GSK reports phase Ib data for Ris-Rez in small cell lung cancer

GSK has released initial global clinical data for its investigational antibody-drug conjugate, risvutatug rezetecan (Ris-Rez), in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC). Findings from the phase Ib portion of the EMBOLD PanTumour-101 trial, presented at the ESMO Congress in Madrid, demonstrated a 61% confirmed objective response rate among patients treated with an 8 mg/kg dose.

The results supplement recent pivotal data from a separate study in China and provide a basis for the 8 mg/kg dosing regimen currently being evaluated in GSK’s ongoing global phase III EMBOLD SCLC-301 study. The company is positioning Ris-Rez as a potential therapeutic option for a patient population that typically faces rapid disease progression and limited clinical alternatives.

Safety monitoring indicated that 42% of the high-dose cohort experienced grade 3 or higher treatment-related adverse events, primarily hematological in nature. GSK is developing the drug under a licensing agreement with Hansoh Pharma and intends to pursue clinical trials across multiple oncology indications to address high unmet medical needs.