Ewopharma is pleased to report that sugemalimab, licensed from partner CStone Pharmaceuticals, has received a I, A recommendation in the European Society for Medical Oncology (ESMO) Early and Locally Advanced Non-Small-Cell Lung Cancer Living Guideline.
This recommendation supports sugemalimab for consolidation therapy in patients with unresectable Stage III non-small cell lung cancer (NSCLC), who have not progressed after concurrent or sequential chemoradiotherapy. ESMO’s recommendation is expected to significantly facilitate market access for sugemalimab in the European Union and other regions, thus expanding patient reach and offering further treatment options.
In February 2025, ESMO included sugemalimab in combination with chemotherapy in its guidelines with a I, A rating for the first-line treatment of both squamous and non-squamous metastatic (Stage IV) NSCLC. Both NSCLC indications, for which sugemalimab is approved in the EU and UK, are therefore now included in the ESMO guidelines. Sugemalimab is recommended for:
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.
The EC and MHRA have approved sugemalimab for two indications:
This recommendation supports sugemalimab for consolidation therapy in patients with unresectable Stage III non-small cell lung cancer (NSCLC), who have not progressed after concurrent or sequential chemoradiotherapy. ESMO’s recommendation is expected to significantly facilitate market access for sugemalimab in the European Union and other regions, thus expanding patient reach and offering further treatment options.
In February 2025, ESMO included sugemalimab in combination with chemotherapy in its guidelines with a I, A rating for the first-line treatment of both squamous and non-squamous metastatic (Stage IV) NSCLC. Both NSCLC indications, for which sugemalimab is approved in the EU and UK, are therefore now included in the ESMO guidelines. Sugemalimab is recommended for:
- Combination with platinum-doublet chemotherapy as first-line treatment for non-oncogene-addicted stage IV patients with squamous NSCLC, performance status (PS) 0-1, regardless of tumour PD-L1 status and without contraindications for immune checkpoint inhibitors (ICI),
- Combination with platinum-based chemotherapy as first-line treatment for non-oncogene-addicted stage IV patients with non-squamous NSCLC, PS 0-1, regardless of tumour PD-L1 status and without contraindications for ICI, and
- Consolidation therapy for up to 24 months in patients with stage III NSCLC, who are EGFR wild-type and lack ALK or ROS1 genomic aberrations, following concurrent or sequential chemoradiotherapy without disease progression.
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.
The EC and MHRA have approved sugemalimab for two indications:
- In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations; and
- Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
