The trial was evaluating temsirolimus in combination with Femara, Novartis’ currently approved breast cancer therapy. The study compared the combination of the drugs versus Femara alone.
This decision was based upon the recommendation of an independent data monitoring committee (IDMC), which advised that continuation of the trial was unlikely to achieve the targeted level of efficacy for the combination therapy compared to Femara alone.
The committee concluded that the risk/benefit ratio for treatment of metastatic breast cancer did not favor continuation and recommended that the trial be discontinued.
“While not the anticipated outcome, it is unfortunately not unusual for cancer drugs to work in some tumor types and not others, or even work in only some specific subpopulations of cancer patients,” said Dr Gary Stiles, executive vice president and chief medical officer, Wyeth Pharmaceuticals.
While the phase III trial for women with hormone-receptor positive metastatic breast cancer involved an oral formulation of temsirolimus, two other phase III clinical trials studying temsirolimus in renal cell carcinoma and mantle cell lymphoma using an intravenous formulation are continuing. After a recent review of the data, the IDMC for the renal cancer study indicated that study should continue as planned.