ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced the presentation of new clinical data with the Company's targeted anticancer compound, IMGN901. The data were from a Phase I clinical study assessing IMGN901 used in combination with lenalidomide (Revlimid®) and dexamethasone to treat patients with CD56-expressing relapsed or relapsed/refractory multiple myeloma. The data were reported in an oral presentation (abstract #728) at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta, Georgia.
"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 the International Myeloma Working Group to distinguish patients with excellent responses that may have outcomes comparable to patients with complete responses (CR).
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 13 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.