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Bone and Cancer

Clinical Trials

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:

triple negative breast 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 paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA approved test. 

Tecentriq is supplied as an injection for intravenous administration. The recommended dose is 840 mg administered as an intravenous infusion over 60 minutes, followed by 100 mg/m2 paclitaxel protein-bound. For each 28 day cycle, Tecentriq is administered on days 1 and 15, and paclitaxel protein-bound is administered on days 1, 8, and 15 until disease progression or unacceptable toxicity. Tecentriq and paclitaxel protein-bound may be discontinued for toxicity independently of each other. If the first infusion is tolerated, all subsequent infusions of Tecentriq may be delivered over 30 minutes. See also the prescribing information for paclitaxel protein-bound prior to initiation.

Clinical Results

FDA Approval

This indication is approved under accelerated approval based on progression free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMpassion130 was a multicenter, international, double-blinded, placebo-controlled, randomized trial that included 902 unresectable locally advanced or metastatic triple-negative breast cancer patients who had not received prior chemotherapy for metastatic disease. Patients were randomized (1:1) to receive either Tecentriq (840 mg) or placebo intravenous infusions on Days 1 and 15 of every 28-day cycle, plus paclitaxel protein-bound (100 mg/m2) administered via intravenous infusion on Days 1, 8 and 15 of every 28-day cycle. Patients received treatment until radiographic disease progression per RECIST v1.1, or unacceptable toxicity. Results demonstrated that the combination of Tecentriq plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]), as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in the intention-to treat and PD-L1 positive population. The treatment was most effective in the patient population with PD-L1 expression ≥ 1%: the median PFS for the Tecentriq plus chemo arm was 7.4 months versus 4.8 months for the placebo plus chemo arm. 

Side Effects

Adverse effects associated with the use of Tecentriq in combination with paclitaxel protein-bound for triple negative breast cancer may include, but are not limited to, the following:

alopecia

peripheral neuropathies

fatigue

nausea

diarrhea

anemia

constipation

cough

headache

neutropenia

vomiting

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 triple negative breast cancer, please visit https://www.tecentriq-hcp.com/

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