Hope for patients with urothelial carcinoma: Atezolizumab (Tecentriq) approved

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May 18, 2016 –  Over the last two years, biologics  targeting the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells), notably Nivolumab (Opdivo) and Pembrolizumab (Keytruda), have come to the clinic for the treatment of a selection of oncologic indications. By blocking the PD-1/PD-L1 pathway, these medicines may help the patients immune system to fight cancer cells, and are part of the evolving story about the relationship between the patient’s immune system and its interaction with cancer cells as a new mode of action principle in cancer therapy.
Antibody-based inhibitors of the PD-1/PD-L1 pathway

Antibody-based inhibitors of the PD-1/PD-L1 pathway

The latest addition to this broader and growing class of PD-1/PD-L1 inhibitor therapeutics, Atezolizumab (Tecentriq) has just been approved by the American Food & Drug Administration (FDA) for the treatment of the most common type of bladder cancer, called urothelial carcinoma. In contrast to Nivolumab (Opdivo) and Pembrolizumab (Keytruda) which target the PD-1 receptor,  Tecentriq targets the PD-L1 ligand and is actually the first of its kind approved by FDA.

 Atezolizumab (Tecentriq) has been approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment. Urothelial carcinoma is the most common type of bladder cancer and occurs in the urinary tract system, involving the bladder and related organs. The National Cancer Institute (NCI) estimates 76,960 new cases of bladder cancer and 16,390 deaths from the disease in 2016 in the US alone.

The safety and efficacy of Atezolizumab (Tecentriq) were studied in 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 participants 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 of participants experienced a tumor response (compared to 9.5 percent of participants who were classified as “negative” for PD-L1 expression).

While patients who received Atezolizumab (Tecentriq) experienced a tumor response across the study, the greater effect in those who were classified as “positive” for PD-L1 expression suggests that the level of PD-L1 expression in tumor-infiltrating immune cells may help identify patients who are more likely to respond to treatment with Atezolizumab (Tecentriq). Therefore, today the FDA also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients’ tumor-infiltrating immune cells and help physicians determine which patients may benefit most from treatment with Atezolizumab (Tecentriq).

The most common side effects of treatment with Atezolizumab (Tecentriq) were fatigue, decreased appetite, nausea, urinary tract infection, fever (pyrexia) and constipation. Atezolizumab (Tecentriq) also has the potential to cause infection and serious side effects that result from the immune system effect of Atezolizumab (Tecentriq) (known as “immune-mediated side effects”). These severe immune-mediated side effects involve healthy organs, including the lung, colon and endocrine system.

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About the Author
thassodotcom Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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