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Durvalumab

Durvalumab

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Product Details

　　【Indications】

Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody indicated for the treatment of adult patients with:

  • Non-Small Cell Lung Cancer (NSCLC):

    • Resectable Stage II/III:​ In combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent as adjuvant treatment after surgery (tumors ≥4 cm and/or node-positive, and no known EGFR mutations or ALK rearrangements).

    • Unresectable Stage III:​ As consolidation therapy for patients whose disease has not progressed following concurrent platinum-based chemoradiotherapy.

    • Metastatic:​ In combination with tremelimumab-actl and platinum-based chemotherapy as first-line treatment (no sensitizing EGFR mutations or ALK genomic aberrations).

  • Small Cell Lung Cancer (SCLC):

    • Limited-Stage (LS-SCLC):​ As single-agent consolidation therapy for patients whose disease has not progressed following concurrent platinum-based chemoradiotherapy.

    • Extensive-Stage (ES-SCLC):​ In combination with etoposide and carboplatin or cisplatin as first-line treatment.

  • Biliary Tract Cancer (BTC):​ In combination with gemcitabine and cisplatin for first-line treatment of locally advanced or metastatic disease.

  • Hepatocellular Carcinoma (HCC):​ In combination with tremelimumab-actl for the treatment of unresectable adult patients.

  • Endometrial Cancer:​ In combination with carboplatin and paclitaxel for adult patients with primary advanced or recurrent mismatch repair deficient (dMMR) disease, followed by single-agent durvalumab.

  • Muscle-Invasive Bladder Cancer (MIBC):​ In combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent adjuvant treatment after radical cystectomy.

【Recommended Dosage】

  • Administer only as an intravenous infusion over at least 60 minutes. Do not administer as an intravenous push or bolus.

  • Resectable NSCLC (Neoadjuvant + Adjuvant):

    • Weight ≥30 kg:​ Neoadjuvant: 1500 mg with chemotherapy every 3 weeks for up to 4 cycles. Adjuvant: 1500 mg as a single agent every 4 weeks for up to 12 cycles.

    • Weight <30 kg:​ Neoadjuvant: 20 mg/kg with chemotherapy every 3 weeks for up to 4 cycles. Adjuvant: 20 mg/kg as a single agent every 4 weeks for up to 12 cycles.

  • Unresectable Stage III NSCLC (Consolidation):

    • Weight ≥30 kg:​ 10 mg/kg every 2 weeks or​ 1500 mg every 4 weeks.

    • Weight <30 kg:​ 10 mg/kg every 2 weeks.

  • Metastatic NSCLC (with Tremelimumab-actl & Chemotherapy):

    • Weight ≥30 kg:​ Cycles 1-4: 1500 mg with tremelimumab-actl 75 mg and chemotherapy every 3 weeks. From Cycle 5: 1500 mg single agent with histology-based pemetrexed every 4 weeks. At Week 16 (with 6th dose of durvalumab), give 5th dose of tremelimumab-actl 75 mg.

    • Weight <30 kg:​ Cycles 1-4: 20 mg/kg with tremelimumab-actl 1 mg/kg and chemotherapy every 3 weeks. From Cycle 5: 20 mg/kg single agent with histology-based pemetrexed every 4 weeks. At Week 16 (with 6th dose of durvalumab), give 5th dose of tremelimumab-actl 1 mg/kg.

  • Limited-Stage SCLC (Consolidation):

    • Weight ≥30 kg:​ 1500 mg every 4 weeks.

    • Weight <30 kg:​ 20 mg/kg every 4 weeks.

  • Extensive-Stage SCLC (with Chemotherapy):

    • Weight ≥30 kg:​ Cycles 1-4: 1500 mg with chemotherapy every 3 weeks. From Cycle 5: 1500 mg single agent every 4 weeks.

    • Weight <30 kg:​ Cycles 1-4: 20 mg/kg with chemotherapy every 3 weeks. From Cycle 5: 10 mg/kg single agent every 2 weeks.

  • Biliary Tract Cancer (with Chemotherapy):

    • Weight ≥30 kg:​ Cycles 1-8: 1500 mg with chemotherapy every 3 weeks. From Cycle 9: 1500 mg single agent every 4 weeks.

    • Weight <30 kg:​ Cycles 1-8: 20 mg/kg with chemotherapy every 3 weeks. From Cycle 9: 20 mg/kg single agent every 4 weeks.

