Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody.
Tecentriq is specifically indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
Tecentriq is specifically indicated for the treatment of metastatic non-small cell lung cancer in patients 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 these aberrations prior to receiving Tecentriq.
Tecentriq is specifically indicated in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations
Tecentriq is specifically indicated as a first-line treatment for adults with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
Tecentriq is supplied as a solution for intravenous injection. The recommended dose is 1200 mg as an intravenous infusion over 60 minutes every 3 weeks.
The FDA approval of Tecentriq was based on a single-arm clinical trial involving 310 patients with locally advanced or metastatic urothelial carcinoma. This trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors (objective response rate). The study also looked at the difference in effect based on “positive” versus “negative” expression of the PD-L1 protein on patients’ tumor-infiltrating immune cells. In all patients, 14.8 percent of experienced at least a partial shrinkage of their tumors, an effect that lasted from more than 2.1 to more than 13.8 months at the time of the response analysis. In patients who were classified as “positive” for PD-L1 expression, 26 percent experienced a tumor response, compared to 9.5 percent of patients who were classified as “negative” for PD-L1 expression.
non-small cell lung cancer
The FDA approval of Tecentriq for metastatic non-small cell lung cancer was based on results from the randomized Phase III OAK and Phase II POPLAR studies. OAK was a global, multicenter, open-label, randomized, controlled study which enrolled 1,225 patients who were randomized 1:1 to receive either docetaxel (75 mg/m2 intravenous infusion) or Tecentriq (1200 mg intravenous infusion) every three weeks. Results from OAK showed that Tecentriq helped subjects in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months). The study enrolled subjects regardless of their PD-L1 status and included both squamous and non-squamous disease types. POPLAR enrolled 287 subjects. The study showed Tecentriq doubled the likelihood of survival OS in subjects whose cancer expressed the highest levels of PD-L1 compared with docetaxel chemotherapy. An improvement in survival was also observed in subjects who had medium and high or any level of PD-L1 expression.
adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations
The FDA approval of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations was based on the Phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS]=18.6 versus 13.9 months) in the intention-to-treat wild-type (ITT-WT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (median PFS=7.2 versus 6.5 months) in the ITT-WT population.
first line treatment for adults with PD-L1 expressing metastatic NSCLC with no EGFR or ALK genomic tumor aberrations
This approval is based on an interim analysis from the Phase III IMpower110 study, which showed Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months) in people with high PD-L1 expression (TC3/IC3-wild-type [WT]).
Adverse effects associated with the use of Tecentriq in patients with locally advanced or metastatic urothelial carcinoma may include, but are not limited to, the following:
Adverse effects associated with the use of Tecentriq in patients with metastatic non-small cell lung cancer may include, but are not limited to, the following:
Tencentriq also has the potential to cause infection and serious side effects that result from the immune system effect of Tencentriq (known as “immune-mediated side effects”).
Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody. PD-L1 may be expressed on tumor cells and/or tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production. Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody dependent cellular cytotoxicity.
For additional information regarding Tecentriq, please visit https://www.tecentriq.com/