A Phase 3 study of the checkpoint antibody Tecentriq (atezolizumab) did not meet its primary endpoint of disease-free survival compared with observation in patients with muscle-invasive urothelial cancer, the developer Roche announced on 24 January.
An experimental treatment for Type 1 spinal muscular atrophy (SMA) has reached its primary endpoint in a pivotal trial of infants, paving the way for a US regulatory decision by late May, according to the developer Roche. The drug, risdiplam, is a small molecule that works by increasing the amount of protein produced by the survival motor neuron-2 (SMN2) gene.
Norway-based Targovax ASA has reported promising early data from a trial of its oncolytic virus ONCOS-102, in combination with chemotherapy, in patients with malignant pleural mesothelioma. Malignant mesothelioma is a tumour of the tissue surrounding the lungs, stomach and heart and is caused by exposure to asbestos fibres.
CureVac AG has reported positive Phase 1 data from a trial in healthy volunteers of an experimental rabies vaccine based on messenger RNA (mRNA). The prophylactic vaccine, CV7202, encodes the rabies virus glycoprotein RABV-G in a lipid nanoparticle formulation.
Boehringer Ingelheim GmbH has encountered a setback in its plans to develop multiple products for non-alcoholic steatohepatitis (NASH). A small molecule drug in-licensed from Pharmaxis Ltd in Australia is being dropped from development because of the risk of drug interactions, the German company said on 18 December.
A large observational study of patients with atrial fibrillation treated with the cardiovascular drug Lixiana (edoxaban), has confirmed that the drug is noninferior to warfarin but generates fewer bleeding episodes, according to the developer, Daiichi Sankyo Co Ltd.
A combination therapy directed at patients with advanced non-squamous non-small cell lung cancer, failed to show a clinically meaningful overall response rate in a Phase 2 clinical trial, the developer Transgene SA announced on 12 December. Transgene has stopped further development of the compound TG4010, which is a cancer vaccine based on a modified Vaccinia virus.
The antibody-drug conjugate belantamab mafodotin has generated an overall response rate of 31% in a pivotal Phase 2 study of patients with relapsed/refractory multiple myeloma, GlaxoSmithKline Plc announced on 17 December. The UK company has made a regulatory submission for the drug with the US Food and Drug Administration.
Novartis is to discontinue development of the small molecule drug fevipiprant as a treatment for asthma following the failure of two Phase 3 studies to show a reduction in the rate of moderate-to-severe exacerbation compared with placebo. A pooled analysis of the LUSTER-1 and LUSTER-2 studies did not meet the clinical threshold of efficacy for either of the two doses of the drug over a period of 52 weeks.
“The totality of these results do not support further development of fevipiprant in asthma,” the company said in a statement on 16 December.
New long-term data for the cancer therapy Yescarta (axicabtagene ciloleucel) have shown that nearly half of patients treated with the cell-based gene therapy were alive three years after treatment. The long-term data were presented on 7 December at the American Society of Hematology meeting in the US, and are similar to outcome data reported in 2017.