– Data Presented at the 13th World
Conference on Lung Cancer Demonstrate Favorable Tolerability and
Promising Activity for SCLC and Related Tumors –
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 initial efficacy, safety and tolerability clinical data with
its IMGN901 product candidate in the treatment of small-cell lung cancer
(SCLC). In two early-stage clinical trials that enrolled patients whose
SCLC had recurred following treatment with standard chemotherapies,
IMGN901 administration achieved notable tumor shrinkage and/or sustained
stable disease. The compound also demonstrated encouraging activity
against other CD56-expressing (CD56+) solid tumors. These clinical data
are being presented at the 13th World Conference on Lung
Cancer taking place in San Francisco, CA, from July 31 to Aug. 4, 2009.
IMGN901 was created by ImmunoGen to kill tumors that express the CD56
protein targeted by the compound. It consists of a potent cancer-cell
killing agent, DM1, attached to a CD56-targeting antibody, huN901, using
an engineered linker. IMGN901 currently is in early clinical testing and
is a potential treatment for SCLC, Merkel cell carcinomas, ovarian
cancers, multiple myeloma, and other CD56+ cancers.
“We are encouraged by the initial efficacy and safety profile of IMGN901
in SCLC and Merkel cell carcinoma, especially as these cancers have
proven highly challenging to treat,” stated Professor Penella J. Woll,
MD, PhD, Weston Park Hospital, UK. “The data thus far indicate that
IMGN901 offers potential for use in a number of indications, including
several types of CD56-expressing solid tumors.”
The findings being presented at the 13th World Conference on
Lung Cancer by Professor Woll come from the two IMGN901 trials that
included SCLC patients. Study 001 (enrollment has closed) was open to
patients with any type of CD56+ solid tumor, including SCLC, during its
dose-escalation Phase I leg. In its Phase II leg, enrollment was limited
to patients with SCLC or other CD56+ small-cell carcinoma. In this
trial, IMGN901 was administered weekly for four weeks every six weeks.
Study 002 (enrollment is ongoing) is a dose-escalation trial evaluating
IMGN901 in patients with CD56+ solid tumors, including SCLC, when
administered daily for three consecutive days every 21 days. In both
trials, the SCLC must have recurred following previous treatment with
standard therapies for a patient to qualify for enrollment.
SCLC Clinical Data Reported
To date, 68 SCLC patients have been treated with IMGN901. All of these
patients had received prior chemotherapy, and most had received at least
two previous regimens. Among the findings were:
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The estimated clinical benefit rate was 25%, consisting of patients
with an objective response and/or sustained stable disease
(non-progression for at least 77 days).
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An objective response was reported in a patient whose SCLC had
recurred within four months of treatment with cisplatin, etoposide,
and topotecan plus radiation therapy. This patient had a partial
response (PR) after his first IMGN901 treatment cycle and reached a
91% reduction in tumor size by the end of his third cycle. His disease
progressed after his fourth cycle – 24 weeks after he first received
IMGN901.
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Another SCLC patient had an objective response (an unconfirmed PR) and
no evidence of disease progression for more than 8 weeks.