This year, James Ford, M.D., and his team at Stanford University Medical Center were proud to open two clinical trials to evaluate new medicines for people with advanced stomach cancer. Both novel therapies target specific genes found in individual tumors. One study will help determine whether these “targeted therapies” may more effectively treat advanced stomach cancer than current standard of care, the other will determine the safety of an investigational medicine that targets a specific gene found in some advanced stomach cancers.
The basis of understanding that supports the studies was provided by GCF-funded research. Stanford investigators have been able to conclude that there are certain genetic changes identified in 10 – 15 percent of individual tumors found in stomach cancer. These are called molecular subtypes and are defined by the type of gene identified in the tumor. These include HER2, also seen in breast cancer and the target of Herceptin™ a commonly used medicine; the recently observed FGFR2 and others. In January, Dr. Ford published an editorial in the Journal of Clinical Oncology that addressed “Molecular Profiling of Gastric Cancer: Toward Personalized Cancer Medicine.” Additional detail about molecular subtypes is available in the editorial.
At Stanford, the first study is a Phase II/III trial that will evaluate trastuzumab emtansine (T-DM1) in people with HER-2 positive stomach cancer. T-DM1 was recently approved for people with HER-2 positive breast cancer, and data in people with breast cancer have been hopeful and positive. HER-2 is slightly different between breast and stomach cancer, but this study will evaluate results in stomach cancer and will compare T-DM1 in people with advanced HER-2 positive stomach cancer with standard taxane therapy. The study is: “A Randomized, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane In Patients With Previously Treated Locally Advanced Or Metastatic Her2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction.”
A second trial “A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients with Advanced Gastric Cancers,” will evaluate another investigational therapy that targets FGFR2. This is an early human clinical trial that may provide a basis for further research.
These two exciting new trials will test that concept of personalized cancer therapy in gastric cancer based on individual tumor characteristics. These are the first of a series of trials being developed around this new concept in cancer therapy.
Please contact Prachi Nandoskar at 650-725-0438 for more information.