Clinical Research

The checkpoint antibody Tecentriq (atezolizumab), when combined with Avastin, has shown  statistically significant and clinically meaningful improvements in overall survival and progression-free survival in patients with unresectable hepatocellular carcinoma, the most common type of primary liver cancer, Roche announced on 22 November. The Phase 3, 501-patient trial compared the combination therapy with sorafenib, the standard of care for advanced liver cancer.

The immunosuppressant Cosentyx (secukinumab) narrowly missed statistical significance for superiority in a head-to-head trial against Humira in patients with active psoriatic arthritis, Novartis announced on 1 November. The 52-week trial, called EXCEED, evaluated the two drugs in more than 800 patients who were naïve to a biologic therapy.

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.