The New T-DM1 Breast Cancer Drug, An Oncologist's Reaction - Dr ...

In this video, Dr. David A. Margileth discusses the new T-DM1 drug that was released during the American Society of Clinical Oncology meeting in Chicago. He discusses how the drug works and what it means for the medical community?s ability to treat certain types of breast cancer.

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David A. Margileth, M.D.:?At last week?s American Society of Clinical Oncology meeting in Chicago, which is by far the largest cancer meeting in the world, probably the most exciting talk was the talk about a drug called T-DM1, which is a drug that will be used for breast cancer that over-expresses a gene called the HER2/neu gene.

The HER2/neu gene is a growth regulatory gene that all of our normal cells have two copies of.? In about 20% of breast cancer patients, those cancer cells may have 100s or even 1000s of copies of that gene and this is referred to as an over-expression of the HER2/neu gene.

In the past, this was a particularly aggressive form of breast cancer and had a high risk of metastasis.? Probably the most important advance in breast cancer in the last 5 or 10 years has been the development of a drug called Herceptin.? Herceptin is a monoclonal antibody directed against the HER2 positive breast cancer cell and has resulted in a vast improvement in the prognosis of HER2 positive breast cancer.? One of the more exciting developments have been the development of other anti-HER2 drugs and at this point in time, that is probably the most exciting part of breast cancer research.? A drug called Tykerb was developed many years ago, which is a very good drug in patients who have progressed after utilizing Herceptin.

The newest drug, is a drug called T-DM1, which is a antibody drug conjugate, meaning that a drug has been attached to an antibody and in this case the antibody is Herceptin the same drug we have been using all along, and the company that developed T-DM1 found a way to attached a drug called Emtansine, which is an older actually fairly toxic drug that was discarded back in a 70s and they found a way to attach this drug or molecules of this drug to the antibody Herceptin.

The way this works is that the Herceptin, as it does as a single agent, finds the HER2-positive breast cancer cell, attaches to it and takes the Emtansine chemotherapy molecular intracellularly and thereby kills the HER2-positive breast cancer cell.? The trial presented at ESCO last week, the Emilia trial, was a trial of metastatic breast cancer, patients that were HER2-positive that had actually progressed on a Taxol or a Taxane plus the drug Herceptin.? They were about a thousand patients that were randomized to either receive the more standard approach, which would be Tykerb, the second line anti-HER2 drug plus a drug called Xeloda, which is a pill and they compare that to the single agent T-DM1, which is Herceptin plus this chemotherapy molecule.? What they found was in this pre-treated group with metastatic breast cancer that had already had Herceptin, that the T-DM1 worked much better than the Tykerb plus Xeloda, which was heretofore the best treatment for Herceptin refractory patients.

In this pre-treated group, the progression free survival was extended by at least three months and it would appear with further followup that the overall survival will be improved compared to the Tykerb plus Xeloda.

The other exciting part is that T-DM1 has very little toxicity, no hair loss, no nausea and vomiting, and the most common toxicity they saw was a clinically insignificant decrease in the platelet count, so that the hope is that this T-DM1 will be moved probably in the front line of metastatic disease and then ultimately replace Herceptin in the adjuvant setting.? This is a very exciting development.? This is a drug that has very little toxicity and if it is better than Herceptin, would be a huge advance in the treatment of HER2-positive breast cancer.

Dr. David A. Margileth practices medical oncology at St. Joesph Hospital in Orange, CA specializing in oncology, hematology, and internal medicine (board certified). His selected area of interest is breast cancer. Dr. Margileth graduated from Baylor College of Medicine in 1971 and has since spent time treating patients at the National Cancer Institute and Methodist Hospital in Houston, TX.

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