GSK (LSE:GSK) has reported initial global clinical results for risvutatug rezetecan (Ris-Rez), an investigational B7-H3-targeted antibody-drug conjugate, showing a 61% objective response rate in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC) at the selected 8 mg/kg dose.
The findings come from the phase Ib EMBOLD PanTumour-101 trial, in which the treatment demonstrated what the company described as a manageable safety profile. The results support the dose selection for GSK’s ongoing global phase III EMBOLD SCLC-301 study.
The latest data follow positive results from a pivotal clinical study conducted in China and form part of GSK’s broader development programme evaluating Ris-Rez in cancers with limited treatment options.
Phase III Development Under Way
GSK is advancing Ris-Rez through its EMBOLD clinical development programme, which has treated more than 1,000 patients across multiple solid tumour indications.
Phase III studies are currently under way in patients with later-line extensive-stage small cell lung cancer and metastatic castration-resistant prostate cancer. The company also plans additional clinical trials evaluating the treatment in earlier disease settings.
Ris-Rez is designed to target B7-H3, a protein associated with several tumour types. The investigational therapy belongs to the antibody-drug conjugate class, which combines an antibody targeting a specific protein with a cancer treatment payload.
The global phase III EMBOLD SCLC-301 study will further evaluate Ris-Rez in relapsed ES-SCLC, building on the response and safety findings reported in the earlier clinical programme.
Regulatory Designations and Oncology Strategy
Ris-Rez has received several regulatory designations, including orphan drug and Breakthrough Therapy designations for small cell lung cancer in key markets.
These designations form part of the treatment’s regulatory development pathway as GSK continues clinical testing across multiple cancer indications.
The company is evaluating Ris-Rez in extensive-stage small cell lung cancer, where treatment options following relapse remain limited and no single established standard applies across all patients.
GSK’s oncology development activities include targeted small molecules, antibody-drug conjugates and immunotherapies, with programmes covering haematological, lung, gastrointestinal, genitourinary and gynaecological cancers.
The latest EMBOLD PanTumour-101 findings provide additional clinical response and safety data for Ris-Rez as the company progresses its phase III studies. Further trial results will be needed to establish the treatment’s efficacy and safety in the populations being evaluated.
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