Benefit seen in both lenalidomide-naïve and lenalidomide-refractory multiple myeloma
"The level and duration of the responses to the study regimen confirm the activity seen with IMGN901 in earlier trials — where it was evaluated as single-agent therapy — and support the further development of IMGN901 as a treatment for CD56-expressing cancers," commented James O'Leary, MD, Vice President and Chief Medical Officer.
The trial was designed to assess IMGN901, given weekly for three weeks in a 4-week cycle, used in combination with lenalidomide and dexamethasone. As reported previously, a dose of 75 mg/m2/week was established for IMGN901 in the dose-finding phase of the trial for evaluation in its expansion phase. Patients received lenalidomide and dexamethasone at standard doses (25 mg daily for 21 days in a 4-week cycle and 40 mg weekly for four weeks, respectively).
A total of 44 patients with relapsed or relapsed/refractory multiple myeloma were enrolled in the trial. Most of the patients had previously received bortezomib (Velcade®) (91%) and/or lenalidomide (59%), and many had received prior thalidomide (46%). Many patients also had received prior alkylating agents (64%) and/or anthracyclines (41%). About half of the patients had prior stem cell transplant.
The response findings reported for the 39 efficacy-evaluable patients included:
Of particular note, median time-to-progression was 7.7 months with the study regimen (IMGN901 at 75 mg/m2).
The safety profile was consistent with the previously observed profiles of the drugs. The most common adverse events associated with the study regimen (occurring in > 25% patients) consisted of Grade 1/2 peripheral neuropathy, fatigue, neutropenia, thrombocytopenia, nausea and diarrhea. Of note, the majority of patients entering the trial had Grade 1 peripheral neuropathy from prior therapy.
IMGN901, also known as lorvotuzumab mertansine, is wholly owned by ImmunoGen and consists of the Company's DM1 cancer-cell killing agent attached to its lorvotuzumab CD56-binding antibody using one of the Company's engineered linkers.
Encouraging findings have been reported with IMGN901 in initial
evaluations for the treatment of multiple myeloma, small-cell lung
cancer (SCLC), and Merkel cell carcinoma (MCC). IMGN901 is in Phase II
testing, in the NORTH trial, for front-line treatment of SCLC. It has
been granted orphan drug designation for multiple myeloma, SCLC, and MCC
in the US and
Revlimid® is a registered trademark of Celgene Corporation.
Velcade® is a registered trademark of
1Durie et al. Blood. 2006
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
Executive Director, Investor Relations and Corporate Communications
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