Alternative Endpoints in Phase III Trials Don’t Always Mean Boosts to OS, QOL
CHICAGO — Late-phase trials that showed superiority for an experimental intervention on a surrogate endpoint did not necessarily lead to improvements in overall survival (OS) or quality of life (QOL), according to a meta-epidemiologic analysis. Alexander Dean Sherry, MD of the MD Anderson Cancer Center in Houston, and colleagues evaluated 791 randomized controlled trials (RCTs) […]
Two Pembrolizumab Trials in Head and Neck Cancer Yield Divergent Results
Two first-line trials involving pembrolizumab (Keytruda)-based combinations for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) delivered mixed results. While first-line pembrolizumab plus lenvatinib (Lenvima) significantly improved progression-free survival (PFS) and overall response rate (ORR) compared with pembrolizumab alone in patients with recurrent or metastatic HNSCC with PD-L1 combined positive […]
Novel Therapies Show Early Promise in Advanced Gastroesophageal Cancers
Results of two early-phase trials offered a glimpse of promising new agents in the pipeline for advanced gastroesophageal cancer. In a phase II study, incorporating an investigational PD-1 inhibitor and anti-T-cell immunoglobulin and ITM domain (TIGIT) monoclonal antibody into standard first-line chemotherapy showed promising activity in advanced gastroesophageal adenocarcinoma, reported Yelena Janjigian, MD, from Memorial […]
Cognitive Dysfunction, Viral Persistence Studied First in New Long COVID Trials
The first two of the long-awaited long COVID clinical trials from the RECOVER initiative are underway, the NIH said. RECOVER-NEURO, which will study interventions for long COVID cognitive dysfunction, and RECOVER-VITAL, a study targeting viral persistence, are opening enrollment, said Acting NIH Director Lawrence Tabak, DDS, PhD, in a press briefing today. Two other trials, […]
Novel Anti-HER2 Drugs ‘Impressive’ in Advanced Biliary Cancer
CHICAGO — In a pair of mid-stage trials, newer targeted therapies demonstrated meaningful levels of activity against HER2-positive biliary tract cancers in pretreated patients with advanced disease. Cohort 1 of the global HERIZON-BTC-01 study, which included 80 treatment-refractory patients, showed that 41.3% (95% CI 30.4-52.8) responded to zanidatamab, an investigational bispecific monoclonal antibody that targets […]
Pragmatic Trials May Help Increase Minority Participation in MS Research
Pragmatic trials may offer one way to increase minority populations in multiple sclerosis (MS) studies, investigators for the DELIVER-MS trial suggested. Race and ethnicity did not appear to influence decisions to participate in either the randomized or observational cohorts of the pragmatic DELIVER-MS study, or in treatment choices, reported Sarah Planchon, PhD, of the Cleveland […]
Vitamin D Failed to Stop COVID, Other Respiratory Infections
Vitamin D supplements did not ward off COVID-19 or other respiratory infections, two randomized controlled trials showed. Among 6,200 participants in a phase III study from the U.K., 2.6% of those in the control group developed COVID-19 compared with 3.6% of those who received 800 IU vitamin D daily (OR 1.39, 95% CI 0.98-1.97) and […]
False Claims About COVID Vax Animal Testing Resurface
False claims that COVID-19 vaccine trials were halted when animals died in preclinical studies are making the rounds on social media again, according to reports. The misinformation gained traction in 2021 after Sen. Bob Hall (R-Texas) claimed at a hearing that the “American people are now guinea pigs.” A 1-minute clip of his remarks was […]
Lubricant Shots for Knee OA: No, They Really Don’t Help
Researchers analyzing previous trials of hyaluronic acid injections for knee osteoarthritis (OA) found that, although measurable benefit was demonstrated, it was too small to be clinically relevant. Pooled data from 24 large placebo-controlled studies comprising a total of 8,997 participants with knee OA indicated that, relative to placebo injections, hyaluronic acid reduced patients’ pain with […]
Placebo Responses in Migraine Prevention Trials Tick Upward Over Time
Placebo responses in migraine prevention trials appear to have risen over time, a systematic review and meta-analysis showed. A significant increase in placebo response was seen by publication year in migraine prevention studies that involved oral placebo (rho 0.39, P=0.047) but not in studies with injectable placebo (rho -0.07, P=0.724), reported Stewart Tepper, MD, of […]