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By E. Kevin Hrusovsky, PerkinElmer Inc. As the complexity and volume of data continue to rise, bioinformatics is emerging as one of the cornerstones of personalized medicine, from enabling discovery and development of novel treatments and diagnostics to facilitating collection, analysis and interpretation of data that ultimately helps an individual patient. SPECIAL REPORT PART 1: ‘Good enough’ is no longer good enough By Randall Willis, ddn Features Editor Aiming beyond the standard of care in oncology By Randall Willis, ddn Features Editor Are we really making things better for cancer patients? High-profile oncology partnership By Jim Cirigliano, ddn Contributing Editor Araxes Pharma and Janssen Biotech ink oncology drug development deal Natural neighbors By Kelsey Kaustinen, ddn Features Editor OSU, Biosortia link up to identify natural products for potential cancer treatments  |
 New Genentech breast cancer drug shows late stage trial success
04-02-2012
SHARING OPTIONS:
SOUTH SAN FRANCISCO, Calif.—Genentech, a member of
the Roche Group, recently announced top-line results of EMILIA, the first
randomized Phase III study of trastuzumab emtansine (T-DM1), showing that
people who received trastuzumab emtansine lived significantly longer without
their disease getting worse (progression-free survival) compared to those who
received lapatinib plus Xeloda (capecitabine).
Trastuzumab emtansine is an investigational
medicine known as an antibody-drug conjugate (ADC). It is comprised of the
antibody trastuzumab and the chemotherapy DM1 attached together using a stable
linker. It is designed to target and inhibit HER2 signaling and deliver the
chemotherapy directly inside HER2-positive cancer cells. According to
Genenetch, trastuzumab emtansine “reinforces Roche’s personalized healthcare
approach of developing targeted medicines to fight cancer.”
Based on these findings, Genentech plans to submit
a Biologics License Application for trastuzumab emtansine to the U.S. Food and
Drug Administration this year for HER2-positive mBC. In addition, Roche plans
to submit a Marketing Authorization Application to the European Medicines Agency
this year for the same indication. Genentech licenses technology for
trastuzumab emtansine under an agreement with ImmunoGen Inc.
As Luke Timmerman noted at Xconomy.com, “Even though Genentech is responsible for
development, and will keep the vast majority of product revenues for itself,
today’s result is an important moment for ImmunoGen. The company stands to
collect a ‘mid-single digit’ percentage royalty on worldwide sales from T-DM1,
because of its contribution to help link the antibody to the toxin. ImmunoGen
has no products of its own on the market, and the approval of T-DM1 would
provide a significant percentage from a potential multi-billion
dollar seller.”
The co-primary efficacy endpoints of the study are
progression-free survival (as assessed by an independent review committee) and overall
survival. Other study endpoints include safety profile, one-year and two-year
survival rates, progression-free survival as assessed by investigator, overall
response rate, duration of response and quality of life.
In addition to EMILIA, there are two ongoing Phase
III studies of trastuzumab emtansine. MARIANNE is comparing three different
regimens (trastuzumab emtansine alone, trastuzumab emtansine plus pertuzumab,
and Herceptin plus a taxane chemotherapy) in people with HER2-positive metastatic
breast cancer who have not been previously treated for their metastatic
disease. TH3RESA is comparing trastuzumab emtansine to physician's choice of
treatment in people with HER2-positive metastatic breast cancer who have
already received both Herceptin and lapatinib.
According to Genentech, “Building on the results
of trastuzumab emtansine studies to date, Roche/Genentech have approximately 30
ADCs in the pipeline.” Code: E03301201 Back |
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