AstraZeneca Plc has reported positive data from a Phase 3 trial of its antibody-drug conjugate datopotamab deruxtecan in patients with metastatic hormone receptor (HR) positive, HER2-low or negative breast cancer, the most common breast cancer subtype, accounting for more than 65% of cases diagnosed globally. The trial enrolled 700 patients across five continents.
Yescarta, a chimeric antigen receptor (CAR) T cell therapy, has delivered positive results in a Phase 2 study of patients with relapsed or refractory large B cell lymphoma after one prior therapy. The patients were all ineligible for chemotherapy and autologous stem cell transplantation. Yescarta (axicabtagene ciloleucel) is already approved for several lymphoma indications in the US and Europe.
A Phase 2 trial of a gene therapy for geographic atrophy secondary to dry age-related macular degeneration has been stopped for lack of efficacy, Syncona Ltd, the UK developer, announced on 11 September. This followed a recommendation by the trial’s independent data monitoring committee which concluded that the overall benefit/risk assessment of the therapy didn’t support continuation.
The first patient in a trial of a new radiopharmaceutical has been dosed – paving the way for a potentially new treatment for extensive stage small cell lung cancer, the developer Ariceum Therapeutics GmbH announced on 7 September. The Phase 1b study is taking place at the Murdoch University Health Center in Perth, Australia. It will investigate the safety and tolerability of a theranostic, or a diagnostic agent paired with the radiopharmaceutical product, 177Lu-satoreotide tetraxetan.
A Phase 3 trial of the kinase inhibitor Alecensa (alectinib) has shown a statistically significant improvement in disease-free survival in patients with early-stage anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer, Roche reported on 1 September. Alecensa is already approved for advanced ALK-positive lung cancer. The latest data have now shown effectiveness in an early disease setting as well. ALC-positive lung cancer is a molecular subset of non-small cell lung cancer with distinct pathological features.
Novo Nordisk A/S’s weight loss drug semaglutide (Wegovy) has achieved significant reductions in heart failure-related symptoms in people with heart failure with preserved ejection fraction and obesity in the Phase 3 STEP HFpEF trial. Novo announced the trial results on 25 August. They were simultaneously published in The New England Journal of Medicine. The Phase 3 trial is one of more than 12 studies investigating semaglutide, a glucagon-like peptide-1 receptor agonist, at a dose of 2.4 mg per week.
Merck & Co Inc and its partner Eisai Co Ltd have discontinued a combination study of Keytruda and Lenvima in head and neck squamous cell carcinoma because it failed to show an improvement in overall survival compared with Keytruda and placebo, the companies announced on 25 August. Called LEAP-010, the Phase 3 trial was intended to explore whether the combination could improve treatment options for patients with recurrent head and neck cancer. The study enrolled 511 individuals.
Data from the first-ever efficacy trial of the shingles vaccine Shingrix in China have shown the product to be 100% effective. The trial included nearly 6,000 participants who were randomised to receive Shingrix or a placebo. No cases of shingles were reported amongst those receiving the vaccine compared with 31 cases in the placebo arm, the developer GSK Plc announced on 23 August.
Remibrutinib, a small molecule treatment for chronic spontaneous urticaria (CSU), or hives, has met all primary and secondary endpoints in two Phase 3 studies involving more than 900 patients, Novartis reported on 9 August. A final readout of the trials and regulatory submission are expected in 2024. Remibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor that prevents the release of histamine, a signalling chemical in the immune system that causes itching and swelling on the skin, key features of the disease.
An obesity drug marketed by Novo Nordisk A/S has been shown to reduce the risk of major adverse cardiovascular events in adults who are overweight. The drug, semaglutide (Wegovy), has been approved in both the US and Europe as an adjunct to diet and exercise for the treatment of obesity. Now its effectiveness as a potential agent for lowering cardiovascular risk has been demonstrated for the first time in a clinical trial.