A Phase III study showed that a combination of Novartis’s drug Femara and GlaxoSmithKline’s drug Tykerb can significantly delay progression of breast cancer in some patients, said researchers on Thursday.
Encouraging doctors to use Femara, chemically known as letrozole with Tykerb, or lapatinib, means millions of dollars in potential extra sales for Glaxo, but it will depend largely on how many patients benefit.
A study involving 1,286 patients found a sub-set of women with aggressive HER2-positive metastatic breast cancer – tumors that overproduce a protein known as HER2 – gained considerably when taking both drugs together.
On average, 219 patients given both drugs went 8.2 months before their disease progressed, while patients taking Femara alone had a median progression-free survival (PFS) of about 3 months.
Tykerb is a new drug targeting the protein HER2 and a protein called EFGR, while Femara is a well known hormone-based drug for women with hormone receptor-positive cancer.
When the drug combination was given to patients regardless of HER2 status, the benefitw were minimal, with PFS extended by a month to a median 11.9 months.
The clinical results were promising for women with hormone receptor – and HER2-positive tumors. Glaxo presented the findings at the San Antonio Breast Cancer Symposium in Texas this week.
“In the near future, we plan to present the findings to regulators,” said Paolo Paoletti, senior vice president of oncology research and development at GSK.
It is unclear whether there is adequate evidence to persuade oncologists to use both drugs across a wider group, regardless of HER2 status.
In 2007, Tykerb was approved in the U.S. for use with Roche’s Xeloda to treat advanced, metastatic breast cancer.
In another recent study, researchers found a new experimental technique called molecular breast imaging (also referred to as MBI) was three times more effective than traditional mammography at detecting breast cancer tumors in women who have dense breast tissue, researchers said. #