Testing a new treatment for Crohn’s disease

Northwestern: Patients with moderate to severe Crohn’s disease showed significant improvement on a drug called ustekinumab, according to the results of phase III clinical trials published in the New England Journal of Medicine. The study was co-authored by Stephen Hanauer, MD, the Clifford Joseph Barborka Professor of Medicine in the Division of Gastroenterology and Hepatology. Crohn’s disease is an inflammatory condition of the gastrointestinal tract, characterized by severe abdominal pain, diarrhea and weight loss. Current therapies, such as immunosuppressants, can help control symptoms of the disease, but they have limited efficacy and can carry an increased risk of infection.

Pembrolizumab in lung cancer: indication of considerable added benefit

IQWIG: Advantages notably outweigh disadvantages in comparison with docetaxel / added benefit over best supportive care not proven.Pembrolizumab (trade name: Keytruda) was initially introduced for the treatment of melanoma. Since July 2016, the monoclonal antibody has also been available for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express the T-cell receptor ligand PD-L1 and who have received a prior chemotherapy regimen. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether the drug offers an added benefit over the appropriate comparator therapy also for these patients.

Biosimilar Drug Shows Potential as Breast Cancer Treatment

JAMA: Among women with metastatic breast cancer, treatment with a drug that is biosimilar to the breast cancer drug trastuzumab resulted in an equivalent overall response rate at 24 weeks compared with trastuzumab, according to a study published online by JAMA. Biological agents, including monoclonal antibodies, have increased the treatment options and greatly improved outcomes for a number of cancers. However, patient access to these biologics is limited in many countries. With impending patent expiration of some biological agents, development of biosimilars has become a high priority for drug developers and health authorities throughout the world to provide access to high-quality alternatives. A biosimilar drug is a biological product that is highly similar to a licensed biological product, with no clinically meaningful differences in terms of safety or potency.

Failed Alzheimer’s trial does not kill leading theory of disease

Nature: A drug that was seen as a major test of the leading theory behind Alzheimer’s disease has failed in a large trial of people with mild dementia. Critics of the ‘amyloid hypothesis’, which posits that the disease is triggered by a build-up of amyloid protein in the brain, have seized on the results as evidence of its weakness. But the jury is still out on whether the theory will eventually yield a treatment. Proponents of the theory note that the particular way in which solanezumab, the drug involved in the trial, works could have led to the failure, rather than a flaw in the hypothesis itself. And many trials are ongoing to test whether solanezumab — or others that target amyloid — could work in people at risk of the disease who have not yet shown symptoms, or even in people with Alzheimer’s, despite the latest negative result.

Penn Medicine's New Immunotherapy Study Will Pit PD-1 Inhibitor Against Advanced Lung Cancer

Pennsylvania University. US: Penn Medicine researchers have begun a new immunotherapy trial with the “checkpoint inhibitor” known as pembrolizumab in patients with oligometastatic lung cancer—a state characterized by a few metastases in a confined area—who have completed conventional treatments and are considered free of active disease but remain at a high risk for recurrence. 

FDA approves Opdivo for advanced melanoma

The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.