Sorrento (Socazolimab) – Cervical Cancer | HongKong DengYue Medicine

Socazolimab Application Scope

• Recurrent or metastatic cervical cancer (China, approved Dec 2023)

• First-line extensive-stage small-cell lung cancer (ES-SCLC) in combination with carboplatin + etoposide (Phase III completion, showing OS benefit)

 

 Characteristics

• Ingredients:

  • Fully human IgG₁λ monoclonal antibody targeting PD-L1 („ZKAB‑001”, STI‑A1014)

• Properties:

  • Immune checkpoint inhibitor; blocks PD-L1/PD-1 interaction and mediates ADCC

• Packaging Specification:

  • Solution for intravenous infusion; dosage investigated at 5 mg/kg IV every 3 weeks (max 2 years)

• Storage:

  • Not publicly specified — standard for monoclonal antibodies (likely refrigeration required).

• Expiry Date:

  • Not publicly disclosed; refer to commercial product labeling.

• Executive Standard:

  • Approved by China’s NMPA; breakthrough designation in cervical cancer

• Approval Number:

  • Marketing approval granted by China’s NMPA on Dec 21, 2023

• Date of Revision:

  • Most recent Phase III data submitted or presented by mid-2024

• Manufacturer:

  • Developed by Sorrento Therapeutics; licensed to Lee’s Pharmaceutical / Zhaoke Oncology (Greater China)

Guidelines for the Use of Socazolimab

• Dosage and Administration:

  • ES-SCLC (Phase III):

    • 5 mg/kg IV every 21 days alongside carboplatin + etoposide, up to 2 years

  • Cervical Cancer:

    • Dosage based on clinical-trial protocols (not fully disclosed); typical dosing regimen likely similar to other anti‑PD‑L1 mAbs.​

• Adverse Reactions:

  • Common (from trials):

    • Hematologic AEs: anemia, neutropenia, thrombocytopenia (≥95%)

    • Alopecia, rash, liver-enzyme elevations, pruritus, peripheral neurotoxicity, anorexia, emesis

  • Safety Profile:

    • Generally manageable (mostly grade 1–2); no new grade 4–5 events in cervical cancer study

• Contraindications: Serious hypersensitivity to Socazolimab or excipients — standard contraindication for mAbs

• Precautions:

  • Monitor for immune‑mediated toxicities (e.g., pneumonitis, colitis, hepatitis)

  • Observe for infusion‑related reactions and serious infections

Interactions

• Drug Interactions:​ No major pharmacokinetic interactions reported; caution when combined with chemotherapy and immunomodulators due to additive immunosuppression

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.