CStone Submits Application to the European Medicines Agency for New Indication of Sugemalimab in Stage III Non-Small Cell Lung Cancer
The submission is supported by data from the GEMSTONE-301 Phase III trial, a multicenter, randomized, double-blind study evaluating sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC post-CRT. Results published in The Lancet Oncology demonstrated:
- 36% reduction in risk of disease progression or death, significantly improved progression-free survival (PFS).
- 56% reduction in risk of death, with a strong positive trend toward overall survival (OS) benefit.
- Consistent clinical benefits across subgroups, regardless of prior CRT modality (concurrent or sequential).
- Favorable safety profile, no new safety signals identified.
Dr.
About Sugemalimab
The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.
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- In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC;
- For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy;
- For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
- In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
- In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.
About CStone
CStone's robust pipeline features 16 high-potential candidates, including first-in-class and best-in-class assets such as antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. The company further distinguishes itself through a seasoned leadership team with comprehensive expertise in drug development—from preclinical research and clinical trials to manufacturing, business development, and commercialization.
For more information about CStone, please visit www.cstonepharma.com.
IR contact: ir@cstonepharma.com
PR contact: pr@cstonepharma.com
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