Sugemalimab

Last updated

Sugemalimab
Monoclonal antibody
Type Whole antibody
Source Human
Target PD-L1, (CD274)
Clinical data
Trade names Cejemly, Eqjubi
Other namesCS-1001, WBP-315
Routes of
administration 		Intravenous
Drug class Antineoplastic
ATC code
Legal status
Legal status
  • UK: POM (Prescription only)
  • EU:Rx-only [1] [2]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
UNII
KEGG

Sugemalimab, sold under the brand name Cejemly among others, is a monoclonal antibody used for the treatment of metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy. [1] It is an antineoplastic monoclonal antibody that potentiates T-cell responses, including anti-tumor responses, through blockade of PD-1 binding to PD-L1 ligands. [1]

Contents

The most common side effects include anemia (low red blood cells), increased levels of aminotransferases (liver enzymes), rash, hyperlipidemia (high blood fat levels), hyperglycemia (high blood glucose levels), hyponatremia (low blood levels of sodium), hypokalemia (low blood levels of potassium), proteinuria (protein in urine), abdominal (belly) pain, tiredness, arthralgia (joint pain), hypoesthesia (reduced sensation to touch, pain and temperature), hypothyroidism (underactive thyroid gland) and hypocalcemia (low blood levels of calcium). [1]

Sugemalimab was approved for medical use in China in December 2021, [3] [4] [5] [6] [7] the European Union in July 2024, [8] and the United Kingdom in October 2024. [9]

Medical uses

Sugemalimab, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. [1]

Mechanism of action

Sugemalimab is a fully human monoclonal antibody that targets the immunosuppressive ligand programmed cell death-1 ligand 1 (PD-L1; cluster of differentiation 274; CD274) and possesses immune checkpoint inhibitory and antineoplastic properties. [10] When administered, sugemalimab binds specifically to PD-L1, blocking its interaction with its receptor, programmed cell death 1 (PD-1). [10] This inhibition reverses T-cell inactivation induced by PD-1/PD-L1 signaling, enhancing the cytotoxic T-lymphocyte (CTL)-mediated immune response against tumor cells that express PD-L1. [10] Many types of human cancer cells overexpress PD-L1, which, when bound to PD-1 on T-cells, suppresses the immune system and enables immune evasion. [10] PD-1 itself is a transmembrane protein in the immunoglobulin superfamily expressed on activated T-cells, acting as a negative immune regulator that limits CD8-positive T-cell expansion and survival. [10] The anti-PD-L1 monoclonal antibody CS1001, modeled after natural immunoglobulin G4 (IgG4), may reduce immunogenicity and other associated toxicities. [10]

Society and culture

In May 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cejemly, intended for the first-line treatment of metastatic non-small cell lung cancer in combination with chemotherapy. [1] [11] The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH. [1] Sugemalimab was authorized for medical use in the European Union in July 2024. [1] [2]

In October 2024, the UK's Medicines and Healthcare products Regulatory Agency approved sugemalimab as part of a first-line combination treatment for lung cancer. [12] The approval was granted to CStone Pharmaceuticalsn under brand name Eqjubi. [13] Approval was based on the findings from the multicenter, randomized, double-blind phase III GEMSTONE-302 trial (NCT03789604). [14] [15] [16]

Names

Sugemalimab is the international nonproprietary name. [17]

Related Research Articles

<span class="mw-page-title-main">Cancer immunotherapy</span> Artificial stimulation of the immune system to treat cancer

Cancer immunotherapy (immuno-oncotherapy) is the stimulation of the immune system to treat cancer, improving the immune system's natural ability to fight the disease. It is an application of the fundamental research of cancer immunology (immuno-oncology) and a growing subspecialty of oncology.

