A Phase 3 trial of a candidate immunotherapy for lung cancer, which was being compared with pembrolizumab, has been discontinued, the sponsor Merck KGaA announced on 20 January. The decision was taken on a recommendation of the trial’s independent data monitoring committee which said the study was unlikely to meet the co-primary endpoint of progression-free survival. The trial is known as INTR@PID Lung 037.
A Phase 3 study of a prospective asthma treatment failed to meet its primary endpoint even though a registration trial for the same drug had positive results. The developers, Amgen Inc and AstraZeneca Plc, said the discrepancy may be due to the design of the failed study, but a further analysis of the data is ongoing.
The US Food and Drug Administration has placed a clinical hold on uniQure NV’s gene therapy programme in haemophilia B following a possibly related serious adverse event, the company announced on 21 December. The hold affects the company’s pivotal Phase 3 study called HOPE-B which recently reported positive initial data at the annual meeting of the American Society of Hematology (ASH).
The US Food and Drug Administration has issued an emergency use authorisation to Moderna Inc for a vaccine for Covid-19 following trial data showing it was 94.1% effective in preventing the disease. The decision comes just a week after the agency issued an emergency authorisation for a vaccine developed by BioNTech SE and its partner Pfizer Inc. Both vaccines are based on messenger RNA (mRNA), a technology never before used in a human vaccine. The two vaccines work by instructing cells in the body to make copies of the SARS-CoV-2 spike protein.
Sanofi SA and its partner GlaxoSmithKline Plc are to test a new antigen formulation for their Covid-19 vaccine in order to generate a better response from older adults. Assuming all data are positive, the vaccine would be available in the 2021 fourth quarter rather than mid-2021, the companies announced on 11 December 2020.
Astra Zeneca Plc has announced the publication on 8 December of interim Phase 3 data of a Covid-19 vaccine that it is developing with the University of Oxford in The Lancet. The interim analysis for efficacy and safety, as outlined in the article, are in line with previous disclosures, the company said.
An estimated 44% of patients with advanced lymphoma are still alive four years after receiving a single infusion of Yescarta (axicabtagene ciloleucel) for their disease. The new long-term survival data were presented by Gilead Sciences Inc at the annual meeting of the American Society of Hematology (ASH), further illustrating the efficacy of the chimeric antigen receptor (CAR) T cell therapy class.
Norway-based Targovax ASA has reported promising Phase 1 data for its oncolytic virus treatment ONCOS-102 in combination with pembrolizumab in patients with advanced, unresectable melanoma. The patients had experienced disease progression despite treatment with a checkpoint inhibitor, yet in the study tumour responses were observed in seven out of 20 evaluable patients.
Galapagos NV has reported positive topline data from an early clinical trial of a small molecule antagonist of GPR84 in patients with idiopathic pulmonary fibrosis. The placebo-controlled study enrolled 68 patients but was not powered to show statistical significance. Nevertheless, patients receiving the treatment GLPG1205 on top of a standard of care showed a smaller decline in forced vital capacity, a measure of lung function, than those receiving a placebo and standard of care.
Moderna Inc is poised to make regulatory filings in the US and Europe today for its Covid-19 vaccines. This follows the release of new data from a Phase 3 study showing that the messenger RNA (mRNA) vaccine achieved an efficacy rate of 94.1%. The placebo-controlled study involves 30,000 participants.