Clinical Trial News

Dr. Chiara Ciccarese discusses the TACITO-II trial results on fecal microbiota transplantation (FMT) vs. placebo in metastatic renal cell carcinoma patients receiving pembrolizumab plus axitinib. FMT increased one-year progression-free survival (PFS) rate to 66.7% from 35%, meeting the primary endpoint. The procedure, performed via colonoscopy and oral capsules, was safe and feasible, with 90% dose intensity achieved. Future research will analyze microbiota composition and potential for phase III trials.

AstraZeneca's NIAGARA Phase III trial showed IMFINZI (durvalumab) plus chemotherapy improved event-free survival (EFS) and overall survival (OS) over neoadjuvant chemotherapy alone. The IMFINZI regimen reduced disease progression risk by 32% and death risk by 25%.

FDA approves Dupixent for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), expanding from initial approval for adults. Dupixent, a biologic inhibiting IL-4 and IL-13 pathways, demonstrated efficacy in trials, improving nasal congestion, polyp size, and sense of smell, while reducing corticosteroid use and surgery.

FDA approves EBGLYSS, a new biologic treatment for moderate-to-severe atopic dermatitis, offering significant skin clearance and itch relief within weeks, with long-lasting efficacy through monthly maintenance doses.

TORL-1-23, a CLDN6-targeted ADC, showed responses in heavily pretreated, CLDN6-positive advanced solid tumors, including platinum-resistant ovarian cancer, with a well-tolerated safety profile. The ORR was 26% at doses <2.4 mg/kg, 42% at 2.4 mg/kg, and 31% at 3.0 mg/kg, with a complete response rate of 4% at the highest dose. Neutropenia risk was mitigated by prophylactic pegfilgrastim, and the MTD was not yet reached.

LIBERTY-CUPID Study C confirms dupilumab's efficacy in reducing itch and disease activity in uncontrolled chronic spontaneous urticaria (CSU) patients. Dupilumab met primary and key secondary endpoints, with a 30% complete response rate in dupilumab-treated patients compared to 18% in the placebo group. Safety results were consistent with dupilumab's known profile, and Sanofi plans to share these data with the FDA to support an sBLA for CSU treatment.

AstraZeneca's Imfinzi in bladder cancer reduced death risk by 25%; Merck and Eisai's combo in liver cancer cut progression or death risk by a third; Bristol's lung cancer approach faced criticism for 'cherry-picking' subgroups.

Enzalutamide plus radium-223 significantly extends survival in men with castration-resistant prostate cancer and bone metastases, though with increased toxicity.

Cyramza plus Lonsurf did not significantly improve overall survival in heavily pretreated metastatic colorectal cancer patients compared to Lonsurf alone, according to the phase 3 IKF-AIO-RAMTAS trial. However, female patients and those with left-sided tumors showed potential benefit.

COVID vaccines have saved over 1.4 million lives in WHO's European region. SARS-CoV-2 continues to evolve, affecting immunity. Australia has updated vaccines four times, now considering a fifth targeting JN.1. JN.1 vaccines should protect against newer subvariants like FLiRT and FLuQE. Regulatory bodies like the FDA and TGA are evaluating JN.1 vaccines, with Moderna and Pfizer's Spikevax and Comirnaty under review in Australia. Safety and efficacy data show improved immune responses against newer variants. Novavax, a protein-based vaccine, offers an alternative for those unable to receive mRNA vaccines. Challenges include vaccine uptake and quicker approval processes.