The phase 3 ARTEMIS-008 trial found that risvutatug rezetecan (Ris-Rez), an investigational antibody-drug conjugate (ADC), significantly improved overall survival compared with standard chemotherapy (topotecan) in patients with advanced or relapsed small cell lung cancer (SCLC).
The study met its primary goal, making Ris-Rez the first B7-H3-targeted ADC to show a survival benefit in a phase 3 trial for any cancer type. The treatment also improved progression-free survival, although detailed results have not yet been released.
Ris-Rez targets the B7-H3 protein, which is highly expressed on many small cell lung cancer cells but has limited expression in normal tissues. The drug delivers a topoisomerase inhibitor directly to cancer cells to help destroy them.
The safety profile was consistent with earlier studies, with no new safety concerns reported.
The drug has received multiple regulatory designations, including FDA Breakthrough Therapy and Orphan Drug status.