ImmunoGen, Inc. Announces IMGN901 Clinical Data Presented at American Society of Hematology
Published: Dec 10, 2012
"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:
Sixty-four percent of patients had a clinical response (minimal response, MR, or better) to treatment and another 31% had stable disease (SD). Thirty-one percent of these 39 patients had a VGPR (very good partial response) or better, with VGPR being a category established by theInternational Myeloma Working Group to distinguish patients with excellent responses that may have outcomes comparable to patients with complete responses (CR).1 Among the 16 lenalidomide-naïve patients, 14 (88%) had a partial response or better to treatment, with the remaining two patients having stable disease. Among the 23 patients who had received prior lenalidomide (including lenalidomide-refractory patients), 48% had a clinical response to treatment — three (13%) had a VGPR, five (22%) had a PR, and three (13%) had a MR. Another 10 (44%) of these patients had SD. Among the five lenalidomide-refractory patients, one had a VGPR, one had a PR, two had MRs, and one had SD. Among the 1 3 patients with known poor prognostic mutations, 9 (69%) had a clinical response. The other four patients had SD.
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 Europe.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using its TAP technology together with the Company's expertise in monoclonal antibodies and tumor biology. A TAP compound uses a tumor-targeting monoclonal antibody to deliver one of ImmunoGen's purpose-developed 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 andEurope. 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. Revlimid® is a registered trademark of Celgene Corporation.
Velcade® is a registered trademark of Millennium Pharmaceuticals, Inc.
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 June 30, 2012 and other reports filed with theSecurities and Exchange Commission.