Atezolizumab (Tecentriq)

General information

Class/mechanism: PD-L1 antibody. Atezolizumab targets PD-L1 (programmed cell death-1 ligand 1) which is expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on T-cells. By interfering with the binding of PD-L1 to T-cell receptors, it can cause upregulation of the anti-tumor immune response.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.

Toxicity management

• Immunotherapy toxicity management

Diseases for which it is used

• Bladder cancer
• Colorectal cancer, MSI-H or dMMR
• Hepatocellular carcinoma
• Melanoma, BRAF-mutated
• Non-small cell lung cancer
• Renal cell carcinoma
• Small cell lung cancer

Diseases for which it was used

• Breast cancer, triple negative

Patient drug information

• Atezolizumab (Tecentriq) package insert
• Atezolizumab (Tecentriq) patient drug information (Chemocare)
• Atezolizumab (Tecentriq) patient drug information (UpToDate)

History of changes in FDA indication

Bladder cancer - PARTIALLY WITHDRAWN

• 5/18/2016: Granted accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy (Based on IMvigor210)
  • 4/13/2021: Approval withdrawn.
• 5/18/2016: Granted accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (Based on IMvigor210)
  • 4/13/2021: Approval withdrawn.
• 4/17/2017: Granted accelerated approval for an expanded indication for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, or have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy. (No longer needs to be used after platinum-containing chemotherapy; based on IMvigor210)
• 6/19/2018: Label revised for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy, and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering at least 5% of the tumor area), as determined by an FDA-approved test. (Conditional approval based on PD-L1 expression; based on IMvigor130)
• 6/19/2018: Label revised for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing therapy regardless of PD-L1 status.

Breast cancer, triple negative - WITHDRAWN

• 3/8/2019: Granted accelerated approval in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering at least 1% of the tumor area) (New disease entity; based on IMpassion130)
  • 10/6/2021: Approval withdrawn.

Hepatocellular carcinoma

• 5/29/2020: Approved in combination with bevacizumab for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. (New disease entity; based on IMbrave150)

Melanoma, BRAF-mutated

• 7/30/2020: Approved in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. (New disease entity; based on IMspire150)

Non-small cell lung cancer

• 10/18/2016: Approval expanded for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. (New disease entity; based on OAK)
• 12/6/2018: Approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. (Approval extended to the first-line setting and restricted to non-squamous histology; based on IMpower150)
• 12/3/2019: Approved in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. (Approval extended to three-drug combination; based on IMpower130)
• 5/18/2020: Approved for the first-line treatment of adult patients with metastatic non-small cell lung cancer (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%]), with no EGFR or ALK genomic tumor aberrations. (Approval extend to protein expression-specific monotherapy; non-squamous restriction removed; based on IMpower110)
• 10/15/2021: Approved for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells. (Based on IMpower010)

Small cell lung cancer

• 3/18/2019: Approved in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). (New disease entity; based on IMpower133)

History of changes in EMA indication

• 9/20/2017: Initial marketing authorization as Tecentriq.

Also known as

• Code names: MPDL3280A, RG7446, RO5541267
• Brand name: Tecentriq