Posted: Friday, March 4, 2022
Results from a recent phase III trial indicate that consolidation therapy with the anti–PD-L1 antibody sugemalimab may be effective in patients with locally advanced and unresectable stage III non–small-cell lung cancer after definitive concurrent or sequential chemoradiotherapy. Study author Yi-Long Wu, MD, of Guangdong Academy of Medical Sciences, Guangzhou, China, and colleagues published the findings of this study, GEMSTONE-301, in The Lancet Oncology.
“A statistically significant and clinically meaningful improvement in progression-free survival was observed with sugemalimab compared with placebo,” the authors commented. “The safety profile was consistent with that previously reported for sugemalimab monotherapy, with no new safety signals observed.”
The trial enrolled 381 patients who had not experienced disease progression after concurrent or sequential chemoradiotherapy, assigning them randomly to receive either 1,200 mg of sugemalimab (n = 255) or placebo (n = 126). The median age of all patients was 61 years; 92% were men, and 33% had received sequential chemoradiotherapy. Most patients (69%) had squamous cell carcinoma.
After a median follow-up of 14.3 and 13.7 months for the sugemalimab and placebo cohorts, respectively, median progression-free survival was significantly higher with sugemalimab than with placebo (9.0 months [95% confidence interval [CI] = 8.1–14.1 months] vs. 5.8 months [95% CI = 4.2–6.6 months], stratified hazard ratio = 0.64 [95% CI = 0.48–0.85], P = .0026). However, neither the median duration of response nor the minimum number of events required for overall survival analysis had been reached, rendering the data immature.
The authors reported that grade 3 or 4 treatment-related adverse events occurred in 9% of patients receiving sugemalimab and in 6% receiving the placebo, the most common being pneumonitis or immune-mediated pneumonitis. They also noted that despite the treatment’s significant improvement in progression-free survival, longer follow-up is needed to confirm the study’s results.
Disclosure: For full disclosures of the study authors, visit thelancet.com.