Trial shows risvutatug rezetecan significantly improves overall survival in relapsed small-cell lung cancer

by International Association for the Study of Lung Cancer

edited by Gaby Clark, reviewed by Robert Egan

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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 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."

Key medical concepts

Topotecan

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OncologyPulmonary medicine Provided by International Association for the Study of Lung Cancer Who's behind this story?

Gaby Clark

MA in English, copy editor since 2021 with experience in higher education and health content. Dedicated to trustworthy science news. Full profile →

Robert Egan

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Citation: Trial shows risvutatug rezetecan significantly improves overall survival in relapsed small-cell lung cancer (2026, September 12) retrieved 13 September 2026 from https://medicalxpress.com/news/2026-09-trial-risvutatug-rezetecan-significantly-survival.html This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.