Risvutatug Rezetecan Improved Survival in Relapsed Small Cell Lung Cancer

Risvutatug rezetecan (HS-20093, Hansoh Pharma) improved overall survival (OS) compared with topotecan in patients with relapsed small cell lung cancer (SCLC) after platinum-based therapy failure, according to interim results from the phase 3 ARTEMIS-008 trial. Hansoh Pharma presented the findings at the 2026 World Conference on Lung Cancer.

The randomized, open-label study assigned 461 patients 1:1 to risvutatug rezetecan or topotecan. The antibody-drug conjugate couples a fully human anti-B7-H3 monoclonal antibody to a topoisomerase I inhibitor through a cleavable tetrapeptide linker. OS was the primary endpoint. At the June 6, 2026, data cutoff, median follow-up was 12.2 months. An independent data monitoring committee reviewed the prespecified interim analysis.

Median OS was 18.5 months with risvutatug rezetecan versus 10.3 months with topotecan (hazard ratio, 0.46; 95% CI, 0.35–0.62). The corresponding 12-month survival rates were 64.5% and 43.3%. Median progression-free survival was 7.2 versus 3.0 months, and objective response rates were 58.3% versus 12.6%, respectively. Median response duration was 6.9 months with risvutatug rezetecan and 5.6 months with topotecan.

Grade 3 or higher treatment-related adverse events occurred in 60.9% versus 78.2% of patients, respectively. Grade 3 or higher platelet count decreases occurred in 13.9% versus 59.7%. Fatal hematologic events occurred only with topotecan, although treatment-related discontinuations or deaths were comparable between groups. Most interstitial lung disease events were grade 1–2 and resolved with symptomatic management; none were grade 4 or fatal.

China’s National Medical Products Administration accepted the biologics license application for risvutatug rezetecan in SCLC on September 2, 2026. The application for treatment after prior platinum-based chemotherapy failure also received Priority Review.

Source: Hansoh Pharma. 2026 WCLC | Hansoh Pharma announces interim results from phase 3 ARTEMIS-008 study of risvutatug rezetecan (HS-20093) in patients with relapsed small cell lung cancer. Press release. Hansoh Pharma; September 13, 2026. Accessed September 14, 2026.