A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004).

Combining immunotherapy with chemotherapy can provide improved survival in advanced squamous non-small-cell lung cancer (NSCLC) patients without targetable gene alterations. 537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC without targetable gene alterations were enrolled and randomized (2:1) to receive serplulimab 4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenously in 3-week cycles. The primary endpoint of progression-free survival (PFS) was met at the first interim analysis. At the second interim analysis, PFS benefit was maintained in serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.42–0.67). At the final analysis, serplulimab-chemotherapy significantly improved median OS compared to placebo-chemotherapy (HR 0.73, 95% CI 0.58–0.93; p = 0.010). Grade ≥3 serplulimab or placebo-related adverse events occurred in 126 (35.2%) and 58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimab to chemotherapy significantly improves survival in advanced squamous NSCLC patients, with manageable safety. [Display omitted] • First-line serplulimab plus chemotherapy improves PFS and OS • This combination shows a manageable safety profile in advanced squamous NSCLC • Serplulimab plus chemotherapy represents another treatment option for these patients Zhou et al. demonstrate the efficacy and safety of serplulimab plus chemotherapy (nab-paclitaxel and carboplatin) in first-line patients with advanced squamous non-small-cell lung cancer. Compared with placebo plus chemotherapy, serplulimab plus chemotherapy prolongs progression-free survival and overall survival, with a manageable safety profile. [ABSTRACT FROM AUTHOR]