This time, we’ll start from the end…
Results of the study
First of all, it is important to note that the research goals were not achieved in the entire study population and were to show that the drug, “Tecentriq”, increases the effectiveness of the treatment when added to treatment with a drug called “Kadcyla” which acts against HER2compared to Kadcyla alone.
However, when analyzing the data, it was found that adding Tecentriq to Kadcyla, increases survival and extends the time to disease progression among PD-L1-positive patients:
94% of patients in the combination arm lived a year later from the start of treatment compared to 88% of patients in the single arm.
The duration of time to disease progression of the two-drug treatment was 8.5 months compared to the 4.1 month with the single drug, when the chance of recurrence during the treatment was reduced by 40% in the combination arm.
The study is called KATE2
KATE2 is a global study that recruited positive HER2 positive patients with advanced or metastatic breast cancer. The patients who were suitable for the study were those whose disease progressed after treatment with Herceptin and Taxanes.
Patients were randomly assigned in a 2: 1 ratio to receive Kadcyla with Tecentric or with Placebo.
Safety of Tecentric Combined with Kadcyla
The combination of Tecentriq with Kadcyla was rather well tolerated. In the immunotherapy arm there was a higher rate of infusion reactions, which is a common adverse event of monoclonal antibody infusions. There were also higher rates of thrombocytopenia and transaminitis, which are known adverse events of Kadcyla.
Immune-related adverse events could potentially be attributed primarily to Tecentriq. The three most common immune-related adverse events were rash, hypothyroidism and pancreatitis.
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