ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that
develops targeted anticancer therapeutics using its Targeted
Antibody Payload (TAP) technology, today announced the presentation
of encouraging clinical data for the Company’s lorvotuzumab
mertansine (IMGN901) targeted anticancer compound at the
35th European Society for Medical Oncology (ESMO) Conference
being held in Milan, Italy, October 8-12, 2010.
Lorvotuzumab mertansine is designed to target and kill cancer
cells that express CD56, a protein. This targeted anticancer
compound is a potential treatment for Merkel cell carcinoma (MCC),
small-cell lung cancer (SCLC), ovarian cancer, multiple myeloma,
and other CD56+ tumors. It is wholly owned by ImmunoGen.
Clinical Data Reported
The data reported today are from an early-stage clinical trial
evaluating lorvotuzumab mertansine in CD56+ solid tumors. During
the dose-escalation phase of the trial, patients with any type of
CD56+ solid tumor were eligible for enrollment. In the ongoing
expansion phase of the trial, enrollment is limited to patients
with MCC, SCLC, or ovarian cancer.
A total of 64 patients with CD56+ solid tumors had been enrolled
at the time of data cut-off for presentation. Among these, 45
patients could be quantitatively assessed for changes in overall
tumor burden. Thirteen (29%) of these 45 patients had a reduction
in tumor volume ranging from 1.3 – 100%, and another
10 patients (22%) had no discernable increase in tumor
burden.
Findings in Merkel Cell Carcinoma
Patients with Merkel cell carcinoma are being enrolled in the
expansion phase of this trial as promising activity has been
reported with lorvotuzumab mertansine for MCC, and the Company is
assessing whether to initiate a pivotal trial with the compound for
this use.
Metastatic MCC is a rare and aggressive neuroendocrine cancer of
the skin. Among patients diagnosed with metastatic MCC, median
survival is less than seven months. There are no approved therapies
for metastatic MCC, and typically the disease progresses rapidly
(within 1 to 2 months) on the therapies currently used.
Thirteen patients with metastatic MCC had been enrolled in the
study at the time of data cut off. Five (38%) of these patients had
notable clinical benefit:
- 1 patient had a complete response (CR)
and has remained disease free for more than 5 years;
- 1 patient had a partial response (PR)
that evolved to a CR, and has been disease free for at least
17 months; and
- 3 patients had clinically relevant
stable disease for this patient population, remaining on
lorvotuzumab mertansine for at least three months.
Findings in Small-Cell Lung Cancer
Twenty-six patients were enrolled with SCLC, which has
commonalities with MCC in biological characteristics, clinical
course and response to treatments. SCLC tumors generally respond to
first-line treatment but then recur. Survival at that stage is
usually less than 6 months.1
While all of the SCLC patients enrolled in this trial had cancer
that had recurred following treatment with other therapies, three
patients had clinically meaningful stable disease and another
patient with refractory disease achieved an unconfirmed PR.
ImmunoGen plans to begin a study later this year to assess
lorvotuzumab mertansine for first-line treatment of SCLC used in
combination with standard care.
“These findings are encouraging in light of the prior treatments
these patients have received and the stage of their disease at the
time of study entry,” commented James O’Leary, MD, Vice President
and Chief Medical Officer. “We believe it’s important to assess
lorvotuzumab mertansine as part of a combination regimen, as cancer
is typically treated with several agents with different mechanisms
of action. The combination trial planned in SCLC and the one
underway in multiple myeloma are expected to be particularly
significant to determining the potential opportunity for this
compound.”
About the Clinical Trial Reported
The patients enrolled at the time of data cut-off for
presentation consisted of 26 patients with SCLC, 16 with
neuroendocrine tumors, 13 with MCC, and 9 patients with other types
of CD56+ solid tumors. The first ovarian patient entered the study
after that time.
In the expansion phase of the trial, lorvotuzumab mertansine is
being administered at a dose of 60 mg/m²/day for three consecutive
days every 21 days.
About Lorvotuzumab Mertansine
Lorvotuzumab mertansine, a TAP compound, consists of a
CD56-binding antibody with ImmunoGen’s potent cancer-cell killing
agent, DM1, attached to it using one of the Company’s engineered
linkers.
Lorvotuzumab mertansine has been granted orphan drug designation
for MCC in the US and Europe. It also has been granted orphan drug
status for SCLC in the US and is in the process of receiving this
designation in Europe.
About MCC, SCLC and Ovarian Cancer
MCC is an aggressive neuroendocrine cancer of the skin that
typically occurs on the head/neck, most often in individuals of
European ancestry. There are approximately 1,900 new cases of MCC
diagnosed in the US each year, with the incidence considered to be
increasing.2 An estimated 28,000 new cases of SCLC are expected to
be diagnosed in the US in 2010, and 22,000 new cases of ovarian
cancer.3, 4 Based on published literature and Company research,
CD56 is expressed on virtually all cases of MCC and SCLC and on
approximately 58% of ovarian cancer tumors.
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
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, 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 Davies A, 2004.
2 Based on incidence data from Agelli M, 2003; Hodgson NC,
2006.
3 American Cancer Society, Cancer Facts & Figures, 2010.
4 American Cancer Society, Guide to small-cell lung cancer,
2010.
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
lorvotuzumab mertansine, including uncertainties around the timing
of clinical trials conducted and their 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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