Roche will likely be glad to see the end of Friday after a double blow saw it discontinue a late-stage Alzheimer’s disease trial and report disappointing data for breast cancer drug Kadcyla (trastuzumab) in the first-line setting.
The Swiss drug giant said it has decided to discontinue the Phase III SCarlet RoAD study assessing the experimental anti-amyloid medicine gantenerumab in prodromal (pre-dementia) Alzheimer’s disease, based on results of a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee.
No new safety signals for gantenerumab were observed in this analysis and the overall safety profile was similar to that seen in the phase I trial (NN19866), it stressed, adding data will be shared with the medical community at a later stage.
Meanwhile, data from the Phase III MARIANNE trial showed that, while hitting non-inferiority endpoints, breast cancer drug Kadcyla failed to significantly boost progression-free survival compared to Herceptin/chemotherapy in patients with previously untreated, advanced HER2-positive breast cancer.
The company had been hoping to show that the Kadcyla could be used as a first-line approach to improving PFS without the need for traditional chemotherapy, but the data haven’t backed this.
Kadcyla is approved for people with previously treated disease (second and later lines), where it has been shown to extend survival, Roche stressed.
On a brighter note, Roche also announced Friday that it has agreed to acquire Dutalys GmbH, a privately held biotechnology company based in Vienna, Austria.
The group specializes in the discovery and development of fully human, bi-specific antibodies - based on its proprietary DutaMab technology - that are designed to provide novel, best-in-class molecules for several therapeutic areas.