<span class="mw-page-title-main">Targeted therapy</span> Type of therapy

Targeted therapy or molecularly targeted therapy is one of the major modalities of medical treatment (pharmacotherapy) for cancer, others being hormonal therapy and cytotoxic chemotherapy. As a form of molecular medicine, targeted therapy blocks the growth of cancer cells by interfering with specific targeted molecules needed for carcinogenesis and tumor growth, rather than by simply interfering with all rapidly dividing cells. Because most agents for targeted therapy are biopharmaceuticals, the term biologic therapy is sometimes synonymous with targeted therapy when used in the context of cancer therapy. However, the modalities can be combined; antibody-drug conjugates combine biologic and cytotoxic mechanisms into one targeted therapy.

<span class="mw-page-title-main">Non-small-cell lung cancer</span> Any type of epithelial lung cancer other than small-cell lung carcinoma

Non-small-cell lung cancer (NSCLC), or non-small-cell lung carcinoma, is any type of epithelial lung cancer other than small-cell lung cancer (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitive to chemotherapy, compared to small-cell carcinoma. When possible, they are primarily treated by surgical resection with curative intent, although chemotherapy has been used increasingly both preoperatively and postoperatively.

<span class="mw-page-title-main">Ipilimumab</span> Pharmaceutical drug

Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.

<span class="mw-page-title-main">Tremelimumab</span> Monoclonal antibody

Tremelimumab, sold under the brand name Imjudo, is a fully human monoclonal antibody used for the treatment of hepatocellular carcinoma. Tremelimumab is designed to attach to and block CTLA-4, a protein that controls the activity of T cells, which are part of the immune system.

Treatment of lung cancer refers to the use of medical therapies, such as surgery, radiation, chemotherapy, immunotherapy, percutaneous ablation, and palliative care, alone or in combination, in an attempt to cure or lessen the adverse impact of malignant neoplasms originating in lung tissue.

<span class="mw-page-title-main">TIGIT</span> Protein-coding gene in the species Homo sapiens

TIGIT is an immune receptor present on some T cells and natural killer cells (NK). It is also identified as WUCAM and Vstm3. TIGIT could bind to CD155 (PVR) on dendritic cells (DCs), macrophages, etc. with high affinity, and also to CD112 (PVRL2) with lower affinity.

<span class="mw-page-title-main">Nivolumab</span> Anticancer medication

Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication used to treat a number of types of cancer. This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction cancer. It is administered intravenously.

<span class="mw-page-title-main">Pembrolizumab</span> Pharmaceutical drug used in cancer treatment

Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody, more specifically a PD-1 Inhibitor, used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is administered by slow intravenous injection.

<span class="mw-page-title-main">Atezolizumab</span> Monoclonal anti-PD-L1 antibody

Atezolizumab, sold under the brand name Tecentriq among others, is a monoclonal antibody medication used to treat urothelial carcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma and alveolar soft part sarcoma, but discontinued for use in triple-negative breast cancer (TNBC). It is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1).

<span class="mw-page-title-main">Sacituzumab govitecan</span> Antibody-drug conjugate

Sacituzumab govitecan, sold under the brand name Trodelvy by Gilead Sciences, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer.

Avelumab, sold under the brand name Bavencio, is a fully human monoclonal antibody medication for the treatment of Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma.

<span class="mw-page-title-main">PD-1 and PD-L1 inhibitors</span> Class of anticancer drugs

PD-1 inhibitors and PD-L1 inhibitors are a group of checkpoint inhibitor anticancer drugs that block the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells. Immune checkpoint inhibitors are emerging as a front-line treatment for several types of cancer.

<span class="mw-page-title-main">Tislelizumab</span> Monoclonal antibody

Tislelizumab, sold under the brand name Tevimbra among others, is a humanized monoclonal antibody directed against programmed death receptor-1. It is being developed by BeiGene.

Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody medication for the treatment of squamous cell skin cancer. Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway.

Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer. Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.

<span class="mw-page-title-main">Adagrasib</span> Medication

Adagrasib, sold under the brand name Krazati, is an anticancer medication used to treat non-small cell lung cancer. Adagrasib is an inhibitor of G12C mutated KRAS GTPase. It is taken by mouth. It is being developed by Mirati Therapeutics.

