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ESMO 2021: GEMSTONE-301 Trial of Novel PD-L1 Inhibitor in Unresectable Stage III NSCLC

By: Lauren Harrison, MS
Posted: Friday, October 15, 2021

Sugemalimab, a monoclonal antibody targeting PD-L1, demonstrated improvement in progression-free survival for some patients with stage III non–small cell lung cancer (NSCLC), in the phase III GEMSTONE-301 trial. These results were presented by Yi-Long Wu, MD, of Guangdong Provincial People’s Hospital in Guangzhou, China, during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract LBA43).

“These results provide evidence for sugemalimab as a consolidation treatment for patients with unresectable stage IIIA–C NSCLC who have not progressed following [concurrent or sequential chemoradiotherapy],” concluded the authors.

This randomized, double-blind study enrolled 381 patients with stage III NSCLC. Those enrolled had been previously treated with chemoradiotherapy but had not experienced disease progression. Patients were randomly assigned 2:1 to receive either 1,200 mg of sugemalimab or placebo every 3 weeks. Patients were stratified by concurrent or sequential chemoradiotherapy, total radiotherapy dose, and Eastern Cooperative Oncology Group performance status.

After a median follow-up of 14 months, the median progression-free survival was 9.0 months in the group receiving sugemalimab and 5.8 months in the group receiving placebo (hazard ratio = 0.64, P = .0026). The 12-month progression-free survival rates were 45% and 39% in the experimental and control groups, respectively, and the 18-month progression-free survival rates were 26% and 23%. The benefit to progression-free survival had no association to prior sequential or concurrent chemoradiotherapy. The data for overall survival were immature; however, there appeared to be a trend favoring sugemalimab (hazard ratio = 0.44). The 12-month overall survival was 89% in the sugemalimab group and 76% in the placebo group.

Grade 3 or higher treatment-emergent adverse events were observed in 24.3% of patients given sugemalimab, compared with 23.8% of patients given a placebo. 

Disclosure: For a full list of authors’ disclosures, visit oncologypro.esmo.org.



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