Tecentriq (atezolizumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved March 2019

Specific Treatments:

extensive-stage small cell lung cancer

General Information

Tecentriq (atezolizumab) is a monoclonal antibody designed to bind with a protein called PD-L1. 

Tecentriq is specifically indicated  for use in combination with carboplatin and etoposide, for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

Tecentriq is supplied as an injection for intravenous administration. The recommended dose for use in small cell lung cancer is 1200 mg intravenously over 60 minutes every 3 weeks. When administering in combination, administer Tecentriq prior to chemotherapy when administered on the same day. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. 

Clinical Results

FDA Approval

The FDA approval of Tecentriq for ES-SCLC was based on IMpower133, a Phase III, multicenter, double-blinded, randomized placebo- controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve people with ES-SCLC. The study enrolled 403 people who were randomized equally (1:1) to receive: Tecentriq in combination with carboplatin and etoposide (Arm A), or Placebo in combination with carboplatin and etoposide (Arm B, control arm). During the treatment-induction phase, patients received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed. The co-primary endpoints were progression-free survival (PFS) as determined by the investigator using RECIST v1.1 and OS in the ITT population. Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (OS=12.3 versus 10.3 months) in the ITT population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone (PFS=5.2 versus 4.3 months).

Side Effects

Adverse effects associated with the use of Tecentriq in combination with chemotherapy for use on ES-SCLC may include, but are not limited to, the following:

fatigue/asthenia

nausea

alopecia

constipation

diarrhea

decreased appetite

Mechanism of Action

Tecentriq (atezolizumab) is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Additional Information

For additional information regarding Tecentriq or extensive-stage small cell lung cancer, please visit https://www.tecentriq-hcp.com