WALTHAM, Mass. -- (Business Wire)
ImmunoGen,
Inc. (NASDAQ: IMGN), a biotechnology company that develops novel
anticancer therapeutics using its antibody-drug conjugate (ADC)
technology, today reported that Roche has announced top-line results of
its Phase III MARIANNE study.
The study evaluated three HER2-targeted regimens – Kadcyla®
(ado-trastuzumab emtansine) plus Perjeta® (pertuzumab), Kadcyla alone,
and Herceptin® (trastuzumab) plus taxane chemotherapy – in people with
previously untreated HER2-positive metastatic breast cancer (mBC).
Kadcyla utilizes ImmunoGen’s ADC technology and is already approved to
treat patients with HER2-positive mBC who previously received
trastuzumab and a taxane.
Roche has reported the MARIANNE study showed the three regimens helped
people live without their disease worsening (PFS) for a similar amount
of time, meeting its non-inferiority endpoint as assessed by an
Independent Review Committee. However, neither Kadcyla-containing
treatment arm significantly improved PFS compared to Herceptin and
chemotherapy. Adverse events observed in the two experimental arms of
the study were generally consistent with those seen in previous studies
of Kadcyla and/or Perjeta.
“While we are disappointed by this unexpected outcome, we are pleased
that so many patients can benefit from Kadcyla with its already approved
use and also with the breadth of Roche’s Kadcyla clinical development
program,” commented Daniel Junius, President and CEO. “Roche has a
number of other trials underway with Kadcyla, and in 2015 expects data
and – if positive – regulatory submission from its GATSBY study in
gastric cancer.”
Roche expects data from the MARIANNE study to be reported at an upcoming
medical meeting, and to discuss the findings with appropriate regulatory
authorities.
This event has no impact on ImmunoGen’s financial guidance for the
Company’s 2015 fiscal year, or on the approved use of Kadcyla.
About Roche’s MARIANNE Study
This Phase III study (NCT01120184; BO22589) is an international,
randomized, multicenter, three-arm study involving 1,095 people with
HER2-positive mBC. People with mBC at diagnosis and those whose disease
had worsened following either neoadjuvant or adjuvant treatment were
eligible for enrollment in the study.
The primary endpoint of the MARIANNE study is PFS as assessed by an
independent review facility. Secondary endpoints include overall
survival, response rate, and the incidence of adverse events.
Differences in these endpoints were assessed in each of the
Kadcyla-containing treatment arms compared to the Herceptin plus
chemotherapy arm, and also between the two Kadcyla-containing arms.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s
ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen
cell-killing agent specifically to cancer cells; the Company has also
developed antibodies with anticancer activity of their own. The first
product with ImmunoGen’s ADC technology is Roche’s Kadcyla®. ImmunoGen
has three wholly owned product candidates in clinical testing with
additional compounds in clinical testing through the Company’s
partnerships with Amgen, Bayer HealthCare, Biotest and Sanofi. More
information about ImmunoGen can be found at www.immunogen.com.
Herceptin®, Kadcyla®, and Perjeta® are
registered trademarks of Genentech, a member of the Roche Group.
This press release includes forward-looking statements. For these
statements, ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities Litigation
Reform Act of 1995. It should be noted that there are risks and
uncertainties related to the development of novel anticancer products,
including Kadcyla, including risks related to clinical studies and
regulatory interactions, their timings and results. A review of these
risks can be found in ImmunoGen’s Annual Report on Form 10-K for the
fiscal year ended June 30, 2014 and other reports filed with the
Securities and Exchange Commission.
Contacts:
For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
info@immunogen.com
or
For
Media:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
Source: ImmunoGen, Inc.
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