Year: 2022
Type: article
Abstract: Lung cancer is the leading cause of cancer-related mortality globally (1,2).Over the last decade, the treatment of advanced non-small cell lung cancer (NSCLC) has changed dramatically with the emergence of immune checkpoint inhibitors (ICIs).A growing number of phase III clinical trials have demonstrated that the first-line combination of ICIs with standard chemotherapy improves survival outcomes in patients with metastatic NSCLC, regardless of programmed death-ligand 1 (PD-L1) expression (3-7).Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody that is developed for the treatment of various advanced solid tumors and lymphoma (8).The GEMSTONE-302 trial did what has been done in numerous trials over the past 5 years.It was a randomized, double-blind phase III clinical trial, demonstrating that the addition of sugemalimab to chemotherapy significantly improved survival outcomes among patients with treatment-naïve metastatic NSCLC without actionable genomic tumor alterations including epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements.Based on the encouraging results of GEMSTONE-302, sugemalimab plus chemotherapy has been approved for the first-line treatment of metastatic squamous and nonsquamous NSCLC without EGFR and ALK mutations in China (9).Did we really expect a different result?Herein, we will compare the efficacy and safety data of GEMSTONE-302 to other clinical trials that led to several ICIs being approved for the first-line treatment of metastatic NSCLC in the US (Table 1234567).The GEMSTONE-302 trial included patients from 35 Chinese centers, with squamous histology consisting of 40% of the study population in both the sugemalimab and placebo arms.The primary endpoint was progressionfree survival (PFS), and the secondary endpoints included overall survival (OS) and objective response rate (ORR) (10).Four hundred and seventy-nine patients with histologically confirmed metastatic squamous and non-squamous NSCLC, regardless of PD-L1 expression level, were randomly assigned 2:1 to the sugemalimab arm (n=320) and the placebo arm (n=159).Patients in the sugemalimab arm received sugemalimab plus platinum-based chemotherapy (carboplatin and paclitaxel for squamous, or carboplatin and pemetrexed for non-squamous NSCLC) for four cycles, followed by either sugemalimab (squamous) or sugemalimab plus pemetrexed (non-squamous) as the maintenance therapy.Patients in the placebo arm received placebo plus the same platinum-based chemotherapy regimens for four cycles, followed by maintenance therapy with either placebo alone (squamous) or placebo plus pemetrexed (non-squamous).Among the patients in the placebo arm, crossover to the sugemalimab arm at the time
Source: Chinese Clinical Oncology
DOI: 10.21037/cco-22-103
Institutions: AdventHealth Orlando, AdventHealth
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4309515815