29 Mar 2019 by AXXELIS
How Will The Failure Of Biogen’s Alzheimer’s Drug, Aducanumab, Impact R&D?
The landscape of experimental Alzheimer’s disease (AD) drugs is strewn with failures, so much so that it has been referred to as “an unrelenting disaster zone”. Recognizing the greatly increasing number of patients with this disease, many biopharma companies have invested a lot of resources in attacking this problem, only to be turned away in late stage studies as happened to Merck with its BACE inhibitor, verubecestat, and Lilly with its beta-amyloid antibody, solanezumab.
FDA approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS]=12.3 vs. 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared to chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77, 95% CI: 0.62-0.96; p=0.017). Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.