The GEMSTONE-301 study tested sugemalimab (1,200 mg intravenously every three weeks) versus placebo as consolidation therapy for up to 24 months after completion of concurrent or sequential chemoradiotherapy in 381 patients with locally advanced, unresectable stage-III NSCLC.
At data cutoff, with a median follow-up of 14.3 months in the sugemalimab group and 13.7 months in the placebo group, median progression-free survival (PFS) was significantly longer with sugemalimab than placebo (9.0 vs. 5.8 months; hazard ratio, 0.64; P=0.0026).
The 12-month PFS rate was 45.4% with sugemalimab versus 25.6% with placebo.
"Overall survival data were immature, but initial analysis shows an HR of 0.4, favoring sugemalimab; follow-up of patients for overall survival is ongoing," report Dr. Qing Zhou of Guangdong Lung Cancer Institute and colleagues.
Grade-3 or -4 treatment-related adverse events occurred in 9% of patients in the sugemalimab group and 6% of patients in the placebo group, the most common being pneumonitis or immune-mediated pneumonitis.
Treatment-related serious adverse events occurred in 15% patients in the sugemalimab group and 10% in the placebo group. Treatment-related deaths were reported in four patients (2%) taking sugemalimab (pneumonia in two patients, pneumonia with immune-mediated pneumonitis in one and acute hepatic failure in one patient). There were no treatment-related deaths in the placebo group.
"The safety profile was consistent with that previously reported for sugemalimab monotherapy, with no new safety signals," Dr. Zhou and colleagues report.
"Overall, efficacy and safety data from GEMSTONE-301 support the potential use of sugemalimab as an effective consolidation therapy for patients with unresectable stage III NSCLC, whose disease has not progressed after sequential or concurrent chemoradiotherapy. Longer follow-up is needed to confirm this conclusion," they write.
The GEMSTONE-302 study, published with GEMSTONE-301 in The Lancet Oncology, tested sugemalimab (1,200 mg intravenously every three weeks) versus placebo, combined with platinum-based chemotherapy, as first-line treatment in 479 patients with metastatic squamous and non-squamous NSCLC.
At the final analysis, with median follow-up of 17.8 months, PFS was significantly longer with sugemalimab than placebo (9.0 vs. 4.9 months; HR, 0.48; P<0.0001). The estimated 12-month PFS rate was 36.4% with sugemalimab versus 14.8% with placebo.
Overall survival data were immature, but favor sugemalimab over placebo (22.8 vs. 17.7 months; HR, 0.67; log-rank P=0.0064).
"Subgroup analysis suggested these benefits were maintained regardless of PD-L1 expression and NSCLC subtype. In combination with chemotherapy, sugemalimab also reduced tumor burden in more patients than placebo did, as shown by higher objective response rates with durable responses," report Dr. Caicun Zhou of Tongii University School of Medicine, in Shanghai, and colleagues.
Mirroring GEMSTONE-301, sugemalimab was well tolerated with no unexpected safety signals.
Sugemalimab plus chemotherapy "could be a new first-line treatment option for both squamous and non-squamous metastatic NSCLC," the study team concludes.
The authors of a linked comment in the journal say the two studies add "further evidence to the benefit of immunotherapy in this setting."
"Nevertheless, the presence of some co-mutations can predict an inadequacy of immunotherapy effectiveness. In future clinical trials, tumor tissue or circulating plasma DNA analysis by next-generation sequencing should be considered to help gauge checkpoint immunotherapy response and to look for therapies that can avert immune evasion," write Dr. Rafael Rosell of the Institute for Health Science Research, in Barcelona, Spain, and Dr. Peng Cao of Nanjing University, in China.
This is an active space, they note, with a total of 23 trials of PD-1 and PD-L1 antibodies now in progress, including sugemalimab, in NSCLC.
Both studies were funded by sugemalimab maker CStone Pharmaceuticals. Several authors have financial relationships with the company.
SOURCE: https://bit.ly/3H87udQ, https://bit.ly/3o3boNk and https://bit.ly/35lRNl2 The Lancet Oncology, online January 14, 2022.
By Reuters Staff
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