Targeted Antibody Payload (TAP) technology did not lie and we knew it and had never been skeptical about the fact that it is a superior technology for cancer treatment. Indeed, ImmunoGen’s (IMGN) lead TAP drug, trastuzumab emtansine for HER2 breast cancer continued to show its superiority over other cancer drugs and other delivery technologies that try to enhance oncology drugs’ efficacy, safety, or both. ImmunoGen’s TAP technology has demonstrated time and time again it improves both safety and efficacy and makes cancer drugs work after the same drugs fail to work when used alone, i.e., not within ImmunoGen’s targeted monoclonal antibody designed armed vehicle.
News at the end of last week announced that Roche has reported updated results from its EMILIA Phase 3 trial showing that patients treated with trastuzumab emtansine – ImmunoGen’s targeted conjugated monoclonal antibody have had a significant improvement in overall survival (OS) compared to those randomized to standard-of-care therapy.
As you know by now, trastuzumab emtansine is a targeted conjugated monoclonal antibody developed based on the targeted antibody payload (TAP) technology created and owned by ImmunoGen (IMGN). The drug is being developed by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group.
Good news announced also informs that Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the US FDA, and that Roche expects to soon submit a Marketing Authorization Application (MAA) to the EMA.
EMILIA, the trials whose results have demonstrated substantial overall survival over standard of care therapy was designed to evaluate trastuzumab emtansine given to patients with metastatic HER2-positive breast cancer who have previously received trastuzumab (Herceptin®) and a taxane (a chemotherapy drug). Patients enrolled were randomized to treatment with trastuzumab emtansine — used alone — or with lapatinib (Tykerb®) plus capecitabine (Xeloda®), standard-of-care in this setting.
The first EMILIA results were reported at the American Society of Clinical Oncology (ASCO) annual meeting in June 2012, and included that trastuzumab emtansine significantly improved PFS compared to standard-of-care therapy and that fewer of the trastuzumab emtansine-treated patients experienced Grade 3 or higher (severe) adverse events. A previous interim analysis of overall survival (OS) demonstrated a trend towards improved OS in the trastuzumab emtansine-treated patients. The updated results reported at the end of the week will be presented at an upcoming medical meeting.
"It's impressive that the overall survival endpoint has already been met — this had been expected to occur well after the submission of the BLA and MAA to the regulatory authorities," commented Daniel Junius, President and CEO. "We developed our TAP technology to achieve more effective, better tolerated anticancer therapies, and are delighted that people treated with trastuzumab emtansine survived significantly longer than those who received a standard therapy."
Mr. Daniel Junius translated the results in lay language.
Roche has Phase 3 trials underway evaluating trastuzumab emtansine both for newly diagnosed and for previously treated metastatic HER2-positive breast cancer. Additionally, it plans to initiate registration trials beginning in 2013 to evaluate the compound for three settings in earlier-stage disease: adjuvant use; neoadjuvant use; and treatment of patients with residual invasive disease following standard neoadjuvant therapy.
Comments: Do we have to add to the obvious results to get the message that the drug is outstanding, that the Tap technology is great and it is a game changer in the treatment of cancer? We do not think any addition is needed following the announcement of these results, especially with regard to the results on OS, which were stunningly quick to pick without the shadow of a doubt.
Important to mention, though, that these results have added validation to the technology, which, in turn, highlights nine products out of ten products in ImmunoGen’s pipeline developed through the TAP technology. Three of these products are wholly owned by ImmunoGen and seven are partnered. In the light of the trial results, this pipeline must represent a treasure in the firm’s pipeline. That’s why we have been puzzled by the market overlooking the value of ImmunoGen’s drugs. Looking at the firm’s market cap, one understand that no value has been not allocated ImmunoGen’s pipeline in spite of the fact that the TAP technology has been validated several times. Puzzling to us also is that some analysts are still downgrading IMGN.
What is even more perplexing to us, however, is that many investors still follow the downgrades, even when they are announced at the wrong time.
We long IMGN