Clinical Research

Second Phase 3 failure for AZ’s Fasenra

Country
United Kingdom

AstraZeneca Plc’s biologic drug for respiratory disease, Fasenra (benralizumab), has failed a second Phase 3 trial in patients with chronic obstructive pulmonary disease (COPD). As a result, the company said it will not to make a regulatory submission for this indication.

Daratumumab combination studies stopped

Country
Denmark

An early clinical study of the monoclonal antibody daratumumab (Darzalex) in combination with the checkpoint inhibitor atezolizumab in patients with non-small cell lung cancer has been stopped early because of lack of efficacy as well as safety issues, Genmab A/S announced on 26 May.

GSK reports long-term benefit of Nucala

Country
United Kingdom

A multi-year study of the asthma drug Nucala (mepolizumab) has shown the treatment to be effective in asthma control and reducing acute episodes of the disease, according to GlaxoSmithKline Plc. The company disclosed the data on 20 May at a meeting of the American Thoracic Society.

Positive Phase 3 results for Dupixent

Country
France

Dupixent (dupilumab) has delivered positive results in a Phase 3 trial involving adolescents with moderate-to-severe atopic dermatitis. The drug is already approved for the same disease in adults and is the first biologic to show a benefit in this patient group.

NOXXON gives update on cancer study

Country
Germany

NOXXON Pharma NV has reported a promising response from a patient with metastatic pancreatic cancer to its RNA oligonucleotide drug that is intended to fight cancer by targeting the tumour microenvironment. The company gave the update on 16 May at the BioEquity Europe conference in Belgium.

AZ drug for COPD fails first of two Phase 3 trials

Country
United Kingdom

AstraZeneca Plc’s antibody drug for chronic obstructive pulmonary disease (COPD), Fasenra (benralizumab), has failed to meet its primary endpoint in the first of two Phase 3 trials of patients with the disease.

Roche combination trial fails

Country
Switzerland

A Phase 3 trial evaluating a combination of the checkpoint antibody Tecentriq (atezolizumab) and the kinase inhibitor Cotellic (cobimetinib) in patients with metastatic colorectal cancer failed to meet its primary endpoint of overall survival, Roche announced on 10 May.

GeNeuro targets retrovirus protein in MS

Country
Switzerland

Recent positive data from a Phase 2b trial of patients with multiple sclerosis illustrates the role of pathogenic HERV-W protein in the genesis of the disease. The protein was neutralised by an antibody therapy developed by GeNeuro SA, the first time this has been shown in a clinical trial.

Combination IO study in melanoma stopped

Country
United States

A Phase 3 trial in which a combination of Keytruda (pembrolizumab) and the IDO1 inhibitor epacadostat were being studied in patients with metastatic melanoma has been stopped after failing to show a benefit in progression-free survival, according to Incyte Corp and Merck & Co Inc.

Vobarilizumab fails in systemic lupus erythematosus

Country
Belgium

Vobarilizumab, a protein therapeutic that showed efficacy at Phase 2 in rheumatoid arthritis, has failed to meet the primary endpoint of dose response in a separate Phase 2 study of patients with systemic lupus erythematosus.