Merck & Co Inc has stopped a trial of Keytruda (pembrolizumab) which was being investigated to treat prostate cancer as part of a combination therapy with the hormone medicine enzalutamide and androgen deprivation therapy. The decision was based on the recommendation of the trial’s independent data monitoring committee on the basis of data from the Phase 3 KEYNOTE-991 trial. The decision was announced on 25 January.
The US Food and Drug Administration has issued a complete response letter (CRL) to Eli Lilly and Company for its application for an accelerated approval of the investigative treatment for Alzheimer’s disease donanemab. A CRL is a formal notice to a company in which the agency explains why it cannot accept an application for a drug approval, usually citing deficiencies in the application itself. Donanemab is a monoclonal antibody that targets beta amyloid plaque in the brain for the treatment of patients with early symptomatic Alzheimer’s disease.
A Phase 3 trial of a candidate vaccine to prevent infection from the human immunodeficiency virus (HIV) has failed and the clinical trial is being discontinued, Janssen Pharmaceutical Companies announced on 18 January. The decision was taken on the advice of the study’s independent Data and Safety Monitoring Board which concluded that the vaccine was not effective in preventing HIV infection compared with a placebo. No safety issues related to the vaccine were identified.
The Roche Group has reported the success of a combination therapy in reducing the risk of cancer recurrence in patients with early-stage hepatocellular carcinoma. A Phase 3 trial which combined the immune checkpoint inhibitor Tecentriq (atezolizumab) and Avastin (bevacizumab) and was administered as an adjuvant treatment after surgery, showed a statistically significant improvement in recurrence-free survival in patients at an increased risk of their disease returning.
CureVac NV and its partner GSK Plc have reported promising preliminary data from ongoing Phase 1 studies of vaccine candidates directed against both Covid-19 and influenza. The experimental medicines are based on messenger RNA. The results showed that vaccine candidates using a modified second-generation mRNA backbone produced promising immunogenicity and reactogenicity profiles in both indications. The modified vaccines are directed against specific antigens.
Switzerland-based MetrioPharm AG has reported top-line data for a candidate treatment for Covid-19, showing that the compound is as effective as two approved antiviral medicines for the disease. The drug, MP1032, is a small molecule macrophage metabolic modulator which targets activated macrophages. It acts by normalising oxidation-reduction reactions at a cellular level which is essential for the body’s immune response to infections and autoimmune and inflammatory diseases.
A second Phase 3 trial of ensifentrine, a candidate product for chronic obstructive pulmonary disease (COPD), has met its primary endpoint, paving the way for a regulatory submission in the US in the first half of 2023, the developer Verona Pharma Plc announced on 20 December. Ensifentrine is a dual inhibitor of the enzymes phosphodiesterase 3 and 4, a mode of action that enables it to combine both bronchodilator and anti-inflammatory effects in a single compound.
An experimental messenger RNA (mRNA) cancer vaccine has generated positive data in combination with Keytruda (pembrolizumab) in patients with advanced melanoma, the developers Moderna Inc and Merck & Co announced on 13 December.
An allogeneic dendritic cell vaccine for patients who have residual cancer after previous successful treatments with chemotherapy has shown positive survival data, according to the developer Mendus AB. The treatment, DCP-001, is being evaluated in a Phase 2 trial as a maintenance therapy in acute myeloid leukaemia (AML) for patients with measurable residual disease. Fresh data from the trial, ADVANCE II, was reported at the American Society of Hematology Annual Meeting on 12 December.
A Phase 3 trial of a small molecule drug designed to treat patients with metastatic non-small cell lung cancer failed to meet its primary endpoint of overall survival, the sponsor Ipsen SA announced on 8 December. Cabozantinib was being investigated in 366 patients with both squamous and non-squamous non-small cell lung cancer whose disease had progressed after treatment with a checkpoint inhibitor and chemotherapy.