– Marked Clinical Benefit Reported in Most Patients Treated –
WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted antibody-based anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced positive clinical data with the Company’s IMGN901 (lorvotuzumab mertansine) product candidate as featured in an oral presentation (abstract #8013) at the ASCO 2011 Annual Meeting in Chicago. The data are from an ongoing Phase I trial assessing the compound used as part of a combination regimen for the treatment of multiple myeloma. IMGN901 is in development by ImmunoGen for the treatment of CD56-expressing cancers, which include small-cell lung cancer, multiple myeloma, Merkel cell carcinoma, and ovarian cancer.
The data reported today are from a trial designed to assess alternative doses of IMGN901 used in combination with lenalidomide (Revlimid®) and dexamethasone – a standard treatment regimen for multiple myeloma. Escalating doses of IMGN901, given weekly for three weeks in a 4-week cycle, were evaluated in combination with lenalidomide/dexamethasone at their usual doses in patients with relapsed or relapsed/refractory CD56-expressing multiple myeloma.
Among the sixteen patients enrolled at the time of data cutoff for presentation, all had previously been treated with corticosteroids (100%), and most had previously received bortezomib (94%), alkylating agents (75%), thalidomide (69%), lenalidomide (56%), and/or anthracyclines (56%). About two-thirds of the patients had received three or more prior regimens.
The findings reported for the thirteen efficacy-evaluable patients included:
- Over 60% (8/13) had an objective response to treatment: 39% had a very good partial response (VGPR), and 23% had a partial response (PR). VGPR is a category established by the International Myeloma Working Group for partial responses that have clinical outcomes comparable to complete responses.1
- Among the six patients who previously had been treated with lenalidomide, one had a PR, one had a minimal response (MR), and three had stable disease.
- Half of the patients remained on therapy for at least five treatment cycles (approximately 5 months), including all of the patients who had VGPRs.
- Responses, including two of the VGPRs, were seen in patients with chromosomal mutations associated with a poor clinical outcome.
An IMGN901 dose of 75 mg/m2/week (225 mg/m2 or 6.1 mg/kg over 3 weeks in a 4-week cycle) will be taken forward for further investigation in the expansion phase of the trial. At higher doses, peripheral neuropathy was reported with the treatment combination.
“This trial is the first to assess IMGN901 used in combination with standard care, an approach we’re now also using in our small-cell lung cancer trial,” said James O’Leary, Vice President and Chief Medical Officer. “The findings reported today are particularly impressive in light of the other therapies these patients have received. IMGN901 offers not only certain tolerability advantages, but also works by a different mechanism of action than standard multiple myeloma therapies.”
IMGN901 consists of an ImmunoGen CD56-binding antibody with one of the Company’s proprietary cancer-cell killing agents attached using one of ImmunoGen’s engineered linkers. The antibody serves to target the compound specifically to CD56-expressing cancer cells, and the cell-killing agent serves to kill these tumor cells.
This TAP compound is wholly owned by ImmunoGen and is in clinical testing for the treatment of multiple myeloma, small-cell lung cancer, Merkel cell carcinoma, and ovarian cancer. IMGN901 has been granted orphan drug designation for the first three of these cancers in the US and in Europe.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using the Company's expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing agents, and engineered linkers. 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 six TAP compounds in the clinic, with a wealth of clinical data reported with the technology. ImmunoGen’s collaborative partners include Amgen, Bayer HealthCare Pharmaceuticals, Biotest, Genentech (a member of the Roche Group), Novartis, and Sanofi. The most advanced compound using ImmunoGen's TAP technology, trastuzumab emtansine (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.
1Durie et al. Blood. 2006.
Revlimid® is a registered trademark of Celgene Corporation.
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 studies 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.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
The Yates Network
Barbara Yates, 781-258-6153
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