Benefit, safety of serplulimab demonstrated in extensive-stage SCLC
CHICAGO – For patients with extensive-stage small cell lung cancer, a first-line treatment of serplulimab plus chemotherapy provided significant benefit and safety profile compared with chemotherapy alone.
“For the past 30 years, etoposide-platinum has been the standard first-line treatment [for small cell lung cancer],” Ying Cheng, MD, professor in the department of thoracic oncology at Jilin Cancer Center in Changchun, China, said during her presentation at ASCO Annual Meeting. “PD-L1 inhibitors plus chemotherapy marked a milestone in the first-line treatment of extensive stage small cell lung cancer.”
Between Sept. 12, 2019, and April 27, 2021, investigators of this international, double-blind, multicenter, phase 3 trial, randomized 585 patients to receive serplulimab (Shanghai Henlius Biotech Inc.; n = 389) or placebo (n = 196). The primary endpoint was overall survival, and the secondary endpoint was progression-free survival, objective response rate, duration of response and safety.
Interim analysis showed a median follow-up of 12.3 months, a “significantly prolonged” median overall survival in the serplulimab group compared with the placebo group (15.4 vs. 10.9 months; HR = 0.63; 95% CI, 0.49-0.82) and a “significantly longer” median progression-free survival (5.8 vs. 4.3 months; HR = 0.47; 95% CI, 0.38-0.59, according to the abstract.
The data also demonstrated improvements in efficacy, with an objective response rate of 80.2% for serplulimab compared with 70.4% or placebo and a duration of response of 5.6 and 3.2 months, respectively.
Grade 3 or higher treatment-emergent adverse events related to serplulimab had a rate of 33.2% (n = 129) compared with 27.6% (n = 54) for placebo. The incidence of immune-related events was 37% in the serplulimab group compared with 18.4% in the placebo group. The researchers noted that four deaths occurred that may have been related to the study drugs.
“Serplulimab plus chemotherapy showed consistent benefits in overall survival, progression-free survival, overall response rate and duration of response, and long-term benefits were also observed,” Cheng said.
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Cheng, Y, et al. Serplulimab, a novel anti-PD-1 antibody, plus chemotherapy versus chemotherapy alone as first-line treatment for extensive-stage small-cell lung cancer: An international randomized phase 3 study. Presented at: ASCO Annual meeting; June 3-7, 2022; Chicago.
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