Phase III ARTEMIS-008 Trial Shows Risvutatug Rezetecan Significantly Improves Overall Survival in Relapsed Small-Cell Lung Cancer

B7-H3-directed antibody-drug conjugate reduced the risk of death by 54% compared with topotecan
and improved progression-free survival and response rates

SEOUL, South Korea, Sept. 13, 2026 /PRNewswire/ -- Results from the randomized Phase III ARTEMIS-008 trial show that risvutatug rezetecan (Ris-Rez), a B7-H3-directed antibody-drug conjugate, significantly improved overall survival compared with topotecan in patients with relapsed small-cell lung cancer (SCLC) whose disease progressed on or after platinum-based chemotherapy. The findings were presented today at the IASLC 2026 World Conference on Lung Cancer (WCLC).

ARTEMIS-008 (NCT06498479) is a multicenter, open-label, randomized Phase III study. A total of 461 patients in China were randomized 1:1 to receive Ris-Rez 8.0 mg/kg every three weeks or topotecan 1.2 mg/m² on days 1 through 5 every three weeks. More than 80% of patients had previously received PD-(L)1 inhibitors. The primary endpoint was overall survival, with progression-free survival, objective response rate, disease control rate and safety among the key secondary endpoints.

At the June 6, 2026 data cutoff, after a median follow-up of 12.2 months, median overall survival was 18.5 months with Ris-Rez compared with 10.3 months with topotecan. Ris-Rez reduced the risk of death by 54% (HR 0.46; 95% CI, 0.35–0.62; P<0.0001), with consistent overall survival benefits across relevant subgroups.

Blinded independent central review also favored Ris-Rez across key secondary efficacy measures. Median progression-free survival was 7.2 months with Ris-Rez versus 3.0 months with topotecan (HR 0.33; 95% CI, 0.25–0.42). The objective response rate was 58.3% versus 12.6%, respectively, and the disease control rate was 90.4% versus 60.2%. Investigator-assessed outcomes were consistent with the central review findings.

Grade 3 or higher treatment-related adverse events occurred less frequently with Ris-Rez than with topotecan, at 60.9% versus 78.2%. The most common grade 3 or higher treatment-related adverse events were hematologic toxicities, including decreased neutrophil count, decreased white blood cell count, anemia, decreased lymphocyte count and decreased platelet count.

"Ris-Rez demonstrated a statistically significant and clinically meaningful overall survival benefit over topotecan in patients with SCLC that progressed after platinum-based therapy, with a favorable safety profile," said Professor Jie Wang, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences Peking Union Medical College, Beijing, China.

"These results suggest the potential of Ris-Rez to define a new standard of care in relapsed SCLC."

About the IASLC

The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.

About the WCLC

The WCLC is the world's largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc.iaslc.org/.

Contact: Chris Martin, IASLC Media Relations, [email protected]

SOURCE International Association for the Study of Lung Cancer