The immune checkpoint inhibitor Tecentriq (atezolizumab) met its primary endpoint of disease-free survival in a Phase 3 study in people with early non-small cell lung cancer, Roche announced on 22 March. The interim analysis showed the drug improved outcomes as an adjuvant therapy following surgery and chemotherapy. At the time of the analysis, data on overall survival were immature.
AstraZeneca Plc has issued fresh data from its US Phase 3 trial of a Covid-19 vaccine developed jointly with Oxford University (AZD1222) showing an efficacy rate of 76% against symptomatic disease. The primary efficacy analysis included the accrual of 190 symptomatic cases of Covid-19 from the 32,449 trial participants. This represents an additional 49 cases as compared with an interim analysis of the trial which was published on 22 March and showed an efficacy rate of 79%.
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.
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oversight over AstraZeneca’s latest Covid-19 vaccine trial, has expressed concern that the company may have included outdated information from the trial when it reported an efficacy rate of 79% for the vaccine on 22 March.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.
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.
An experimental oncolytic virus therapy in clinical development by Targovax ASA has continued to show a survival benefit for patients with malignant pleural mesothelioma 21 months after treatment. At follow-up, half of the patients in the first-line treatment group were still alive and median overall survival had not been reached, the company announced on 23 February.
A small molecule drug being developed by Immunic Inc has shown evidence of clinical activity in hospitalised patients with moderate Covid-19 disease, the company announced on 17 February. The finding, from a Phase 2 trial, suggests that the drug, IMU-838, may have application in patients aged over 65 years, as well as preventing long-term Covid-19 symptoms such as fatigue.