Clinical Research

Johnson & Johnson Inc has announced the selection of a lead vaccine candidate to test against COVID-19, the disease caused by the coronavirus SARS-CoV-2, and intends to start clinical studies by September at the latest. The first batches of the vaccine could be available for approval under an emergency use regulation by early 2021, the company said on 30 March.

A Phase 3 trial of the Type 2 diabetes drug Farxiga (dapagliflozin), which was being in tested in patients with chronic kidney disease, is to be stopped early on efficacy grounds. This follows a recommendation by the trial’s independent data monitoring committee. Announcing the decision on 30 March, AstraZeneca Plc said the committee had concluded that patients in the trial experienced “overwhelming benefit” from the drug.

Positive data has been reported for the cancer drug Venclexta (venetoclax) in combination with azacitidine chemotherapy in a Phase 3 trial of patients with previously untreated acute myeloid leukaemia (AML), according to the co-developers AbbVie Inc and Roche. The trial, VIALE-A and a second study, VAILE-C, are being conducted in order to confirm an accelerated approval of Venclexta for AML which was issued by the US Food and Drug Administration in 2018.

Pharmaceutical regulators from 17 countries have agreed in principle on the criteria that must be met before developers of candidate vaccines for the coronavirus SARS-CoV-2 start human trials. The officials held a virtual meeting on 18 March, and a summary of their conclusions was released by the European Medicines Agency on 24 March.

The European Medicines Agency has issued a statement urging the research community to give priority to large randomised controlled studies when investigating potential treatments for COVID-19 and to include all EU countries in these trials.

New guidance on the conduct of clinical trials during the COVID-19 pandemic has been published by the European Commission, the European Medicines Agency and heads of national agencies in the EU. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf, Developers including Eli Lilly and Co, have already announced delays in the start of studies and a pause

A therapeutic cancer vaccine consisting of synthetic long peptides has delivered a meaningful survival benefit for cervical cancer patients when administered in combination with standard-of-care chemotherapy. The Phase 2 trial showed that the vaccine and carboplatin/paclitaxel chemotherapy were associated with prolonged survival.

A clinical study in which orally-delivered bacteria have been combined with the checkpoint inhibitor Keytruda has shown promising results in six patients with a variety of advanced cancers. The developer, 4D pharma Plc, said the data represent the first global confirmation that a live biotherapeutic product can initiate a response in cancer patients. It noted that a microbiome product combined with a checkpoint inhibitor might improve the efficacy of the checkpoint therapy.

Roche has announced plans to start a placebo-controlled Phase 3 trial of its rheumatoid arthritis drug Actemra (tocilizumab) in adults in hospital with pneumonia caused by the coronavirus. The trial is to be conducted in collaboration with the US Biomedical Advanced Research and Development Authority (BARDA). It will evaluate Actemra, plus a standard of care, compared with placebo plus a standard of care.

A Phase 3 trial of a new drug combination for ovarian cancer failed to meet its primary endpoint, AstraZeneca Plc announced on 12 March. The trial was investigating cediranib, an experimental vascular endothelial growth factor receptor (VEGFR) inhibitor, with Lynparza (olaparib), an approved cancer drug that targets DNA damage response in cells and tumours.