Genentech announces positive results from Phase II study of T-DM1

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Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from a Phase II study of trastuzumab-DM1 (T-DM1). As assessed by independent review, T-DM1 shrank the tumors (also known as objective response) in 33 percent of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment. Women in the study had already received an average of seven drugs for metastatic disease, including chemotherapy, trastuzumab and lapatinib, prior to receiving T-DM1. No new or unexpected safety signals were observed. Results were presented today at the 32nd Annual San Antonio Breast Cancer Symposium (Abstract #710).

“Despite major advances in HER2-positive breast cancer, the disease may still progress after multiple treatments, to the point where there are no approved HER2-targeted medicines,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “Results from this study are promising for women who need new treatment options, and we will discuss next steps of the T-DM1 development program with the FDA.”

“These results are significant because they demonstrate that T-DM1 was effective at shrinking tumors in women whose cancer had progressed following prior treatment with standard therapies for HER2-positive breast cancer,” said Ian Krop, M.D., Ph.D., a medical oncologist at Dana-Farber Cancer Institute, and lead investigator on the study.

In this single-arm study, 45 percent of women experienced a clinical benefit (defined as a complete or partial tumor response, or stable disease, maintained for at least six months), as assessed by independent review. Adverse events were similar to those observed in previous clinical trials of T-DM1. The most common severe adverse events included thrombocytopenia (a low level of platelets in the blood, 5.5 percent) and back pain (3.6 percent), and the most common adverse events were fatigue (59.1 percent) and nausea (37.3 percent). No severe (Grade 3 or higher) cardiac-specific side effects were observed. One patient with pre-existing, non-alcoholic fatty liver disease died with hepatic failure.


  1. susan rothbaum susan rothbaum United States says:

    It seems every where you turn you hear of breast cancer awareness, which I think is both great in raising awareness and sad that there are so many people out there that worry on a daily basis about fighting to stay alive. I am however a little angered because there is little awareness for the MEN that have BREAST CANCER. Yes, there are men out there that have breast cancer. It is just as deadly for them as it is for a woman. The only problem is NOONE realizes that men also can get breast cancer. I have someone very special to me that fights every day to live and everywhere you turn you hear people always says WOMENS breast cancer. I think that its about time to raise awareness that MEN also can suffer this disease. Lets give praise and support to the men that deserve it. I know that I give the man in my life support every day and will continue to do so.  

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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