Clinical Research

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.

A Phase 3 trial designed to generate a new cancer indication for Venclexta (venetoclax) failed to meet its primary endpoint of a statistically significant improvement in overall survival in acute myeloid leukaemia, AbbVie Inc announced on 28 February. Venclexta is being jointly developed with Roche and already has been approved in four cancer indications. The newest trial compared Venclexta in combination with the chemotherapy cytarabine against a combination of cytarabine and placebo. Patients in the trial had AML and were ineligible for intensive chemotherapy.

Gilead Sciences Inc has launched two Phase 3 studies of an experimental nucleotide analog to treat adults diagnosed with infection from the COVID-19 coronavirus. The studies will assess two dosing durations of the drug remdesivir, administered intravenously. They follow the US Food and Drug Administration decision to accept Gilead’s clinical trial application.

Remdesivir has been tested in humans with Ebola virus disease and in animal models for Middle East respiratory syndrome and severe acute respiratory syndrome, which are caused by other coronaviruses.

Positive long-term data have been reported for a cell therapy being tested in patients with retinitis pigmentosa, a group of hereditary diseases of the eye that can lead to a progressive loss of vision and blindness. Results from the ongoing US Phase 1/2a study of the human retinal progenitor cell therapy showed a meaningful clinical effect at all points in time out to 12 months after treatment.

The mode of action of an experimental treatment for septic shock has been confirmed in a Phase 2 study, paving the way for further development of the therapy in patients with an early stage of the disease. Septic shock is a life-threatening organ dysfunction caused by the body’s response to infection. The trial, AdrenOSS-2, enrolled 301 patients who were identified by a novel biomarker as having early septic shock and elevated blood levels of the peptide hormone adrenomedullin. They were treated with the monoclonal antibody adrecizumab.