GSK’s licensor Hansoh Pharmaceutical has reported positive topline results from ARTEMIS‑008, a pivotal phase III trial of risvutatug rezetecan (Ris‑Rez) in patients with advanced or relapsed small‑cell lung cancer (SCLC) in China, demonstrating a statistically significant and clinically meaningful improvement in overall survival versus topotecan, while GSK advances the B7‑H3‑targeted antibody‑drug conjugate globally across multiple tumor types, including lung and prostate cancers.
The trial also demonstrated consistent benefit across key secondary endpoints, including progression‑free survival. Safety findings were in line with earlier studies of Ris‑Rez, and no new safety signals were identified. Hansoh plans to use the ARTEMIS‑008 data to support a regulatory submission in China.
Ris‑Rez is a B7‑H3‑targeted antibody‑drug conjugate (ADC) that links a fully human anti‑B7‑H3 monoclonal antibody to a topoisomerase inhibitor payload. The ARTEMIS‑008 outcome represents the first positive phase III overall survival result reported for a B7‑H3‑directed ADC in any tumor type, underscoring the target’s potential relevance across solid tumors.
GSK holds exclusive rights to develop and commercialize Ris‑Rez outside mainland China, Hong Kong, Macau, and Taiwan. The company is evaluating the ADC in a broad clinical program that includes lung cancer, prostate cancer, and other solid tumors. This includes the global phase III EMBOLD SCLC‑301 trial in relapsed extensive‑stage SCLC, with pivotal data expected next year.
Most patients with extensive‑stage SCLC relapse after initial therapy and face limited options and poor prognosis. B7‑H3 is highly expressed in SCLC, and the ARTEMIS‑008 results add to evidence supporting further development of Ris‑Rez in this setting.
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