T-DM1:EMILIA Breast Cancer Study Results Indicate Improved Safety and Efficacy
The Emilia study, a phase III trial of T-DM1 in comparison to Capecitabine plus lapatinib satiated the high expectations of the ASCO crowd. Kimberly L. Blackwell, MD, Duke Cancer Institute presented the favorable results. Watch the video where Dr. Blackwell discusses the results.
T-DM1 as most people know by now is a monoclonal antibody linked to a toxin which is delivered into the cell where the toxin destroys the cell. The T here is trastuzumab/Herceptin and the DM1 is the potent maytansine derivative. The molecule is a powerful missile with trastuzumab having ability to recognize tumor cells and deliver the toxin linked to it into the tumor cell, to bring about lysis of cell by DM1.
Let me detail out the study in brief prior to discussing the results and the conclusions…
- Patients previously treated with taxane and trastuzumab experiencing progression during treatment was eligible.
- Also eligible were those who had recurrent disease within a span of 6 months of adjuvant therapy.
- 991 patients were enrolled of which only 978 took part.
- Patients were either administered T-DM1/Capecitabine+lapatinib.
Let us come to the results of the much celebrated trial…
- Median progression-free survival was 9.6 months for the T-DM1 group when compared to that of 6.4 months in the Capecitabine+lapatinib group.
- Subgroup analysis also favored T-DM1 excepting in patients aged 65 years and above.
- T-DM1 was safer than the combination of Capecitabine/lapatinib.
- Median time to symptom progression was 7.1 months for the T-DM1 arm while it was 4.6 months for the Capecitabine/lapatinib arm.
- Incidence of adverse events was lower for T-DM1.
- There was no increase in cardiac toxicity.
Now to the Conclusions
Dr. Blackwell concludes that T-DM1 is safer and more efficient than Capecitabine/lapatinib and should be considered as an important therapeutic option for treatment of HER2 positive breast cancer.
The overall survival data are awaited and will be obtained only by 2014. However, the excellent results have prompted Roche/Genentech, the developers of T-DM1 to apply for regulatory FDA approval of the drug.
Definitely, the drug is a new technology and very impressive, however it remains to be seen whether 3 months of progression free survival would be enough to get the requisite approval.
Video credit: http://www.youtube.com/watch?v=N-szqnrRdfU