Clinical Research

Novartis, Amgen Inc and the non-profit organisation Banner Alzheimer’s Institute have stopped two pivotal studies of umibecestat, a candidate Alzheimer’s drug, because a review identified a worsening in some measures of cognitive function among patients. The trial was intended to run until 2025.

MorphoSys AG has upgraded its financial guidance for 2019 following a decision by GlaxoSmithKline Plc to start Phase 3 trials of one of its antibodies. This triggers a €22 million milestone payment to MorphoSys. The German company now expects revenue this year will be between €65-72 million, up from €43-50 million previously, and its loss before interest and tax to narrow to €105-115 million from €127-137 million previously.

MorphoSys AG said that a single-arm Phase 2 study of its monoclonal antibody, tafasitamab (MOR208), in patients with relapsed lymphoma met its primary endpoint, paving the way for completion of a regulatory submission in the US by the end of the year.

A research alliance between German BioNTech SE and Genmab A/S of Denmark has yielded its first product – a clinical stage bispecific antibody that is being investigated in patients with metastatic or unresectable malignant solid tumours. Called DuoBody-PD-L1x4-1BB, the jointly developed product started a Phase 1/2a study on 17 June. It has a dual mode of action that combines checkpoint blockade with the conditional stimulation of T cells.

It is estimated that up to 7% of patients with pancreatic cancer have a mutation in the tumour suppressor genes BRCA1 and BRCA2, impairing the body's ability to repair damaged DNA and allowing tumours to grow. BRCA mutations also drive ovarian and breast cancers, but they can be particularly lethal in pancreatic tumours because this cancer is difficult to detect at an early stage.

AstraZeneca Plc’s Bruton tyrosine kinase inhibitor Calquence, already approved in the US for mantle cell lymphoma, has delivered positive results in a Phase 3 trial of previously-treated patients with chronic lymphocytic leukaemia. The trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival and will stop early, the company announced on 6 May. Calquence was administered as a monotherapy and compared with a combination of rituximab and a physician’s choice of either idelalisib or bendamustine.

MorphoSys AG has reported positive data from a single-arm Phase 2 study of its investigational monoclonal antibody tafasitamab with the cancer drug lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma. The drug, previously known as MOR208, is being prepared for a regulatory submission to the US Food and Drug Administration by the end of the year.

Another attempt to produce an effective therapy for glioblastoma multiforme (GBM), an aggressive brain cancer, has failed. This time it was a study testing the checkpoint antibody Opdivo (nivolumab) plus radiation in patients with newly diagnosed disease. The Phase 3 trial, known as CheckMate-498, did not meet its primary endpoint of overall survival at final analysis, according to the sponsor Bristol-Myers Squibb Co.

The US Food and Drug Administration has issued its first-ever draft guidance on the development of stimulant drugs to treat attention deficit hyperactivity disorder (ADHD), a condition whose symptoms include inattention and high levels of activity. While many of the recommendations are already in practice, the document gives clarification on the agency’s expectations for clinical trial design.

A Phase 3 trial investigating a new small molecule drug for advanced fibrosis failed to meet its primary endpoint, sending the developer Gilead Sciences Inc back to the drawing board. The drug, selonsertib, was being investigated in patients with stage 3 fibrosis due to non-alcoholic steatohepatitis (NASH), a progressive liver disease characterised by the accumulation of fat and inflammation in the liver.