<span class="mw-page-title-main">Amivantamab</span> Monoclonal antibody

Amivantamab, sold under the brand name Rybrevant, is a bispecific monoclonal antibody used to treat non-small cell lung cancer. Amivantamab is a bispecific epidermal growth factor (EGF) receptor-directed and mesenchymal–epithelial transition (MET) receptor-directed antibody. It is the first treatment for adults with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Atezolizumab/hyaluronidase, sold under the brand name Tecentriq Hybreza, is a fixed-dose combination medication used for the treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. It contains atezolizumab, a programmed death-ligand 1 (PD-L1) blocking monoclonal antibody; and hyaluronidase, an endoglycosidase. It is taken by subcutaneous injection.

Serplulimab is a monoclonal antibody used for the treatment of cancers.

References

  1. 1 2 3 4 5 6 7 8 "Cejemly EPAR". European Medicines Agency (EMA). 30 May 2024. Retrieved 1 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. 1 2 "Cejemly PI". Union Register of medicinal products. 25 July 2024. Retrieved 28 July 2024.
  3. ↑ Dhillon S, Duggan S (April 2022). "Sugemalimab: First Approval". Drugs. 82 (5): 593–599. doi:10.1007/s40265-022-01693-4. PMID   35298827.
  4. ↑ "Cstone Announced New Drug Approval Of Cejemly (Sugemalimab) In China To Potentially Reshape The Landscape Of Immuno-oncology Therapy In Lung Cancer" (Press release). CStone Pharmaceuticals. 21 December 2021. Retrieved 8 November 2024– via PR Newswire.
  5. ↑ "CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer" (Press release). CStone Pharmaceuticals. 6 June 2022. Retrieved 8 November 2024– via PR Newswire.
  6. ↑ "CStone Announces NMPA Approval of Sugemalimab for Patients with Relapsed or Refractory Extranodal NK/T-cell Lymphoma, the First Anti-PD-1/PD-L1 mAb Approved for this Indication" (Press release). CStone Pharmaceuticals. 31 October 2023. Retrieved 8 November 2024– via PR Newswire.
  7. ↑ "CStone Announces NMPA Approval of Sugemalimab as First-line Treatment for Esophageal Squamous Cell Carcinoma" (Press release). CStone Pharmaceuticals. 8 December 2023. Retrieved 8 November 2024– via PR Newswire.
  8. ↑ "CStone Announces European Commission Approval of Sugemalimab (Cejemly) as First-Line Treatment for Non-Small Cell Lung Cancer" (Press release). CStone Pharmaceuticals. 26 July 2024. Retrieved 8 November 2024– via PR Newswire.
  9. ↑ "CStone Announces MHRA Approval of Sugemalimab for First-Line Treatment of Non-Small Cell Lung Cancer (NSCLC) in the UK" (Press release). CStone Pharmaceuticals. 31 October 2024. Retrieved 8 November 2024– via PR Newswire.
  10. 1 2 3 4 5 6 "Sugemalimab (Code C154550)". NCI Thesaurus. 29 April 2024. Retrieved 1 June 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  11. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024". European Medicines Agency (EMA) (Press release). 31 May 2024. Retrieved 13 June 2024.
  12. ↑ "Sugemalimab approved to treat adult patients with non-small cell lung cancer". GOV.UK (Press release). 30 October 2024. Retrieved 8 November 2024.
  13. ↑ "MHRA approves CStone Pharmaceuticals' sugemalimab to treat lung cancer in adults". Pmlive. 4 November 2024. Retrieved 5 November 2024.
  14. ↑ "Sugemalimab Plus Chemotherapy Earns UK Approval in First-Line Metastatic NSCLC". OncLive. 31 October 2024. Retrieved 13 November 2024.
  15. ↑ "A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer". clinicaltrials.gov. Retrieved 13 November 2024.
  16. ↑ "Sugemalimab Plus Chemotherapy Earns UK Approval in First-Line Metastatic NSCLC". OncLive. 31 October 2024. Retrieved 13 November 2024.
  17. ↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl: 10665/340680 .
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.