Sugemalimab
Sugemalimab is CStone's PD-L1 antibody, approved in China for first-line lung cancer with chemotherapy and after chemoradiotherapy in stage III disease, and the first China-developed PD-L1 antibody to win European approval.
Overview
GEMSTONE-302 (479 patients, squamous and non-squamous metastatic NSCLC) gave a progression-free survival hazard ratio of 0.50 versus placebo plus platinum chemotherapy, the basis of the NMPA approval in December 2021. GEMSTONE-301 added unresectable stage III NSCLC after concurrent or sequential chemoradiotherapy in 2022, and relapsed or refractory extranodal NK/T-cell lymphoma followed. The European Commission approved sugemalimab with platinum chemotherapy for first-line metastatic NSCLC without EGFR, ALK, ROS1 or RET alterations in July 2024, making it the first anti-PD-L1 antibody from a Chinese company approved in the EU.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas: how tumours escape and what closes the route · Lines of therapy.
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Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2021 | First-line metastatic squamous and non-squamous NSCLC with platinum chemotherapy (GEMSTONE-302) |
| China | 2022 | Unresectable stage III NSCLC without progression after chemoradiotherapy (GEMSTONE-301) |
| EU | 2024 | First-line metastatic NSCLC with platinum chemotherapy, no sensitising EGFR, ALK, ROS1 or RET alterations |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Sugemalimab" OR ABSTRACT:"Sugemalimab" OR TITLE:"Cejemly" OR ABSTRACT:"Cejemly" OR TITLE:"CS1001" OR ABSTRACT:"CS1001") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sugemalimab, not a curated reading list.
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