China-based CStone Pharmaceuticals (HKG: 2616) has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted the marketing authorization application (MAA) submitted by its US-based partner EQRx for sugemalimab in combination with chemotherapy as a first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). In 2021, the programmed death-1 (PD-1) inhibitor sugemalimab was granted an Innovation Passport designation in the UK through the Innovative Licensing and Access Pathway (ILAP).
Clinical Data and Study Results
The MAA for sugemalimab is supported by clinical data from the CStone-sponsored GEMSTONE-302 study, a multicenter, randomized, double-blind, Phase III study to evaluate the efficacy and safety of sugemalimab in combination with chemotherapy in first-line treatment-naïve 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 improvement in progression-free survival (PFS) and overall survival (OS), respectively.
Drug Profile and Approvals
Sugemalimab, a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody (mAb), 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 and in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC. In addition, the NMPA of China has 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). A registrational study of sugemalimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric adenocarcinoma (GC)/gastro-esophageal junction (GEJ) adenocarcinoma has met its primary endpoint. Another registrational study assessing sugemalimab plus chemotherapy as a first-line treatment in esophageal squamous cell carcinoma (ESCC) has completed patient enrollment.
Future Prospects and Strategic Implications
The acceptance of the MAA by the MHRA marks a significant milestone for CStone Pharmaceuticals in expanding the global reach of sugemalimab. By leveraging its innovative drug development capabilities and strategic partnerships, CStone aims to address significant unmet medical needs in oncology and improve patient outcomes through advanced therapeutic solutions.-Fineline Info & Tech
