Clinical Trial News

Precede Biosciences presented data at the 2024 ESMO Annual Meeting demonstrating their epigenomic liquid biopsy platform's ability to assess tumor PSMA expression from blood, aiding in patient identification for PSMA-targeting therapies.

Preoperative chemoradiotherapy did not improve survival over perioperative chemotherapy alone in resectable gastric and gastroesophageal junction adenocarcinoma, according to TOPGEAR data. Median overall survival was 46.4 months vs 49.4 months, with no significant differences in progression-free survival. However, preoperative chemoradiotherapy significantly improved pathological outcomes, including complete response rates and tumor downstaging.

NICHE-3 study, approved by NedMec, enrolled adults with dMMR resectable colon adenocarcinoma. Patients received nivolumab and relatlimab, followed by surgery. Primary endpoint was pathologic response (≤50% RVT), with secondary endpoints including safety and survival. Study used a Simon’s two-stage design, aiming for a response rate of 85%. Pathologic response was assessed by central histopathologic review. Safety and efficacy populations were defined, with binary endpoints reported as proportions. MMR status was assessed via immunohistochemistry.

23ME-00610, an anti-CD200R1 antibody, shows preliminary clinical benefit in clear-cell renal-cell carcinoma with one confirmed partial response. Higher CD200 tumor expression and human genetics correlate with increased clinical benefit, suggesting potential as patient selection biomarkers. Greater response in 'cold' tumors indicates opportunity for patients unresponsive to PD-1/PD-L1 inhibitors.

Dupilumab, a new drug for COPD, significantly reduces symptoms and improves lung function, awaiting NHS approval.

Durga Borkar, MD, discusses phase 2 clinical trial results for ONL-1204, a novel agent for rhegmatogenous retinal detachment, showing visual benefits for high-risk patients. The study involved intravitreal injections and surgical repair, with plans for subgroup analyses and FDA meetings.

City of Hope Hospital developed AOH1996, a cancer drug targeting PCNA, showing promise in lab tests against 70 cancer cell lines. Named after a childhood cancer victim, it's now in Phase 1 clinical trials for solid tumour treatment.

Dr. Begona Perez-Valderrama discussed novel agents and combinations in RCC and urothelial carcinoma at the 2024 ESMO meeting, highlighting belzutifan's potential in RCC therapy and ongoing trials assessing various combinations, including antibody-drug conjugates like disitamab vedotin and trastuzumab deruxtecan.

Eric Jonasch, MD, discusses the potential implications and next steps for the investigational HIF-2α inhibitor NKT2152, which showed strong anti-tumor activity in advanced clear cell renal cell carcinoma patients, based on findings from a phase 1/2 study presented at the 2024 ESMO Congress. Jonasch highlights the need for a registrational strategy and further research on patient response and combination therapies.

A study of biosimilar infliximab-dyyb (CT-P13) in RA found stable disease activity in patients switching from the reference product or another infliximab biosimilar, and improvement in those switching from non-infliximab biologics or tsDMARDs. 68% of patients remained on CT-P13 at 6 months, with 32.9% achieving low disease activity. The study suggests real-world outcomes are comparable to clinical trial efficacy.