ImmunoGen, Inc. Attains Patient Enrollment Milestone in IMGN901 NORTH Trial
February 12 2013 - 5:30AM
Business Wire
ImmunoGen, Inc. (NASDAQ: IMGN), a
biotechnology company that develops targeted anticancer
therapeutics, today announced that it has completed patient
enrollment in the first stage of its NORTH two-stage Phase II
trial. The NORTH trial is assessing the Company’s IMGN901 product
candidate for first-line treatment of extensive disease small-cell
lung cancer (SCLC). Attaining this milestone enables the findings
from the planned interim analysis of PFS at 6 months to be
available in 2H2013.
The NORTH trial is designed to assess whether IMGN901 provides a
clinically meaningful benefit when used in conjunction with a
standard-of-care for this cancer, etoposide plus carboplatin (E/C).
Patients with newly diagnosed extensive disease SCLC enrolled in
the trial are randomized, two-to-one, to treatment either with
IMGN901 plus E/C or with E/C alone.
While the NORTH trial is designed to include a total of 120
patients, its two-stage design specifies that an analysis of PFS at
six months is to be performed with the first 39 evaluable patients
randomized to the IMGN901 plus E/C treatment arm. Patient
enrollment of this cohort of patients – and the corresponding 20
patients in the E/C alone arm – has now been completed. These
patients will now be followed for the interim analysis while
patient enrollment continues.
“Achieving timely enrollment of patients with small-cell lung
cancer is known to be challenging, and we believe our attainment of
this milestone on schedule speaks to both the clinical need for new
therapies for SCLC and our increasing strength as a development
company,” commented James O’Leary, MD, Vice President and Chief
Medical Officer. “When available, we intend to use the findings
from the interim analysis to make decisions related to the
development of IMGN901. We also plan to submit them for
presentation at a medical conference.”
ImmunoGen’s NORTH Trial
The 120-patient NORTH trial is designed to evaluate the efficacy
and safety of IMGN901 for first-line treatment of extensive disease
SCLC. All patients enrolled are provided with up to six cycles of
E/C, standard-of-care for this cancer. Two-thirds of the patients
enrolled are randomized to also receive IMGN901. These patients can
elect to remain on IMGN901, as monotherapy, after completion of the
E/C cycles if benefiting from treatment.
The primary endpoint of the NORTH 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 was developed by ImmunoGen to target and kill
CD56-positive cancer cells. CD56 is expressed on virtually all
cases of SCLC. It is also expressed on a variety of other cancers
including Merkel cell carcinoma and many cases of multiple
myeloma.
IMGN901 employs the Company’s Targeted Antibody Payload (TAP)
technology, which uses a CD56-binding antibody to target one of
ImmunoGen’s highly potent cell-killing agents to CD56-positive
cancer cells.
About SCLC
It is estimated that approximately 29,400 new cases of SCLC will
be diagnosed in the United States this year.1 Approximately
two-thirds of patients have extensive disease at the time of
diagnosis, as SCLC tends to spread broadly through the body quite
early in its course.2 As a result, SCLC is usually treated with
chemotherapy rather than with surgery.3 Median PFS for extensive
disease SCLC is approximately 5.5 months, while median overall
survival averages 9-11 months.3,4
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The
Company’s TAP technology uses a tumor-targeting monoclonal antibody
to deliver one of ImmunoGen's highly potent cancer-killing agents
specifically to tumor cells. Ten TAP compounds are now in clinical
testing, of which three are wholly owned by the Company. Marketing
applications for trastuzumab emtansine (T-DM1), the most advanced
compound using ImmunoGen's TAP technology, are under review in the
US, Europe and Japan. Roche is developing this compound globally
under an agreement between ImmunoGen and Genentech, a member of the
Roche Group. More information about ImmunoGen can be found at
www.immunogen.com.
1 American Cancer Society, Cancer Facts & Figures 2012.2
American Cancer Society, Lung Cancer (Small Cell) 2012.3National
Comprehensive Cancer Network (NCCN) Guidelines.4Foster, NR, Qi, Y,
Krook, JE, et al. (2009). J Clin Oncol, 27(15s).
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 preclinical and clinical studies, 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, 2012 and
other reports filed with the Securities and Exchange
Commission.
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