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Indeed, Roche Filed NDA For T-DM1

Prohost Biotech - Wednesday, July 07, 2010
The First Conjugated Monoclonal Antibody From ImmunoGen’s (IMGN) Technology To Reach That Stage

In Today’s news, Genentech, a member of the Roche Group, announced that the company has, indeed, submitted a Biologics License Application (BLA) to the FDA for trastuzumab-DM1 (T-DM1). The drug’s technology is licensed from ImmunoGen (IMGN). The BLA is for approval of T-DM1 in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies. This submission is based on the results of a Phase 2 study, which showed T-DM1 shrank tumors in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer.

This submission was expected and Prohost mentioned it time and time again, the latest was in Prohost Letter #303 posted on Prohost website on Tuesday when we wrote: “Seeing patients who became resistant to its drug herceptin respond to T-DM1, Roche became excited and motivated to ask the FDA for an early approval of the drug. Patients who had previously received, on average, seven different drugs for their advanced breast cancer had an objective response to treatment with T-DM1. Among the responders were a substantial number of patients with recurrent disease who became resistant to Roche’s blockbuster drug Herceptin. How could anybody believe that ImmunoGen, which has a pipeline of successfully conjugated drugs, be bad?”

The Prohost Letter wrote, “ImmunoGen’s weapon resides in its technological capability that succeeded for the first time in history in designing and developing safe and effective conjugated monoclonal antibody drugs. ImmunoGen’s lead drug Trastuzumab-DM1 (T-DM1) is a monoclonal antibody against HER2 neu breast cancer loaded with the cancer-cell killing agent, DM1. The drug has demonstrated efficacy in patients suffering from her2 neu recurrent resistant breast cancer patients.”

In Genentech/Roche press release, Hal Barron, M.D., executive vice president, Global Development and chief medical officer said: “While we’ve made great strides in treating HER2-positive breast cancer, there is a group of people whose breast cancer will come back after many treatments, leaving them with very limited options. Data from studies have shown that T-DM1 shrank tumors in these people, so we are excited to have submitted this application to the FDA in hopes of offering a potential new medicine to people with this type of breast cancer.”

T-DM1 is an antibody-drug conjugate (ADC), also known as an armed antibody, being studied for advanced HER2-positive breast cancer. T-DM1 attaches trastuzumab and the chemotherapy DM1 together using a stable linker, which is designed to keep T-DM1 in one piece until it reaches specific cancer cells. The antibody (trastuzumab) 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 cells. Then, once T-DM1 is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1.

A Phase 2 study known as TDM4374g, designed to assess single-agent T-DM1 in 110 women with HER2-positive advanced breast cancer whose disease had worsened after receiving at least two prior HER2-targeted treatments Herceptin® (trastuzumab) and lapatinib) in the metastatic setting, as well as an anthracycline, a taxane and capecitabine, demonstrated the following results: 

-- T-DM1 shrank tumors in 33 percent of women with advanced HER2-positive breast cancer that had worsened following treatment with an average of seven prior medicines for metastatic disease.

-- Most side effects were mild (Grade 1-2) and similar to those observed in previous clinical trials of T-DM1.

More trials of T-DM1 are planned for the drug, either alone or in combination with other medicines.  An ongoing Phase 3 trial, known as EMILIA, is comparing T-DM1 to lapatinib in combination with capecitabine in people with advanced HER2-positive breast cancer whose disease has worsened after receiving initial treatment. Also, a planned Phase 3 study, MARIANNE, will compare both T-DM1 alone and T-DM1 in combination with pertuzumab to Herceptin in combination with a taxane chemotherapy in people with advanced HER2-positive breast cancer who have not been previously treated for advanced disease.

Genentech has opened a T-DM1 Patient Access Study in the United States to provide a specific group of people with advanced HER2-positive breast cancer access to T-DM1 while Genentech seeks U.S. approval.

Genentech licenses technology for T-DM1 from ImmunoGen (IMGN).

For the complete press release click:
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