Articles related to CLINICAL TRIALS

The Sartor, et al randomized controlled trial (RCT), which demonstrated a significant improvement in radiographic progression-free survival and overall survival (OS) in patients with PSMA-positive mCRPC, served as the foundation for the 177Lutetium-PSMA-617 (177Lu-PSMA-617) March 2022 approval. The availability of this theranostic option served as a compelling argument for revising the 2014 proposal to include a prompt endorsement of 177Lu-PSMA-617. The mCRPC recommendations are now being updated completely.

Until a tumor is determined to be TMB-high or MSI-H/MMRd, and thus qualifies for treatment with pembrolizumab or dostarlimab on the basis of cancer site-agnostic approval, there is no justification for the use of single-agent ICB in unselected populations with recurrent EOC. However, the clinical trials carried out up to this point show that ICB can induce long-lasting responses in a relatively small fraction of individuals. These discoveries offer opportunities and challenges to the medical and scientific communities, including the need to use novel technologies to locate predictive biomarkers and create immunotherapies that go beyond ICB to improve the effectiveness of these drugs.

A Q&A session with Thomas J. Herzog, MD, the Deputy Director at the University of Cincinnati Cancer Center in Ohio, who discusses the PARP inhibitors olaparib (Lynparza, AstraZeneca), niraparib (Zejula, GSK), and rucaparib (Rubraca, Clovis Oncology); the ATHENA-MONO, ENGOT-OV16/NOVA, SOLO2, and ARIEL3 clinical trials; and the implications of the “Dear Health Care Provider” letters that were issued earlier this year regarding PARP inhibitors.

A quartet of current clinical trials involving first-in-class molecules and CRISPR gene editing show great promise. STELLAR investigates a fusion protein in PAH, CodeBreak 200 studies a first-in-class of KRAS inhibitor, EMERGENT-2 focuses on a new treatment for schizophrenia, and NCT04601051 studies a gene editing drug for one form of amyloidosis.

Over a 4-year period, 500 patients were distributed equally between the two regimens. Two-year OS, relapse rates, and non-relapse mortality were similar between the two regiments, indicating that the busulfan regimen is non-inferior to the traditional TBI regimen.

The TRAILBLAZER-ALZ Randomized Clinical Trial According to the findings of post-hoc analysis for patients who received donanemab treatment, baseline amyloid levels were directly related to the extent of amyloid reduction and inversely related to the likelihood of obtaining total amyloid clearance. In patients with complete amyloid clearance and in brain areas discovered later in the pathologic sequence, the donanemab-induced slowing of tau was more severe. To support the aforementioned findings, data from additional trials would be crucial, particularly information on treatment response according to APOE ε4 status.