ImmunoGen, Inc. Announces Initiation of Randomized Clinical Trial Evaluating IMGN901 for First-Line Treatment of Small-Cell L...
November 30 2010 - 5:30AM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a
biotechnology company that develops antibody-based anticancer
products using its Targeted Antibody Payload (TAP) technology,
today announced the initiation of a randomized Phase I/II clinical
trial to evaluate its proprietary product candidate, IMGN901
(lorvotuzumab mertansine), for first-line treatment of small-cell
lung cancer (SCLC) in patients with extensive disease.
“We believe IMGN901 has the potential to be an important
treatment for SCLC, particularly as part of a combination regimen,”
commented James O’Leary, MD, Vice President and Chief Medical
Officer. “IMGN901 has been found to be well tolerated and to
demonstrate evidence of activity when used as a single agent to
treat this highly aggressive cancer. The tolerability profile of
IMGN901 supports evaluating it in combination with other active
agents, and – in preclinical testing – it has shown highly
compelling activity used together with these same therapies.”
This multi-national trial will evaluate IMGN901 used together
with carboplatin plus etoposide (C/E) – standard care for
first-line treatment of SCLC – versus C/E alone. In the
dose-escalation Phase I portion of the trial, increasing doses of
IMGN901 will be administered with C/E to establish the maximum
tolerated dose of the study compound with C/E. In the Phase II
portion, patients will be randomized to receive C/E plus IMGN901
(60 patients) or C/E alone (30 patients).
IMGN901 will be administered weekly for two weeks in a
three-week cycle, and C/E will be dosed on the standard three-week
schedule. Patients can receive up to six cycles of C/E, consistent
with established usage, but those randomized to also receive
IMGN901 will be allowed to remain on the study drug alone as long
as they continue to benefit from it.
The primary endpoint of this trial is progression-free survival
(PFS). Secondary endpoints include PFS at 6 months, overall
survival at 12 months, time to progression, overall survival, and
overall response rate.
About IMGN901
IMGN901 consists of ImmunoGen’s CD56-targeting antibody with the
Company’s proprietary cancer-cell killing agent, DM1, attached
using one of ImmunoGen’s engineered linkers. This TAP compound is
wholly owned by ImmunoGen and is in clinical testing for the
treatment of several CD56+ malignancies – SCLC, Merkel cell
carcinoma, ovarian cancer and multiple myeloma. IMGN901 has been
granted orphan drug designation for SCLC and for MCC in the US and
in Europe.
About Small-Cell Lung Cancer (SCLC)
It is expected that approximately 31,000 new cases of SCLC will
be diagnosed in the US this year.1 SCLC tends to spread more
rapidly than non-small cell lung cancer and has usually spread by
the time of diagnosis. As a result, SCLC is usually treated with
chemotherapy rather than with surgery. Once patients relapse after
first-line chemotherapy, survival is usually less than 6
months.2
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
the Company's expertise in tumor biology, monoclonal antibodies and
potent cancer-cell killing agents. The Company's TAP technology
uses monoclonal antibodies to deliver one of ImmunoGen's
proprietary cancer-cell killing agents specifically to tumor cells.
There are currently seven TAP compounds in the clinic, with a
wealth of clinical data reported with the technology. ImmunoGen’s
collaborative partners include Amgen, Bayer Schering Pharma, Biogen
Idec, Biotest, Genentech (a member of the Roche Group), Novartis,
and sanofi-aventis. The most advanced compound using ImmunoGen's
TAP technology, trastuzumab-DM1 (T-DM1), is in Phase III testing
through the Company's collaboration with Genentech. More
information about ImmunoGen can be found at www.immunogen.com.
1 ACS Cancer Facts & Figures, 2010.2 Davies, A., 2004.
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 IMGN901, including risks
related to uncertainties around clinical trials conducted and 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, 2010 and other reports filed with the Securities and
Exchange Commission.
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