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Atezolizumab and hyaluronidase-tqjs

(Tecentriq Hybreza®)

Tecentriq Hybreza®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 1,875 mg atezolizumab and 30,000 units hyaluronidase/15 mL [125 mg/2,000 units per mL])
Drug ClassProgrammed death-ligand 1 (PD-L1) blocking antibodies and endoglycosidase
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test
  • Indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA approved test, with no EGFR or ALK genomic tumor aberrations
  • Indicated in combination with bevacizumab, paclitaxel, and carboplatin, for the first line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations
  • Indicated in combination with paclitaxel protein-bound and carboplatin for the first line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations
  • Indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy
  • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq Hybreza
  • Indicated in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
  • Indicated in combination with bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy
  • Indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma a as determined by an FDA-approved test
  • Indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS

Latest News

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • Drug Exposure Metrics: Observed trough serum concentration (C_trough) was 89 µg/ml (coefficient of variation (CV): 43%) for Atezolizumab subcutaneous (SC) and 85 µg/ml (CV: 33%) for Atezolizumab intravenous (IV), with a geometric mean ratio (GMR) of 1.05 [90% confidence interval (CI): 0.88–1.24]. Model-predicted area under the curve (AUC(0-21 d)) was 2907 µg·d/ml (CV: 32%) for SC and 3328 µg·d/ml (CV: 20%) for IV, with a GMR of 0.87 [90% CI: 0.83–0.92].
  • Efficacy Outcomes: Progression-free survival (PFS) had a hazard ratio of 1.08 (95% CI: 0.82–1.41) for SC versus IV formulations. The objective response rate (ORR) was 12% for Atezolizumab SC and 10% for Atezolizumab IV.
  • The incidence of anti-atezolizumab antibodies was higher in the SC group (19.5%) compared to the IV group (13.9%).
  • No new safety concerns were identified for atezolizumab SC compared to IV administration.
  • There is no population types or subgroups information available in the reviewed studies.