ImmunoGen, Inc. Announces Encouraging Clinical Data with Its IMGN901 Compound in the Treatment of Multiple Myeloma
December 06 2009 - 6:00PM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that
develops targeted anticancer therapeutics, today reported
encouraging clinical data with its IMGN901 product candidate in the
treatment of relapsed and relapsed/refractory multiple myeloma
(MM), including prolonged benefit in patients whose disease had
progressed on multiple prior treatment regimens. These findings
were reported at the American Society of Hematology (ASH)
51th Annual Meeting and Exposition being held in New Orleans,
MA.
IMGN901 is an investigational agent designed to kill cancer
cells that express CD56, a protein. It consists of a CD56-binding
antibody with a potent cancer-cell killing agent, DM1, attached to
it using an engineered linker. IMGN901 is in Phase I testing for
the treatment of CD56-expressing solid tumors and multiple myeloma.
It is wholly-owned by ImmunoGen.
In the trial reported today, new cohorts of patients received
increasingly greater amounts of IMGN901 – used as a single agent –
until the maximum tolerated dose was established. All of the
patients had CD56-expressing MM that had progressed on multiple
therapies, and most had previously been treated with at least six
chemotherapy regimens.
“What was particularly impressive was the duration of benefit
seen with IMGN901 in a number of these heavily pre-treated
patients,” commented Asher Chanan-Khan, MD, of the Roswell
Park Cancer Institute. “IMGN901 demonstrated encouraging activity
as a single agent in a disease often treated with combination
therapy, and the tolerability findings to date support evaluating
it used together with other active agents.”
Among the twenty-six patients treated with IMGN901 at any dose
level:
- One patient had a partial
response (PR) while receiving IMGN901. This patient has continued
on treatment for more than a year.
- Three patients had a minimal
response (MR) while receiving IMGN901, and two of these patients
remained on treatment for at least 45 weeks. The third patient
withdrew from the study due to a broken leg while continuing to
show disease improvement.
- Eleven patients had stable
disease (SD), with eight of these patients remaining on treatment
for at least 12 weeks at the time of data cut-off for presentation.
These include four patients who have received IMGN901 for at least
24 weeks and two other patients still undergoing treatment.
- The overall clinical benefit
rate (objective responses plus sustained stable disease) was
46%.
Ten patients remained on IMGN901 longer than on regimens
received earlier in the course of their disease, and eight of these
patients were on IMGN901 longer than on their last regimen with
approved therapies. Typically in the treatment of cancer, patients
have their best treatment responses early in the course of their
disease and respond less well to later therapies.
IMGN901 was found to be generally well tolerated and was not
associated with significant myelosuppression or other side effects
that would limit its ability to be administered in combination with
other active agents. The most common side effects were
mild-to-moderate headache, fatigue and neuropathy. Grade 3 fatigue
was reported in two patients and was the only grade 3 side effect
reported in more than one patient; no more severe (grade 4 or 5)
side effects were associated with use of the agent. The maximum
tolerated dose was established to be 112 mg/m2/week.
“This trial – Study 003 – has provided us with important
information on the safety of IMGN901 when used alone to treat
multiple myeloma that has progressed on numerous prior therapies,”
noted James O’Leary, MD, Vice President and Chief Medical Officer
of ImmunoGen. “The expansion phase of this trial, which is now
underway, provides for patients with less heavily pretreated
multiple myeloma to receive IMGN901 at the maximum tolerated dose,
enabling us to better assess its activity when used as a single
agent.”
Dr. O’Leary continued, “Multiple myeloma is often treated with a
combination of therapies with different mechanisms of action. Thus,
we feel it’s important to also assess IMGN901 as part of a
multi-agent regimen. The profile of IMGN901 suggests that it’s
particularly well suited to use in combination, as it works by a
novel mechanism and has not been associated with side effects that
would limit its ability to be used with other agents. We expect
patient dosing in our Study 005 combination trial to begin
shortly.”
About the Presentation
The poster, “Phase I Study of IMGN901, Used as Monotherapy, in
Patients with Heavily Pre-Treated CD56-Positive Multiple Myeloma –
A Preliminary Safety and Efficacy Analysis” is being presented at
ASH between 6:00 – 8:00 pm (CT). Dr. Chanan-Khan is the lead
investigator in the study.
About Study 003
This Phase I trial evaluates IMGN901 in patients with CD56+
multiple myeloma that has progressed on prior treatments (relapsed
disease) and may no longer respond to these agents (refractory
disease). In Study 003, IMGN901 is administered weekly for two
consecutive weeks every three weeks (one treatment cycle). During
the dose-escalation portion of the trial, no limit was placed on
the number of prior therapies a patient may have received. In the
expansion phase now underway, patients must have received at least
one but no more than three prior treatment regimens to be eligible
for enrollment. In this leg of the trial, progression-free survival
and overall survival data will be captured as well as objective
response information.
Other IMGN901 Studies
Study 005 is a Phase I trial designed to evaluate IMGN901 in
CD56+ multiple myeloma when used in combination with lenalidomide
(Revlimid®) and dexamethasone. It is expected to start in late
2009. Study 002 evaluates IMGN901 in the treatment of CD56+ solid
tumors, which include small-cell lung cancer, Merkel cell carcinoma
and ovarian cancers. Patient enrollment is underway in the
expansion portion of this trial.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
its expertise in cancer biology, monoclonal antibodies and the
creation and attachment of potent cancer-cell killing agents. The
Company’s Targeted Antibody Payload (TAP) technology uses
antibodies to deliver one of ImmunoGen’s proprietary cancer-cell
killing agents specifically to tumors. In addition to the Company’s
product pipeline, compounds utilizing the TAP technology are in
clinical testing through ImmunoGen’s collaborations with Genentech
(a wholly-owned member of the Roche Group), sanofi-aventis, Biogen
Idec and Biotest. The most advanced compound, trastuzumab-DM1
(T-DM1), is in Phase III testing being conducted by Genentech
and Roche. Other ImmunoGen collaborative partners include Bayer
HealthCare and Amgen. More information about ImmunoGen can be found
at www.immunogen.com.
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, 2009 and other reports filed with the Securities and
Exchange Commission.
Revlimid® is a registered trademark of Celgene Corporation.
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