ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, announced the results from Roche’s TH3RESA Phase III trial being presented today at the European Cancer Congress (ECC) in Amsterdam (abstract #LBA15). The findings were accepted as late-breaking data and also included in the Congress’s official press program.
The TH3RESA study assessed Kadcyla (ado-trastuzumab emtansine) for the treatment of advanced HER2-positive breast cancer that had progressed despite prior treatment with at least two HER2-targeted medicines. At a minimum, patients must have received Herceptin® (trastuzumab), Tykerb® (lapatinib), and a taxane. The trial included approximately 600 patients who were randomized, on a two-to-one basis, to receive either Kadcyla or a treatment of their physician’s choice. Eighty percent of the patients treated with physician’s choice received a regimen containing Herceptin plus a second agent.
Kadcyla was found to significantly extend duration of progression-free survival (PFS) compared to treatment with physician’s choice (median 6.2 months vs. 3.3 months, respectively) and reduced the risk of disease progression or death by 47 percent (HR=0.528; p<0.0001). In the planned interim analysis, overall survival (OS) favored Kadcyla, but the data are not yet mature. PFS and OS are co-primary endpoints of the trial. No new safety signals were observed with Kadcyla.
Based on the earlier EMILIA Phase III trial, Kadcyla is approved for marketing in several countries, including the US, Japan, Switzerland, Canada, and Australia, with additional approvals expected. EMILIA assessed Kadcyla for the treatment of patients with HER2-positive metastatic breast cancer who had received prior treatment with Herceptin and a taxane chemotherapy. To be eligible for inclusion in the TH3RESA trial, patients would also need to have previously received treatment with Tykerb.
“The TH3RESA trial provides further support of improved progression-free survival with Kadcyla in patients with advanced HER2-positive breast cancer,” commented Dan Junius, President and CEO. “We are delighted that our technology is helping make such an important difference to patients.”