Drug updated on 4/26/2024
| Dosage Form | Injection (intravenous; 840 mg/14 mL [60 mg/mL], 1200 mg/20 mL [60 mg/mL]) |
| Drug Class | Programmed death-ligand1 blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS.
- 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.
- 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.
Summary
- Atezolizumab (Tecentriq) is indicated for the treatment of various conditions including unresectable or metastatic Alveolar Soft Part Sarcoma (ASPS), non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer, hepatocellular carcinoma, and BRAF V600 mutation-positive melanoma. Its effectiveness varies across these indications.
- The information was derived from 35 systematic reviews/meta-analyses focused on the efficacy, safety, and application of atezolizumab in different populations and subgroups.
- In patients with Unresectable Hepatocellular Carcinoma (uHCC), a combination therapy involving atezolizumab and bevacizumab has been effective even in those with CTP-A or CTP-B cirrhosis. This combination therapy also showed longer progression-free survival rates compared to tyrosine kinase inhibitors.
- For metastatic NSCLC patients, especially when combined with chemotherapy agents like bevacizumab, Tecentriq displayed improved overall survival rates as well as tolerability. It particularly outperformed monotherapy and chemotherapy in enhancing both objective response rates and progression-free survival when used for PD-L1 high expression tumors.
- Studies have revealed manageable safety profiles for Tecentriq alone or in combination therapies without any significant increase in grade ≥3 adverse events compared to control arms or chemotherapy treatments indicating its relative safety during clinical treatments.
- Subgroup considerations reveal varying levels of efficacy based on factors such as PD-L1 levels, CNS metastases presence, smoking history among advanced NSCLC patients treated using combinations of chemotherapy drugs along with Tecentriq. However, combinations involving Bevacizumab consistently provided favorable PFS across all PD-L1 levels.
- When directly compared against other systemic therapies such as Lenvatinib for advanced HCC, Tecentriq did not show superiority in terms of objective response rates, disease control rate, or progression-free survival, indicating the need for further head-to-head trials.
- Toxicity analysis placed combinations involving Tecentriq as generally safe when compared with other treatments. However, attention should be paid to incidences of hepatotoxicity and pyrexia, which were noted as adverse events.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tecentriq (atezolizumab) prescribing information. | 2024 | Genentech, Inc., South San Francisco, CA |