Roche’s Drug T-DM1 for Breast Cancer – Phase II Results are “Stunning”

In advance of the oncology conference of the ESMO (European Society for Medical Oncology) in Milan on Monday, Severin Schwan, Chief Executive Officer of Roche Holding AG announced his opinion that the data from the Phase II trial for T-DM1 was “stunning.” T-DM1is in clinical trials for breast cancer. It is the first of a new kind of “armed antibody” that can carry a cell-killing payload into cancer cells. The drug is being developed with partner ImmunoGen. T-DM1’s results were better than than that of Herceptin plus Taxotere. In addition, clinically adverse side effects were lower.
Herceptin, also a Roche drug, and currently has sales of about $5 billion annually.
More details will be released this week.

T-DM1 has advanced to Phase III testing.
For further details about this press information from Reuters please click here.

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A Different Approach to Clinical Trials for Breast Cancer – Personalized Treatments

A recent Wall Street Journal article entitled “A New Rx for Medicine” discussed an entirely new approach to clinical trials for potential breast cancer drugs. The trial, called I-Spy 2 is a joint study between Dr. Laura Esserman, Director of the Breast Care Center at the University of California, San Francisco, and Dr. Don Berry at the MD Anderson Hospital in Houston. I-Spy 2 attempts to match experimental drugs from three companies (currently testing 5 drugs from Abbot Laboratories, Amgen Inc, and Pfizer) with the patients who might have the best response to them, as determined by the molecular makeup of the patient’s tumor. It tests multiple drugs at once with the aim to get the most effective ones into later stage trials more quickly. Conventional treatment is also combined with the drugs being tested.

A few important and differentiating points about the trial are:
1. All tumors are tested for biomarkers or molecular traits.
2. The study focuses on women with aggressive breast cancers that have not spread to other organs.
3. MRI identification and evaluation of the tumor is performed periodically to check the size.
4. Chemotherapy is given before surgery (six months of treatment with chemotherapy)
5. Standard chemotherapy is used as well as the experimental agents.
6. All data and results are evaluated during the treatment as compared to conventional trials where the results may be blind until the study reaches completion.

“The goal is to pair drug and biomarker signatures and graduate them into a small phase III trial that has gotten rid of the subset of patients that don’t benefit” stated Dr. Berry.

To read the full Wall Street Journal Article please click here.
http://online.wsj.com/article/SB10001424052748703882404575520190576846812.html

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