III ARTEMIS-008 study evaluating rekilimab votumomab for recurrent small cell lung cancer (SCLC). ARTEMIS-008 is a randomized, open-label, Phase III study that enrolled a total of 461 patients, who were randomly assigned in a 1:1 ratio to receive either rekilimab votumomab or topotecan. The prespecified interim analysis, reviewed by the Independent Data Monitoring Committee (IDMC), demonstrated that the study met its primary endpoint of overall survival (OS).

The results demonstrate comprehensive and robust efficacy advantages along with a more favorable safety profile, setting a new record for the longest overall survival (OS) in second-line treatment of small cell lung cancer.As of June 6, 2026 (median follow-up: 12.2 months), rekemilimab vedotin demonstrated comprehensive and robust efficacy advantages and a more favorable safety profile compared with topotecan in the second-line treatment of small cell lung cancer. In terms of overall survival (OS), the median OS was 18.5 months vs. 10.3 months (HR=0.46; 95% CI: 0.35–0.62; p<0.001), representing a 54% reduction in the risk of death; the 12-month OS rate was 64.5% vs. 43.3%.. A consistent trend of OS benefit was observed across all prespecified subgroups, regardless of platinum resistance/sensitivity, presence or absence of brain metastases, prior treatment with PD-(L)1 inhibitors, or limited-stage/extensive-stage disease.

Progression-free survival (PFS) also showed a significant improvement: median PFS was 7.2 months vs. 3.0 months (HR=0.33; 95% CI: 0.25-0.42). Regarding tumor response metrics: ORR was 58.3% vs. 12.6%, DCR was 90.4% vs. 60.2%, and median duration of response was 6.9 months vs. 5.6 months.

In terms of safety, Ruikangli (futibatinib) demonstrated a more favorable safety profile compared to topotecan: the incidence of grade ≥3 treatment-related adverse events (TRAEs) was 60.9% vs. 78.2%, respectively. The Ruikangli group had a significantly lower incidence of hematologic toxicity, with a particularly notable difference in the incidence of grade ≥3 thrombocytopenia (13.9% vs. 59.7%). Fatal hematologic events occurred only in the topotecan group; discontinuation or death due to TRAEs was comparable between the two groups. Furthermore, the incidence of interstitial lung disease (ILD)-related events was generally consistent with the safety profile of Ruikangli observed in previous studies; most events were grade 1–2 and resolved with symptomatic management. No grade 4 or fatal ILD events were reported.

Based on these results, ARTEMIS-008 became the first positive study globally to demonstrate an overall survival (OS) benefit with a B7-H3-targeted antibody-drug conjugate (ADC) in a randomized, controlled Phase III clinical trial. Rekambivutotamab is also the first and currently only B7-H3-targeted ADC to have demonstrated statistically significant survival benefits across multiple tumor types.

Rikanglifu Tuotumab is an antibody-drug conjugate (ADC) targeting B7-H3, independently developed by Hansoh Pharma. It consists of a fully human anti-B7-H3 monoclonal antibody conjugated to a topoisomerase I inhibitor (TOP1i) payload via a cleavable tetrapeptide linker. Pivotal Phase III studies are currently underway in indications including non-small cell lung cancer, osteosarcoma, prostate cancer, and esophageal squamous cell carcinoma.

As of now, Reikang LifThe Biologics License Application (BLA) for totetumab in the treatment of small cell lung cancer (SCLC) has been accepted by the National Medical Products Administration (NMPA) of China and included in the priority review and approval program. The product has cumulatively obtained 13 regulatory designations in China, the United States, Japan, and Europe.

In December 2023, Hansoh Pharma granted GlaxoSmithKline (GSK) an exclusive global license (excluding mainland China, Hong Kong, Macao, and Taiwan) for the development, manufacturing, and commercialization of this product. GSK is currently accelerating Phase I and Phase III clinical trials of the product overseas.

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