Roche Suffers A Double Blow As Breast Cancer, Alzheimer’s Drug Studies Fail; Pulls Plug On ALZ's Drug Development
December 19, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Despite positive news with its acquisition of Austria-based Dutalys yesterday, Switzerland-based Roche got hammered by two poor clinical trials outcomes today. One trial of Kadcyla for breast cancer failed to prove benefit, and another for an Alzheimer’s medication was ended because it failed to prove effectiveness.
In the breast cancer trial, the Phase III MARIANNE study, three HER2-targeted regimens were evaluated for HER2-positive breast cancer. The regimens were Kadcyla plus Perjeta, Kadcyla alone, and Herceptin plus taxane chemotherapy. All three approaches were found to help people live without the disease getting worse. However, the two approaches include Kadcyla did not show significant improvement compared to Herceptin and chemotherapy.
“Over the past 30 years, we have made significant progress in treating one of the most aggressive forms of advanced breast cancer with medicines that extend patients’ lives across the course of their disease. In this study, we had hoped to show improvement in progression-free survival without the use of traditional chemotherapy in the first line treatment of patients with advanced HER2-positive breast cancer,” said Sandra Horning, Roche’s chief medical officer and head of global product development in a statement. “While MARIANNE didn’t achieve this result, we will continue to study these medicines, as well as investigational treatments for other types of breast cancer, with the goal of improving outcomes for patients.”
In the Alzheimer’s trial, dubbed the Scarlet RoAD, an investigational anti-amyloid drug, gantenerumab, was being investigated in a Phase III study in prodromal (pre-dementia) Alzheimer’s disease. The trial was ended after disappointing results.
“We are disappointed with these study results because people with early stage Alzheimer’s need new medicines that delay disease progression,” said Horning in a statement. “This is the first Phase III trial to evaluate a potential disease-modifying medicine in this early prodromal stage of Alzheimer’s disease. We remain committed to investigating new medicines for this devastating illness.”
Gantenerumab is still under investigation in a Phase III trial with patients with later stage disease. Roche also has two other Alzheimer’s compounds in Phase II test, crenezumab and RG1577.
As the result of these stories, Roche shares dropped 5.4 percent, the most in five years. Roche’s partner on the Alzheimer’s trials, German company MorphoSys, had its stock drop 8.1 percent. MorphoSys stock is currently selling for $77.38 per share, down from a recent high of $82.50. Roche shares are currently at $272.20, down from its opening price of $280.00.