Articles related to CLINICAL TRIALS

Results from the RUBY trial of dostarlimab and the GY018/Keynote-068 of pembrolizumab were presented at the 2023 SGO Annual Meeting on Women’s Cancer in March and were simultaneously published in The New England Journal of Medicine. The studies examined the efficacy and safety of the medications in all individuals and those with mismatch repair deficient (dMMR) illness. Each trial examined a separate PD-1 inhibitor, pembrolizumab or dostarlimab, in combination with chemotherapy in patients with advanced or recurrent endometrial cancer. In individuals with dMMR illness, both medications lowered the chance of disease progression or death by roughly 70%.

Twenty-seven (27) children with heavily pretreated neuroblastoma (12 with refractory disease, 14 with relapsed disease, and one with a complete response at the end of first-line therapy) were enrolled in this academic, phase 1-2 clinical trial to test autologous, third-generation GD2-CAR T cells expressing the inducible caspase 9 suicide gene (GD2-CART01). The use of GD2-CART01 in the treatment of high-risk neuroblastoma was feasible and safe. Treatment-related toxic effects emerged, and the suicide gene was activated to control side effects. GD2-CART01 may have long-term antitumor activity.

Athira’s safety and efficacy trial, geared for 75 patients, will run with a smaller-than-planned 28 patient study population. The trial is for the small molecule fosgonimeton, an activator of the HGF/MET pathway, postulated to offer neuroprotective effects to improve brain function in patients with Parkinson’s dementia.

Dr. Christopher Flowers, professor and chair of the Lymphoma Myeloma Department at the University of Texas MD Anderson Cancer Center, discusses the GO29365 study, which examined the combination of polatuzumab vedotin and bendamustine rituximab. The trial’s exploratory nature involved looking at the combination of polatuzumab vedotin with bendamustine and rituximab in a dose-finding component to determine the best dose to give to patients with follicular lymphoma and diffuse large B-cell lymphoma.

The findings of this randomized clinical trial support the notion that, despite improved DFS, patients 60 years or younger with intermediate-risk AML, as defined by Medical Research Council cytogenetic criteria, do not benefit from allo-HCT during first CR in terms of OS. Early identification of a suitable donor allows for the timely rescue of patients who have relapsed following conventional consolidation chemotherapy. Future research that uses longitudinal monitoring of residual disease dynamics will aid in personalizing the optimal time point for allo-HCT in the majority of patients.

Top-line data from an open-label Phase 2 study of 216 people with mild-to-moderate Alzheimer’s disease treated with simufilam tablets at 100 mg twice daily for a year revealed a minimal decline in cognitive ability overall, as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11). Simufilam was found to be safe and well tolerated, and it alleviated depression and dementia-related behaviors in patients, which were two exploratory trial goals.