Articles related to CLINICAL TRIALS

In this multinational, phase 3, head-to-head trial (ALPINE), patients who received zanubrutinib — a Bruton’s tyrosine kinase (BTK) inhibitor with greater specificity– rather than the BTK inhibitor ibrutinib, had significantly longer progression-free survival in individuals with relapsed or refractory CLL or SLL, and zanubrutinib was linked to fewer cardiac side events.

In this single-group, phase 1-2 trial, sotorasib (LUMAKRAS, Amgen) demonstrated antitumor effect in patients with KRAS p.G12C-mutated advanced pancreatic cancer who had undergone prior therapy and had an acceptable safety profile.

In this phase 3 double-blind, randomized, 72-week controlled trial of 2,539 adults with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body weight.

Given the global shortage of nirmatrelvir–ritonavir for COVID, alternative antivirals are in demand. This phase 3 randomized trial compared VV116 to nirmatrelvir–ritonavir for adults with mild-to-moderate COVID-19 at risk for progression. The trial was conducted during Omicron strain prevalence (B.1.1.529). Time to clinical recovery was 4 days with VV116 versus 5 days with nirmatrelvir–ritonavir. AEs were seen in 67.4% and 77.3% of the VV116 nirmatrelvir–ritonavir groups, respectively.

The researchers tested whether a ctDNA-guided strategy could lower the need for adjuvant chemotherapy without increasing the risk of recurrence. Recurrence-free survival at 2 years was the main efficacy end objective. Adjuvant chemotherapy usage was a significant secondary end goal.

In this trial, disease-free survival was longer with adjuvant nivolumab than with placebo in the intention-to-treat population and among patients with a PD-L1 expression level of 1% or more in patients with high-risk muscle-invasive urothelial carcinoma who had had radical surgery.