A second experimental Ebola vaccine is to be tested in a large clinical trial in the Democratic Republic of Congo (DRC) as public health authorities mobilise resources to contain an outbreak of Ebola virus disease, declared by the World Health Organization to be a public health emergency.
Like many developers of cancer drugs, MorphoSys AG is using data from a single-arm Phase 2 trial as the basis for a regulatory submission to the US Food and Drug Administration. The company’s L-MIND trial reported positive results in May showing that the antibody tafasitamab, combined with the myeloma drug lenalidomide, met its primary endpoint of objective response in patients with lymphoma. This is the basis of a rolling submission to the FDA.
A vaccine designed to reduce the incidence of pulmonary tuberculosis in HIV-negative adults has shown an overall efficacy rate of 50%, according to the developers GlaxoSmithKline Plc and the international AIDS vaccine initiative (IAVI). The Phase 2b study enrolled adults with latent TB infection, which is estimated to affect one-quarter of the global population. Of this number, an estimated 10% will develop active pulmonary TB disease.
The kinase inhibitor tucatinib has shown a 46% reduction in the risk of breast cancer progression in a Phase 3 trial that enrolled patients who had previously received two antibody treatments and one antibody-drug conjugate. Announcing the results on 21 October, Seattle Genetics Inc said a US regulatory filing is planned for the first quarter of 2020.
A Phase 2 trial of an experimental treatment for atopic dermatitis, MOR106, which was being jointly developed by Galapagos NV, MorphoSys AG and Novartis Pharma AG, has been stopped for futility, the companies announced on 28 October. An interim analysis showed a low probability of the compound meeting it's primary endpoint, defined as the percentage change in the eczema area and severity index score.
Biogen Inc and Eisai Co Ltd have announced plans to seek US regulatory approval for aducanumab, a candidate treatment for early Alzheimer’s disease, just months after two Phase 3 trials for the drug were stopped for futility. The decision to proceed with registration follows discussions with the Food and Drug Administration about a larger dataset from the Phase 3 studies which showed that the drug worked at a high dose.
Scientists at the Netherlands Cancer Institute have reported positive results from a trial of a new combination therapy that includes an inhibitor of the B-Raf protein and an epidermal growth factor receptor (EGFR) inhibitor in patients with BRAF-mutated metastatic colorectal cancer. The treatment was pioneered by René Bernards and colleagues after they discovered why patients with BRAF-mutated colorectal cancer were insensitive to BRAF inhibition.
Safety concerns once again triggered the stoppage of a late-stage Alzheimer’s disease trial with a BACE inhibitor, a small molecule drug intended to limit amyloid-beta production. Eisai Co Ltd and Biogen Inc announced the discontinuation of two studies with elenbecestat on 13 September following a review by the trials’ data safety monitoring board.
Ilixadencel, an allogeneic cell therapy developed by Immunicum AB of Sweden, has achieved complete tumour responses in five out of 45 evaluable patients with metastatic kidney cancer in a Phase 2 trial, compared with just one out of 25 patients receiving standard-of care sunitinib. Announcing the results on 29 August, the company said the data support its vision of positioning ilixadencel as a “backbone therapy” for modern cancer treatment regimens.
GlaxoSmithKline Plc has reported positive Phase 2 data for an antibody-drug conjugate directed against multiple myeloma and announced plans to make regulatory filings later this year. The drug, belantamab mafodotin, showed a clinically meaningful overall response rate in patients with the disease, GSK announced on 23 August.
DREAMM-2 enrolled 223 patients with relapsed multiple myeloma who had not responded to other treatments such as an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. The two-arm study met its primary endpoint of overall response.