Abigail Beaney

5 days ago | clinicaltrialsarena.com | Abigail Beaney

Novartis is hoping that Scemblix (asciminib) will become the physician’s first choice of therapy for chronic myeloid leukaemia in chronic phase (CML-CP) after it has shown to be more tolerable than the standard of care (SOC) in a Phase IIIb trial. Scemblix is a first-in-class STAMP inhibitor which received accelerated approval by the US Food and Drug Administration (FDA) in 2021 in previously treated CML in adult patients.

5 days ago | pharmaceutical-technology.com | Abigail Beaney

MSD is also investigating the KRAS G12C inhibitor in two Phase III trials. MSD investigated the KRAS G12C inhibitor in patients with solid tumours, including advanced colorectal cancer and non-small cell lung cancer. Image credit: Shutterstock / Atmosphere1. MSD’s investigational KRAS G12C inhibitor has shown signs of anti-tumour activity when used both alone and in combination with other oncology drugs.

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Merck KGaA’s antibody-drug conjugate (ADC), precemtabart tocentecan, has shown to be safe and tolerable in a Phase Ib trial. The ongoing PROCEADE-CRC-01 study (NCT05464030) is investigating the dose, safety and tolerability of intravenous (IV) precemtabart tocentecan in approximately 200 patients with metastatic colorectal cancer (mCRC). The study is also looking at early signs of efficacy. Two doses of the drug, 2.4mg/kg and 2.8mg/kg, are being investigated, with patients dosed every three weeks.

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Intellia Therapeutics’ stock has fallen nearly 23% following an announcement that a patient in its Phase III trial for a gene therapy targeting transthyretin amyloid (ATTR) cardiomyopathy suffered a serious adverse event (AE). In a filing by the Securities and Exchange Commission (SEC), the company reported that one patient experienced Grade 4 liver transaminase elevations after treatment with nexiguran ziclumeran (nex-z) in the Phase III MAGNITUDE trial (NCT06128629).

1 week ago | clinicaltrialsarena.com | Abigail Beaney

GSK and Spero Therapeutics’ Phase III trial of their oral antibiotic for complicated urinary tract infections (cUTI) will end early after successfully meeting its primary endpoint. The decision to end the trial, which was investigating tebipenem HBr, was made after a recommendation from an Independent Data Monitoring Committee (IDMC) based on pre-specified interim analysis from the pivotal PIVOT-PO trial (NCT06059846).