China-based CStone Pharmaceuticals (HKG: 2616) has announced that the European Medicine Agency (EMA) has accepted a marketing authorization application (MAA) submitted by its US-based partner EQRx for sugemalimab, a programmed death-1 (PD-1) inhibitor. The application is for the use of sugemalimab in combination with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC). This marks the second MAA filing for CStone’s PD-1 inhibitor in markets outside of Greater China.
GEMSTONE-302 Study: Positive Results
The MAA filing is based on the positive results of the GEMSTONE-302 study, a multi-center, randomized, double-blind Phase III trial. The study was designed to assess the efficacy and safety of sugemalimab in combination with chemotherapy as a first-line therapy for patients with stage IV NSCLC, compared to placebo in combination with chemotherapy. The GEMSTONE-302 study met its primary and secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS).
Sugemalimab: Drug Profile and Approvals
Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody (mAb). It has been approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy. Additionally, it is approved for use in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC. The NMPA has also accepted and granted priority review to the supplemental new drug application (sNDA) for sugemalimab in the treatment of patients with recurrent extranodal NK/T cell lymphoma (ENKTL). The drug is currently awaiting regulatory decisions in the UK, having been filed for marketing with the same indication as in the EMA.
Strategic Implications
The acceptance of the MAA for sugemalimab by the EMA represents a significant milestone for CStone Pharmaceuticals in its global expansion strategy. This development is expected to enhance the company’s market presence in Europe and contribute to the broader availability of innovative cancer treatments. By leveraging the positive results from the GEMSTONE-302 study, CStone aims to bring a new treatment option to patients with metastatic NSCLC, addressing significant unmet medical needs in this patient population.-Fineline Info & Tech
