Emilia Study: New Drug Prolongs Life for Stage IV Survivors

PJ Hamel Health Guide
  • The potential to live longer with metastatic breast cancer is every stage IV survivor’s hope. And now a new drug shows not just potential, but concrete results: women who take this drug, dubbed a “smart bomb,” are living longer.


    UPDATE: On Feb. 22, 2013, the FDA approved the new drug cited below, Kadcyla (T-DM1), for use by women whose cancer has failed to respond to Herceptin and Taxol/Taxotere. It should become available almost immediately.


    We’ve all heard the stories, usually delivered with a studied look of concern and hope by the morning news team at the local TV affiliate:

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    “A new breast cancer drug is saving lives. We’ll be back after the break with more on this stunning development.”


    And we wait impatiently through the car and furniture and supermarket ads for more on this potential life-saver, until finally the news folks come back and reveal… well, usually not much.


    A drug we already know about. Some positive results from a tiny study involving lab mice, results that are years and years (and many pitfalls) away from ever turning into viable treatment.


    And we sigh and change the channel.


    But yesterday (June 2), at the annual meeting in Chicago of ASCO (American Society of Clinical Oncologists), results of a new drug trial could indeed be termed a “stunning development.”   


    Researchers report that women with stage IV HER2+ cancer taking the new drug, “T-DM1,” are living longer than those being treated with the usual protocol: Herceptin and Taxol (or Taxotere), followed by Tykerb or Xeloda.


    How much longer? Well, results are just barely in, so it’s impossible to say with certainty. But the study’s authors, including lead investigator Dr. Kimberly Blackwell of the Duke [University] Cancer Institute, project at least 1 year. And statisticians who’ve seen the data from “Emilia” (the study’s name) agree with that assessment.


    Another 12 months of being alive? Of seeing your son graduate from high school, or a first grandchild born, or your daughter married?


    Most stage IV survivors would call this possibility “stunning” news indeed.


    Here are the facts: Genentech, part of the mammoth pharmaceuticals company Roche, has spent a decade developing this new, more effective version of its multi-billion dollar drug Herceptin, the standard of care for HER2+ patients for the past 10 years.


    Herceptin, a targeted therapy (or immune targeted therapy), consists of manufactured antibodies that “target” specific properties of cancer cells: their production of protein, their use of enzymes, or their ability to form new blood vessels to support growth. They leave healthy cells alone, which is a plus.


    T-DM1 takes Herceptin a step further by pairing it with a powerful cancer-killing toxin, creating a new type of drug: an antibody-drug conjugate (ADC). Thus, T-DM1 combines Herceptin’s ablility to target and latch onto cancer cells (while leaving healthy cells alone) with a deadly cancer drug. Herceptin delivers a “smart bomb” that cancer cells absorb, causing their death.


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    And more cancer cells dying, more quickly, translates to longer life for survivors.


    Nearly as important, the women in Emilia receiving T-DM1 were much less likely to experience some of the tough side effects seen in those taking Xeloda and Tykerb: diarrhea, vomiting, and rashes. As any of us who’ve been through cancer treatment know, quality of life, not simply length, is vitally important. And side effects can lower quality of life substantially.


    T-DM1 isn’t without its drawbacks. The T-DM1 group experienced lowered platelet counts (though it only rarely translated to increased bleeding); and some in the group showed signs of potential liver damage – though none developed liver disease.


    Still, the drug showed enough potential that Genentech will submit an application later this year for FDA approval; and the company is hoping T-DM1 will be on the market as early as next year. UPDATE: The drug was approved by the FDA on Feb. 22, 2013, and was slated to come onto the market almost immediately.


    Just as important for researchers is the potential of this new class of drugs (ADCs), which has been envisioned for 20 years or more, and is finally being realized. Scientists say other ADCs using this same “smart bomb” technology could be used to treat cancers of all kinds – not just breast cancer.


    In the meantime, stage IV HER2+ breast cancer survivors will be some of the first patients with access to this significant advance in cancer treatment.


    For once, the news really is stunning.




    Pollack, A. (2012, June 3). In study, drug delays worsening of breast cancer, with fewer side effects. Retrieved from http://www.nytimes.com/2012/06/03/health/research/in-study-drug-delays-worsening-of-breast-cancer-with-fewer-side-effects.html?_r=1


    Timmerman, L. (2012, June 3). Genentech, Immunogen ‘smart bomb’ for breast cancer blazes new trail. Retrieved from http://www.xconomy.com/san-francisco/2012/06/03/genentech-immunogen-smart-bomb-for-breast-cancer-blazes-new-trail/


Published On: June 03, 2012