Clinical Trial News

Remote clinical trials in the U.S. have grown significantly, particularly in oncology and cardiology, leveraging telemedicine and remote monitoring for patient-centric trials. This approach enhances patient recruitment, retention, and real-time data collection, benefiting intensive treatments like cancer and continuous monitoring needs in heart conditions.

Recent FDA approval of guselkumab (Tremfya) for UC and other advancements in IBD treatment offer more options, prompting reevaluation of CD and UC management. Andrea Banty, NP, DNP, emphasizes the importance of aligning patient goals with treatment options, considering administration preferences and safety risks.

Oncologica, developer of a urine-based prostate cancer screening test, seeks £6 million to fund clinical trials and regulatory approval, aiming to improve early detection and patient outcomes.

Retifanlimab with carboplatin and paclitaxel showed significant progression-free survival vs placebo in metastatic SCAC patients, with a median PFS of 9.3 months vs 7.4 months (HR, 0.63; P = .0006). Retifanlimab also improved overall response rate and overall survival.

Radium-223 plus enzalutamide significantly improved radiological progression-free survival (rPFS) and overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) patients with bone metastases, according to PEACE-3 trial data. The combination also extended time to next systemic treatment (TTNT) but did not affect time to pain progression or first symptomatic skeletal event (SSE). Use of a bone-protecting agent was mandatory. Safety data showed higher rates of adverse events in the combination arm, with no drug-related deaths.

Zanidatamab (ZW25) plus mFOLFOX6-2 with or without bevacizumab showed 83.3% and 100% confirmed overall response rates, respectively, in a phase 2 study for HER2-positive mCRC, with manageable safety profile and no treatment-related deaths.

GLP-1 agonists like semaglutide, originally for diabetes, show promise in weight loss and reducing cardiovascular mortality, heart attacks, and strokes in non-diabetic obese individuals. The SELECT trial found a 19% reduction in these events with semaglutide, but early death reduction and COVID-19 mortality effects raise questions. Baseline differences in loop diuretic use suggest more advanced heart disease in deceased participants, potentially skewing results.

Zipalertinib demonstrated promising efficacy and a manageable safety profile in heavily pretreated NSCLC patients with EGFR exon 20 insertion mutations who progressed on amivantamab, with an ORR of 40% in the overall population and 50% in the prior amivantamab-only population, according to data from the phase 2b REZILIENT1 trial presented at ESMO Congress 2024.

Adjuvant pembrolizumab plus chemotherapy did not improve DFS in high-risk endometrial cancer patients overall, but showed a clinically meaningful benefit in those with dMMR tumors. The 2-year DFS rates were 92% with pembrolizumab vs. 80% with placebo in the dMMR subgroup, while rates were 69% vs. 75% in the pMMR subgroup. Safety profiles were consistent with known checkpoint inhibitors, with no treatment-related deaths.

GALAXY study data shows Signatera predicts colorectal cancer survival, with a 10x advantage at 36 months for ctDNA-negative patients and a 50% reduced risk of death for Signatera-positive patients on adjuvant chemotherapy.