  • Unresectable Hepatocellular Carcinoma (with Tremelimumab-actl):

    • Weight ≥30 kg:​ Day 1: 1500 mg with a single dose of tremelimumab-actl 300 mg. Then: 1500 mg single agent every 4 weeks.

    • Weight <30 kg:​ Day 1: 20 mg/kg with a single dose of tremelimumab-actl 4 mg/kg. Then: 20 mg/kg single agent every 4 weeks.

  • dMMR Endometrial Cancer (with Chemotherapy then Single Agent):

    • Weight ≥30 kg:​ Cycles 1-6: 1120 mg with carboplatin and paclitaxel every 3 weeks. From Cycle 7: 1500 mg single agent every 4 weeks.

    • Weight <30 kg:​ Cycles 1-6: 15 mg/kg with carboplatin and paclitaxel every 3 weeks. From Cycle 7: 20 mg/kg single agent every 4 weeks.

  • Muscle-Invasive Bladder Cancer (with Chemotherapy then Single Agent):

    • Weight ≥30 kg:​ Neoadjuvant: 1500 mg with gemcitabine and cisplatin every 3 weeks for 4 cycles prior to surgery. Adjuvant: 1500 mg single agent every 4 weeks for up to 8 cycles post-surgery.

    • Weight <30 kg:​ Neoadjuvant: 20 mg/kg with gemcitabine and cisplatin every 3 weeks for 4 cycles prior to surgery. Adjuvant: 20 mg/kg single agent every 4 weeks for up to 8 cycles post-surgery.

【Adverse Reactions】

  • Resectable NSCLC (with Chemotherapy):​ Most common (≥20%) were anemia, nausea, constipation, fatigue, musculoskeletal pain, rash.

  • Unresectable Stage III NSCLC (Single Agent Consolidation):​ Most common (≥20%) were cough, fatigue, pneumonia/radiation pneumonitis, upper respiratory infection, dyspnea, rash.

  • Metastatic NSCLC (with Tremelimumab-actl & Chemotherapy):​ Most common (≥20%) were nausea, fatigue, musculoskeletal pain, decreased appetite, rash, diarrhea.

  • Limited-Stage SCLC (Single Agent Consolidation):​ Most common (≥20%) were pneumonia/radiation pneumonitis, fatigue.

  • Extensive-Stage SCLC (with Chemotherapy):​ Most common (≥20%) were nausea, fatigue/asthenia, alopecia.

  • Biliary Tract Cancer (with Chemotherapy):​ Most common (≥20%) were fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, pyrexia.

  • Unresectable Hepatocellular Carcinoma (with Tremelimumab-actl):​ Most common (≥20%) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, abdominal pain.

  • dMMR Endometrial Cancer (with Chemotherapy then Single Agent):​ Most common (≥20%) were peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, hypomagnesemia, increased ALT, increased AST, diarrhea, vomiting, cough, hypokalemia, dyspnea, headache, increased alkaline phosphatase.

  • Muscle-Invasive Bladder Cancer (with Chemotherapy then Single Agent):​ Most common (≥20%) were decreased hemoglobin, neutropenia, increased creatinine, hyponatremia, nausea, increased ALT, hypocalcemia, thrombocytopenia, fatigue, hyperkalemia, lymphopenia, increased AST, constipation, hypomagnesemia, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting, abdominal pain.

【Pharmacological Action】

Programmed death-ligand 1 (PD-L1) is expressed on tumor cells and tumor-associated immune cells within the tumor microenvironment, and its expression can be induced by inflammatory signals (e.g., IFN-γ). PD-L1 inhibits T-cell function and activation through interaction with PD-1 and CD80 (B7.1), thereby reducing cytotoxic T-cell activity, proliferation, and cytokine production.

Durvalumab is a human IgG1κ monoclonal antibody that binds to PD-L1 and blocks its interaction with PD-1 and CD80. By blocking PD-L1/PD-1 and PD-L1/CD80 interactions, it counteracts immune suppression. Durvalumab does not induce antibody-dependent cellular cytotoxicity (ADCC).

In xenograft mouse models co-engrafted with human tumors and immune cells, durvalumab blockade of PD-L1 enhanced T-cell activation in vitro and reduced tumor volume.

【Storage】

Store in a refrigerator at 2°C to 8°C. Protect from light. Do not freeze. Do not shake.