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• Roche has announced lead Phase III trial with trastuzumab emtansine has met progression-free survival endpoint
• Plans to apply for marketing approval of trastuzumab emtansine in US and Europe
• Study data being submitted for presentation at major medical meeting
WALTHAM, MA, March 30, 2012 – ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology, today announced that Roche has announced positive topline results from its trastuzumab emtansine (T-DM1) EMILIA Phase III trial. Trastuzumab emtansine consists of ImmunoGen’s potent cancer-killing agent, DM1, attached to the HER2-targeting antibody, trastuzumab, and is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group.
Roche announced today that the EMILIA patients who were randomized to treatment with trastuzumab emtansine had a significantly longer duration of progression-free survival (PFS) than those randomized to treatment with the control therapy, lapatinib (Tykerb®) plus capecitabine (Xeloda®). EMILIA is the most advanced trastuzumab emtansine Phase III study, and evaluates the compound for the treatment of HER2-positive metastatic breast cancer (mBC) in patients who have previously received treatment with trastuzumab (Herceptin®) and a taxane.
Roche said that, based on these findings, it plans to apply for marketing approval of trastuzumab emtansine for HER2-positive mBC in the US (through Genentech) and in Europe. Roche also noted that the safety profile of trastuzumab emtansine in the EMILIA trial was consistent with previous studies and that final results for overall survival (OS) are not yet mature. PFS and overall survival are co-primary efficacy endpoints of EMILIA.
“The topline results reported today underscore the significance of trastuzumab emtansine and its potential to help patients,” commented Daniel Junius, President and CEO. “We’re delighted with these results and with Roche’s plans to submit trastuzumab emtansine for marketing approval. We look forward to seeing the detailed study data at an upcoming medical meeting.”
Trastuzumab emtansine is in Phase III testing for treatment of HER2-positive mBC in multiple clinical settings in the EMILIA, MARIANNE, and TH3RESA trials, and in Phase II testing for adjuvant/neoadjuvant use for earlier-stage disease.
Conference Call Information
ImmunoGen is holding a conference call today at 8:00 am ET to discuss this release and also the Company’s advancement of its wholly owned IMGN901 product candidate into Phase II testing. To access the live call by phone, dial 913-312-0982. Passcode is 8250254. The call also may be accessed through the Investor Information section of the Company’s website, http://www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through April 6, 2012.
About ImmunoGen’s TAP Technology
ImmunoGen developed its TAP technology to achieve more effective, better tolerated anticancer drugs. A TAP compound consists of a manufactured antibody that binds specifically to a target found on tumor cells with one of the Company’s highly potent cancer-killing agents attached as a payload. The antibody serves to target the payload specifically to the cancer cells, and the payload serves to kill the cancer cells. In the case of some compounds that use ImmunoGen’s TAP technology (trastuzumab emtansine and ImmunoGen’s IMGN529 compound), the antibody component also has meaningful anticancer activity.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using the Company’s expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing agents and engineered linkers. The Company’s TAP technology uses monoclonal antibodies to deliver one of ImmunoGen’s proprietary cancer-killing agents specifically to tumor cells. There are now numerous TAP compounds in clinical development with a wealth of clinical data reported. ImmunoGen’s collaborative partners include Amgen, Bayer HealthCare, Biotest, Lilly, Novartis, Roche, and Sanofi. The most advanced compound using ImmunoGen’s TAP technology, trastuzumab emtansine (T-DM1), is in Phase III testing through the Company’s collaboration with Genentech, a member of the Roche Group. More information about ImmunoGen can be found at http://www.immunogen.com.
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 trastuzumab emtansine (T-DM1), including risks related to clinical studies and regulatory submissions, 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, 2011 and other reports filed with the Securities and Exchange Commission.
Tykerb® is a registered trademark of GlaxoSmithKline plc.
Xeloda® is a registered trademark of Roche.
Herceptin® is a registered trademark of Genentech, a member of the Roche Group.
