By Business Wire, September 28, 2013, 07:30:00 AM EDT
- Roche's Kadcyla found to significantly extend duration of
progression-free survival in patients with advanced HER2-positive
breast cancer in second large randomized trial.
- Kadcyla comprises Roche's trastuzumab antibody and ImmunoGen's ADC
technology; it has been approved for marketing in several countries
including the US.
WALTHAM, Mass.--(BUSINESS WIRE)--
ImmunoGen, Inc. (Nasdaq:IMGN), a biotechnology company that develops
novel anticancer therapeutics using its antibody-drug conjugate (ADC)
technology, announced the results from Roche's TH3RESA Phase III trial
being presented today at the European Cancer Congress (ECC) in Amsterdam
(abstract #LBA15). The findings were accepted as late-breaking data and
also included in the Congress's official press program.
The TH3RESA study assessed Kadcyla (ado-trastuzumab emtansine) for the
treatment of advanced HER2-positive breast cancer that had progressed
despite prior treatment with at least two HER2-targeted medicines. At a
minimum, patients must have received Herceptin® (trastuzumab), Tykerb®
(lapatinib), and a taxane. The trial included approximately 600 patients
who were randomized, on a two-to-one basis, to receive either Kadcyla or
a treatment of their physician's choice. Eighty percent of the patients
treated with physician's choice received a regimen containing Herceptin
plus a second agent.
Kadcyla was found to significantly extend duration of progression-free
survival (PFS) compared to treatment with physician's choice (median 6.2
months vs. 3.3 months, respectively) and reduced the risk of disease
progression or death by 47 percent (HR=0.528; p<0.0001). In the planned
interim analysis, overall survival (OS) favored Kadcyla, but the data
are not yet mature. PFS and OS are co-primary endpoints of the trial. No
new safety signals were observed with Kadcyla.
Based on the earlier EMILIA Phase III trial, Kadcyla is approved for
marketing in several countries, including the US, Japan, Switzerland,
Canada, and Australia, with additional approvals expected. EMILIA
assessed Kadcyla for the treatment of patients with HER2-positive
metastatic breast cancer who had received prior treatment with Herceptin
and a taxane chemotherapy. To be eligible for inclusion in the TH3RESA
trial, patients would also need to have previously received treatment
"The TH3RESA trial provides further support of improved progression-free
survival with Kadcyla in patients with advanced HER2-positive breast
cancer," commented Dan Junius, President and CEO. "We are delighted that
our technology is helping make such an important difference to patients."
Kadcyla consists of Roche's trastuzumab antibody and ImmunoGen's DM1
cytotoxic agent. The DM1 is attached to the antibody using one of
ImmunoGen's linkers. Roche has global development and commercialization
rights for Kadcyla; ImmunoGen is entitled to receive specified milestone
payments and royalties on product sales.
Roche is conducting a number of studies assessing Kadcyla for potential
additional uses. These include for the first-line treatment of
HER2-positive metastatic breast cancer, for early stage HER2-positive
breast cancer and for advanced HER2-positive gastric cancer.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's
ADC technology uses a tumor-targeting engineered antibody to deliver one
of ImmunoGen's highly potent cancer-cell killing agents specifically to
tumor cells. The most advanced compound with ImmunoGen's ADC technology
is Roche's Kadcyla, which is marketed in the US by Genentech and is also
gaining approvals internationally. ImmunoGen has four wholly owned
clinical-stage product candidates, with additional compounds in the
clinic through its partnerships with Amgen, Bayer HealthCare, Biotest
and Sanofi. More information about the Company can be found at www.immunogen.com.
Kadcyla®, Herceptin®, and Tykerb® are
registered trademarks of their respective owners.
Source: ImmunoGen, Inc.