About “Kadcyla”, Ado-trastuzumab emtansine and HER2-Amplified Advanced Salivary Gland Cancer, SGC –
Ado-trastuzumab emtansine, more commonly known as T-DM1 and sold under the trade name “Kadcyla”, is a HER2 targeted antibody-drug conjugate consisting of the humanized monoclonal antibody “Herceptin”, trastuzumab, covalently linked to the cytotoxic agent DM1.
KADCYLA is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer).
HER2 gene amplification identified through molecular testing occurs in 8% of patients with SGC and approximately 30% of patients with the aggressive salivary duct carcinoma.
Kadcyla demonstrated robust activity in HER2-amplified salivary gland cancer (SGC) within a phase II trial yet further investigation in this disease is required: Among the 10 patients with SGC treated with Kadcyla, nine obtained an “objective response”, six of which were “complete responses”. The 10 participants with SGC had already received a median of two prior systemic therapy regimens.
“Objective response” is defined as the percentage of patients whose cancer shrinks after treatment. Usually 30-50% size decrease of a measurable lesion.
“Complete response” is defined as the complete disappearance of a cancerous lesion after treatment.
How was Kadcyla given?
All patients received treatment with Kadcyla 3.6 mg/kg of intravenous every 3 weeks which is the standard dosing regimen.
About Salivary Gland Cancer, SGC –
SGCs are rare tumors accounting for only 0.8% of all cancers with no approved therapy for metastatic disease. HER2 amplification occurs in 8% among all SGC histologies and 25-33% of the aggressive salivary duct carcinoma (SDC) histologic subtype. Diseases arising in the salivary ducts harbor a particularly poor prognosis given its tendency to metastasize and the fact that no approved therapies exist for metastatic SGC.
The researchers hypothesized that Kadcyla, a HER2 targeted antibody drug conjugate, may be clinically active in these patients.
The plan now is to enroll 14 additional patients as a result of the impressive outcomes of the treatment,
The researchers feel that Kadcyla will still be approved based on this small sample size, as has occurred with other agents in rare diseases.
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