Adding Mylotarg to Chemo Fails to Boost Survival in NPM1-Mutated AML
There was bad news and good news in a phase III trial evaluating intensive chemotherapy with or without gemtuzumab ozogamicin (Mylotarg) in acute myeloid leukemia (AML) patients with newly diagnosed, NPM1-mutated disease. For the primary endpoints of event-free survival (EFS) and overall survival (OS), the gemtuzumab ozogamicin-treated group experienced no benefit, but addition of the […]
CDC Offers Tentative Guidance for Severe Mpox Treatment
With no clinical trial data yet available for treating severe mpox, the CDC has published an interim report with guidance. There are many FDA-regulated drugs and biologics stockpiled for smallpox preparedness that can be used to treat severe mpox; however, there are many clinical considerations when using these to help manage strategic decision-making, the CDC […]
What Next After Early End of MOSAICO HIV Vaccine Trial?
SEATTLE — The abrupt and early end of the MOSAICO HIV vaccine trial, announced last month, was the topic of a special session at the Conference on Retroviruses and Opportunistic Infections here. Results of the 3,800-participant trial were negative, with an identical 113 individuals in the vaccine regimen and placebo groups becoming infected with HIV […]
Polypill Tested for Cognitive, Functional Benefits
Reducing blood pressure and cholesterol in the TIPS-3 trial with a polypill, with or without aspirin, showed no protective effect on cognition in older adults with cardiovascular disease risk factors, a secondary analysis showed. During a 5-year follow-up, about the same number of trial participants in TIPS-3 experienced substantive cognitive decline in both the treatment […]
Scattered Brain Bleeds, Vasculitis in Alzheimer’s Trial Death
A fatal bleeding event in an Alzheimer’s clinical trial participant may have been linked with the investigational anti-amyloid agent lecanemab, a case report suggested. However, drug trialists are not willing to assign blame yet, especially as lecanemab’s fate hangs in a potential FDA approval for early Alzheimer’s disease later this week. Information about the case […]
Second Trial Participant Dies in Alzheimer’s Drug Study
Days before the release of promising phase III trial data of lecanemab, an investigational anti-amyloid drug for early Alzheimer’s disease, a death possibly linked to the treatment was reported. An unpublished case report featured in Science suggested the death of a 65-year-old lecanemab trial participant who also had cerebral amyloid angiopathy — a condition in […]
Vitamin D Ruled Out as Solution to Statin Intolerance
Vitamin D supplementation did not ease the muscle symptoms of statin users in the randomized VITAL trial, a substudy showed. Over 4.8 years of follow-up, 31% of statin users assigned to vitamin D reported muscle pain or discomfort lasting several days, which was the same proportion as those assigned placebo, with 13% of both groups […]
‘Potential Detrimental Effect’ With Fourth-Line Olaparib in Ovarian Cancer
NEW YORK — A post-hoc analysis of overall survival (OS) in the SOLO3 trial demonstrated why olaparib (Lynparza) recently had its fourth-line indication in ovarian cancer pulled by drugmaker AstraZeneca. The phase III trial, which tested olaparib versus non-platinum chemotherapy for women with BRCA-mutated platinum-sensitive relapsed disease, found diverging OS signals based on whether women […]
BP Lowering in Pregnant Women Continues to Take Shape
SAN DIEGO — Standard practice has changed since a major trial revealed earlier this year that treating mild hypertension in pregnant women helps them without hurting their children. Nevertheless, questions about the particulars of this approach arose during a discussion at the annual Hypertension meeting hosted by the American Heart Association. In April 2022, the […]
ALS Drug Needs More Evidence, FDA Advisors Say
In a close call, an FDA advisory committee said data from a single trial for AMX0035, an investigational agent being studied to treat amyotrophic lateral sclerosis (ALS), did not support a conclusion that the drug was effective. The 6-4 vote of the Peripheral and Central Nervous System Drugs Advisory Committee was based on findings from […]