BCAC is excited to see new results from a clinical trial which show that women diagnosed with HER2-positive metastatic breast cancer lived longer when they received the experimental medicine T-DM1 (trastuzumab emtansine).
The results come out of the phase III EMILIA study which involves more than 990 women diagnosed with metastatic or advanced HER2–positive breast cancer who had stopped responding to standard treatments.
Half of the women in the study received the new T-DM1 drug, which is a combination of Herceptin and a chemotherapy drug. The Herceptin targets the HER2-positive cancer cells and is able to deliver the chemotherapy agent directly to these cells. The other half of the women in the study received a combination of Tykerb® (lapatinib) and Xeloda® (capecitabine).
The company which makes T-DM1, Genentech, recently announced that the latest results show the drug improved overall survival in women who received it compared with the women who received Tykerb® and Xeloda®. Those women would now be offered the opportunity to receive T-DM1.
The head of Genentech’s Global Product Development and its chief medical officer, Dr. Hal Barron says, “We are extremely pleased to announce that people treated with trastuzumab emtansine survived significantly longer than those who received a standard option for this aggressive advanced breast cancer.
"We believe that antibody-drug conjugates have the potential to change the future treatment of cancer, and we look forward to working with regulatory authorities in the hope of bringing another potential treatment option to people with HER2-positive metastatic breast cancer."
BCAC chair, Libby Burgess, says T-DM1 is an exciting development.
“It’s fantastic to see the success of targeted drugs that ‘smash’ cancer cells and leave other healthy cells intact. I’m looking forward to seeing the results of another international clinical trial that is now testing the effects of T-DM1 in women with early breast cancer.”
Libby says New Zealand women in Waikato and Auckland with metastatic HER2 positive breast cancer can participate in a clinical trial looking at T-DM1 – the Marianne Trial. See BCAC’s clinical trials page for more details about this and other clinical trials open to New Zealand women.
In the meantime, Genentech plans to release the detailed figures from the latest phase of the trial at an upcoming medical meeting. It will also seek regulatory approval to market the drug.
Previous results from the EMILIA study found that progression-free survival – the time women lived without the cancer growing – was longer for women treated with T-DM1 (9.6 months) compared to women treated with Tykerb and Xeloda (6.4 months).
Severe side effects can be common with many cancer treatments and about 41 per cent of women who got T-DM1 had severe side effects compared to 57 per cent of women who got the Tykerb-Xeloda combination.