A new radiotherapy for advanced prostate cancer has delivered positive results in a Phase 3 trial when compared with a standard of care for the disease, Novartis announced on 23 March. Lu-PSMA-617 met both primary endpoints of the trial, improving both overall survival and radiographic progression-free survival. The trial enrolled patients whose disease had progressed following prior taxane and androgen receptor-directed therapies.
In a bid to secure an adequate supply of Covid-19 vaccines for the European population, the European Commission has tightened a regulation, introduced at the start of the year, to monitor vaccine exports from the EU to other countries in the world. The move has generated concern from industry groups worried about a possible disruption to vaccine supply chains. However during a press briefing on 24 March, the Commission said the goal of the regulation was to achieve a “security of supply” for Europe while maintaining the integrity of the international trading system.
Roche has stopped dosing patients in a Phase 3 study of an investigational drug for Huntington’s disease, a rare genetic condition that causes nerve cells in the brain to break down. The drug, tominersen, is an antisense therapy designed to reduce the production of all forms of huntingtin protein, including its mutated variant. The trial was the largest study to date in patients with this disease.
An independent data and safety monitoring board (DSMB), which had oversight over AstraZeneca’s latest Covid-19 vaccine trial, has expressed concern that the company may have included outdated information from the trial when it reported an efficacy rate of 79% for the vaccine on 22 March. The DSMB concern was cited in a press release issued by the National Institute of Allergy and Infectious Diseases (NIAID), an agency of the US National Institutes of Health, on 23 March.
The Astra Zeneca/Oxford University vaccine (AZD1222) has shown an efficacy rate of 79% in preventing symptomatic Covid-19 disease and 100% efficacy at preventing severe disease and hospitalisation, AstraZeneca announced on 22 March. The interim data come from a Phase 3 trial conducted in the US which enrolled 32,449 participants. Speaking to reporters, company executives said data from the trial will be filed shortly with the Food and Drug Administration with a view to gaining an emergency authorisation and starting US distribution soon thereafter.
The European Medicines Agency has concluded that the benefits of the AstraZeneca/Oxford University Covid-19 vaccine outweigh the risks despite a possible link to rare blood clots with low blood platelets. The statement was issued on 18 March following a meeting of the agency’s Pharmacovigilance Risk Assessment Committee.
MorphoSys AG saw a significant rise in revenue and liquidity in 2020 following the launch of its cancer drug Monjuvi (tafasitamab) in the US. Revenue was €327.7 million, up from €71.8 million in 2019. Liquidity at the end of the year amounted to €1.24 billion compared with €357.4 million at the end of 2019. Driving up revenue in the year were €18.5 million in sales of Monjuvi and royalty income of €42.5 million from Tremfya for plaque psoriasis. Tremfya was developed by Janssen Research & Development LLC using MorphoSys’ antibody technology.
A Phase 3 trial of the checkpoint inhibitor Libtayo (cemiplimab) is to be stopped early after showing an improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared with chemotherapy, Regeneron Pharmaceuticals Inc and Sanofi SA announced on 15 March. The companies plan regulatory submissions in 2021.
One of several clinical studies of canakinumab in non-small cell lung cancer has failed to meet its primary endpoint, but other studies in the programme are continuing, Novartis announced on 9 March 2021. Canakinumab is a monoclonal antibody designed to neutralise the bioactivity of human interleukin-1beta (IL-1beta). The Phase 3 CANOPY-2 trial, which was evaluating canakinumab in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival.
The European Commission has given a conditional marketing authorisation to the Covid-19 vaccine developed by Janssen Pharmaceutica NV following a positive scientific review by the European Medicines Agency. The decision, announced on 11 March, comes just under two weeks after the US gave the same vaccine an emergency use authorisation.