KEY TAKEAWAYS
- The phase III trial aimed to evaluate the efficacy and safety of serplulimab plus chemotherapy as a first-line treatment for squamous NSCLC.
- The primary endpoint was IRRC-assessed PFS per RECIST v1.1. Secondary endpoints included other efficacy measures, safety, and biomarker explorations.
- The study showed promising efficacy and safety in first-line sNSCLC.
Despite advances in treatment options, chemotherapy remains a mainstay for squamous non-small-cell lung cancer (sNSCLC). Combining chemotherapy with PD-1/PD-L1 inhibitors has shown promising results in first-line treatment, but the need for more effective and well-tolerated treatment options persists.
Researchers aimed to evaluate the efficacy and safety of serplulimab plus chemotherapy(carboplatin and nab-paclitaxel) as a first-line treatment for sNSCLC. The study randomly assigned patients with histologically or cytologically confirmed stage IIIB/IIIC or IV sNSCLC and no prior systemic therapy to receive intravenous serplulimab 4.5 mg/kg or placebo (up to 35 cycles).
The treatment was administered in conjunction with chemotherapy (carboplatin and nab-paclitaxel, 4-6 cycles) in 3-week cycles. Stratification for randomization included PD-L1 expression level (tumor proportion score [TPS] ≥50% vs. 1%≤ TPS <50% vs. TPS <1%), race (Asian vs. non-Asian), and disease stage (stage IIIB/IIIC vs. IV).
The primary endpoint was progression-free survival (PFS) assessed by an independent radiological review committee (IRRC) per RECIST v1.1. Secondary endpoints included various efficacy measures, safety, and explorations of biomarkers.
Among 537 randomized patients, (n=358) received serplulimab-chemotherapy, and (n=179) received placebo-chemotherapy. The median age was 63.0 years, with 90.9% being male. With a median follow-up of 31.1 months, serplulimab-chemotherapy demonstrated sustained PFS benefit compared to placebo-chemotherapy (IRRC-assessed, median, 8.3 vs. 5.7 months; HR 0.55, 95% CI 0.43-0.69).
The HR for PFS consistently favored the serplulimab-chemotherapy group across prespecified subgroups. OS was significantly extended with serplulimab (median, 22.7 vs. 18.2 months; HR 0.73, 95% CI 0.58-0.93; P=0.010, crossing the significance boundary of 0.046). Grade ≥3 adverse events(AEs) related to serplulimab or placebo were reported by (35.5%) and (31.8%) of patients, respectively.
Common events included neutrophil count decrease (14.8% vs. 14.5%), anemia (12.0% vs. 10.6%), and white blood cell count decrease (10.1% vs. 11.2%). Immune-related adverse events (irAEs) were reported by (29.6%) and (17.3%) of patients, with hypothyroidism (6.4% vs. 0.6%), rash (5.0% vs. 1.1%), and immune-mediated lung disease (4.2% vs. 0.6%) being the most frequent.
The result demonstrated that serplulimab plus chemotherapy showed promising efficacy and manageable safety as a first-line treatment for advanced sNSCLC.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/2747
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04033354
Zhou C, Hu Y, Arkania E, Kilickap S, Ying K, Xu F, Wu L, Wang X, Viguro M, Makharadze T, Sun H, Luo F, Shi J, Zang A, Pan Y, Chen Z, Jia Z, Kuchava V, Lu P, Zhang L, Cheng Y, Li W, Kang W, Wang Q, Yang G, Yu H, Li J, Zhu J. A Phase 3 Study of Serplulimab Plus Chemotherapy as First-Line Treatment for Squamous Non-small-Cell Lung Cancer (ASTRUM-004).