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Posted: March 2012
— EMILIA Study Showed Trastuzumab Emtansine Significantly Extended the Time People with HER2-Positive Metastatic Breast Cancer Lived without Their Disease Getting Worse —
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Mar 30, 2012 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced topline results of EMILIA, the first randomized Phase III study of trastuzumab emtansine (T-DM1). The study enrolled people with HER2-positive metastatic breast cancer (mBC) who had previously received treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. The study showed people who received trastuzumab emtansine lived significantly longer without their disease getting worse (progression-free survival, or PFS) compared to those who received lapatinib plus Xeloda® (capecitabine). Final results for overall survival (OS), a co-primary efficacy endpoint of EMILIA, are not yet mature. The safety profile of trastuzumab emtansine was consistent with that seen in previous studies. These data will be submitted for presentation at an upcoming medical meeting.
Trastuzumab emtansine is an investigational medicine known as an antibody-drug conjugate (ADC). It is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells. Trastuzumab emtansine reinforces Roche’s personalized healthcare approach of developing targeted medicines to fight cancer.
“Trastuzumab emtansine represents a new approach for the treatment of people with HER2-positive breast cancer that comes from our decades of research on the HER pathway,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are excited about the EMILIA results because trastuzumab emtansine is our first antibody-drug conjugate and it may help people who still need more treatment options for this aggressive disease. We will work to submit these data to regulatory authorities as quickly as possible.”
Based on these findings, Genentech plans to submit a Biologics License Application for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA) this year for HER2-positive mBC. In addition, Roche plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA) this year for the same indication.
About the EMILIA Study
EMILIA (TDM4370g/BO21977) is an international, Phase III, randomized, open-label study comparing trastuzumab emtansine alone to lapatinib in combination with Xeloda in 991 people with HER2-positive mBC whose disease progressed after initial treatment with Herceptin and a taxane chemotherapy.
Participants in the trastuzumab emtansine arm received:
Trastuzumab emtansine 3.6 mg/kg every three weeks
Participants in the lapatinib and Xeloda arm received:
Lapatinib 1250 mg dailyXeloda 2000 mg/m2, days 1 – 14, every three weeks
The co-primary efficacy endpoints of the study are PFS (as assessed by an independent review committee) and OS. Other study endpoints include safety profile, one-year and two-year survival rates, PFS as assessed by investigator, overall response rate, duration of response and quality of life.
About Trastuzumab Emtansine
Trastuzumab emtansine is an ADC being studied in HER2-positive cancers. Trastuzumab emtansine is designed to inhibit HER2 signaling and deliver the chemotherapy agent DM1 directly inside HER2-positive cancer cells. Trastuzumab emtansine binds to the HER2-positive cancer cells, and is thought to block out-of-control signals that make the cancer grow while also calling on the body’s immune system to attack the cancer cells. Once trastuzumab emtansine is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1.
In addition to EMILIA, there are two ongoing Phase III studies of trastuzumab emtansine:
MARIANNE is comparing three different regimens (trastuzumab emtansine alone, trastuzumab emtansine plus pertuzumab, and Herceptin plus a taxane chemotherapy) in people with HER2-positive mBC who have not been previously treated for their metastatic disease.TH3RESA is comparing trastuzumab emtansine to physician’s choice of treatment in people with HER2-positive mBC who have already received both Herceptin and lapatinib.
Genentech, a member of the Roche Group, licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc.
Building on the results of trastuzumab emtansine studies to date, Roche/Genentech have approximately 30 ADCs in the pipeline.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 229,000 people will be diagnosed with breast cancer, and 40,000 will die from the disease in 2012. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of the tumor cells. This is known as “HER2 positivity” and affects approximately 25 percent of people with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Contact: Genentech
Media:
Krysta Pellegrino, 650-467-6800
or
Advocacy:
Sonali Padhi, 650-467-0842
or
Investor:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
Posted: March 2012
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