ImmunoGen, Inc., a biopharmaceutical company that develops anticancer therapeutics using its Targeted Antibody Payload (TAP) technology, announced the presentation of the first clinical data for trastuzumab-DM1 (T-DM1) used in combination with pertuzumab for first-line treatment of HER2+ metastatic breast cancer (mBC). These data were presented at the 33rd Annual San Antonio Breast Cancer Symposium.
T-DM1 consists of the HER2-targeting antibody, trastuzumab, with ImmunoGen’s cancer cell-killing agent attached using the Company’s linker and method of attachment. T-DM1 is in global development by Roche under a licensing agreement between ImmunoGen and Genentech, a member of the Roche Group. Pertuzumab is a HER2 Dimerization Inhibitor in development by Roche.
The data reported are from a Phase 1b/2 clinical trial conducted by Roche to assess T-DM1 used in combination with pertuzumab to treat HER2+ mBC. The study enrolled 21 patients who had not received prior systemic anticancer therapy for metastatic disease. Among these patients, 57.1% had a confirmed objective response to treatment with T-DM1 plus pertuzumab.
All of these patients had received anticancer agents prior to their development of metastatic disease (e.g., as adjuvant therapy). Eighty-six percent (86%) of these patients had received Herceptin (trastuzumab), 71% had received a taxane, and 62% had received an anthracycline before being diagnosed with metastatic disease.
In October, preliminary data were reported for T-DM1 used alone as first-line treatment for HER2+ mBC.1 Those data were from a 137-patient, randomized Phase II trial. At the time of the cut-off date for the data included in that presentation, 47.8% of patients receiving T-DM1 as a single agent had a confirmed objective response, as compared to 41.4% of patients treated with Herceptin used in combination with a taxane. It was noted in the oral presentation that the study groups included patients with unconfirmed responses at the time of the data cut-off. Updated data from this trial are expected in 2Q2011.
“The data that have been reported with T-DM1 for the first-line treatment of HER2+ metastatic breast cancer are highly encouraging, both with T-DM1 as a single agent and used in combination with pertuzumab,” commented Daniel Junius, President and Chief Executive Officer. “Our TAP technology is designed to produce effective anticancer agents that also are well tolerated, supporting their evaluation in earlier stages of disease and/or as part of combination regimens.”
In addition to the Phase 2 trial reported, a Phase 3 trial, MARIANNE, is underway that assesses T-DM1 for first-line treatment of HER2+ mBC. In MARIANNE, T-DM1 given as a single agent and T-DM1 given in combination with pertuzumab are both compared to Herceptin used in combination with a taxane.
Date: December 13, 2010
Source: ImmunoGen, Inc.