Clinical Trials with Novel Compounds from Germany

Posted by Heinz-Josef Lenz, MD on July 28th, 2009

I wanted to share with you another novel clinical trial using a compound targeting two receptors on tumor cells. Both receptors we know very well: one is HER2, the target for Herceptin, and the other one is EGFR, the target for Erbitux.

One compound targeting both receptors is on the market known as Tykerb® (lapatinib) which is approved for breast cancer patients in combination with Xeloda® (capecitabine).

We are utilizing our pharmacogenomic understanding of these pathways to explore genetic signatures to predict who benefits from these therapies and have initiated a global trial for patients with gastric cancer using Xeloda and Tykerb.

We have also learned that HER2 is not only found in breast cancer but also in gastric cancer, bile duct cancer and potentially ovarian and bladder cancers. We have initiated  a study with Boehringer Ingelheim Germany, together with the Massachusetts General Hospital  using these compounds for patients with different cancers who have overexpression of either EGFR or HER2.

This is another example to select patients for specific therapies more wisely to make sure we increase benefits for our patients. Almost all of our clinical trials are now designed to test tumors first to identify patients whoare  more likely to benefit from targeted therapies by testing to be sure that the target of the drug is present in the tumor.

We have seen very promising data on the HER2-overexpressing gastric and bile duct cancers which seem to have significant benefit from HER2 inhibitors such as Herceptin.

This novel compound is highly effective in inhibiting both important growth factor receptors. This trial is now open for accrual at USC and Mass General.

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