AstraZeneca, Roche Lead Pipeline NewsBy
A roundup of the latest drug pipeline news, including from the pharmaceutical majors, featuring news from AstraZeneca and Roche.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 10, 2017 to Tuesday May 16, 2017.
AstraZeneca Has Setback for Late-Stage Severe Asthma Drug
AstraZeneca and its global biologics research and development arm, MedImmune, report that tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody for treating severe, uncontrolled asthma, did not meet its primary endpoint in a Phase III clinical trial.
The trial was evaluating the safety and efficacy for reducing the rate of asthma exacerbations in adults and adolescents with severe, uncontrolled asthma despite receiving inhaled corticosteroids plus long-acting beta2-agonists. AstraZeneca said it will continue to evaluate tralokinumab in a Phase III trial for this indication in a narrower patient population validated through biomarker identification.
Tralokinumab is an anti-IL-13 human immunoglobulin-G4 monoclonal antibody that blocks binding and signalling of IL-13 to IL-13 receptors. IL-13 is a signalling protein that is a driver in asthma. When IL-13 binds to receptors (IL-13Rα1 and IL-13Rα2) found on cells in the airways, it can lead to inflammation, hypersensitivity and structural changes, according to information from the company.
Roche Has Late-Stage Setback for Additional Indication for Bladder Cancer Drug
Roche reports that a Phase III clinical study that evaluated the company’s Tecentriq (atezolizumab), a drug to treat bladder cancer, did not meet its primary endpoint of overall survival compared to chemotherapy.in a Phase III study for an additional indication: in people with locally advanced or metastatic urothelial cancer (mUC, a common form of bladder cancer) whose disease progressed during or after treatment with a platinum-based chemotherapy (previously treated).
Tecentriq, an anti-PD-L1 monoclonal antibody, was approved by the US Food and Drug Administration (FDA) in 2016 to treat locally advanced or metastatic UC whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment.
The FDA recently granted accelerated approval to Tecentriq as an initial treatment for people with locally advanced or mUC who are not eligible for cisplatin chemotherapy. A Phase III pivotal study, is currently ongoing in this population.
Roche has an extensive clinical trial development program for the drug with more than 30 trials ongoing, 17 of which are ongoing or planned Phase III studies across several kinds of lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, and blood cancers. This includes trials evaluating Tecentriq both alone and in combination with other medicines.