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 in enrollment of ongoing studies.
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.
A Phase 3 study of the anti-PD-L1 antibody avelumab (Bavencio) has been stopped early after the trial’s data monitoring committee said it was unlikely to meet its primary endpoint. The sponsors, Merck KGaA and Pfizer Inc, announced the decision on 13 March.
Results from a Phase 2 study of a new treatment for the chronic skin condition, prurigo nodularis, showed that the antibody performed better on a pruritus rating scale than placebo and also delivered clear or nearly clear skin for over one third of participants. Results of the trial were published in the New England Journal of Medicine on 20 February.
An experimental therapeutic cancer vaccine with a dual mode of action has passed its first clinical hurdle and will continue to be investigated as a first-line therapy in patients with metastatic non-small cell lung cancer (NSCLC). The vaccine, IO102 is being developed by IO Biotech ApS of Denmark in combination with Keytruda. An interim Phase 2 analysis, designed as a futility analysis, showed that the vaccine delivered an objective response rate that was substantially higher than Keytruda monotherapy had done in patients with a similar profile.