Hansoh Pharma: Ris‑Rez (risvutatug rezetecan) ARTEMIS‑008 shows overall survival benefit in Chinese SCLC patients
- ARTEMIS‑008 met its primary endpoint, showing statistically significant and clinically meaningful overall survival improvement versus topotecan in advanced or relapsed SCLC in China.
- These are the first positive phase III overall survival data reported for any B7‑H3‑targeted antibody‑drug conjugate.
- Safety profile was consistent with prior Ris‑Rez findings and no new safety signals were identified.
- Hansoh will use the data for regulatory submission in China; GSK holds exclusive rights outside Greater China and expects pivotal EMBOLD SCLC‑301 data next year.
Phase III ARTEMIS‑008 outcome
The pivotal ARTEMIS‑008 trial conducted in China met its primary endpoint of overall survival (OS) in patients with advanced or relapsed small‑cell lung cancer (SCLC). Risvutatug rezetecan (Ris‑Rez) demonstrated statistically significant and clinically meaningful OS improvements versus the standard‑of‑care comparator topotecan, with consistent benefit observed across key secondary endpoints including progression‑free survival.
Clinical and target significance
This is the first positive phase III OS result reported for a B7‑H3‑targeted antibody‑drug conjugate (ADC) in any tumour type. The sponsor notes B7‑H3 is highly expressed in SCLC tumours and views the data as supportive of B7‑H3 as a potential target across lung cancer and other solid tumours.
Safety and regulatory plans
The safety profile in ARTEMIS‑008 was consistent with prior Ris‑Rez findings and no new safety signals were identified. Hansoh Pharmaceutical will use these data for regulatory submission in China.
Global development
GSK holds exclusive global rights to develop Ris‑Rez outside mainland China, Hong Kong, Macau and Taiwan. GSK’s clinical programme includes studies in lung, prostate and other solid tumours, and the global phase III EMBOLD SCLC‑301 trial in relapsed extensive‑stage SCLC has pivotal data expected next year.
Source: GSK