Clinical Trial News

Novo Nordisk's CagriSema trial disappoints, causing $125B market value drop. Competition in weight-loss drug market intensifies with generic versions emerging. FDA approval of Vertex Pharma's cystic fibrosis treatment highlights pharmaceutical innovation.

Palbociclib + standard therapy improved progression-free survival in hormone receptor–positive, HER2-positive metastatic breast cancer. No significant overall survival benefit observed among CDK4/6 inhibitor combinations in hormone receptor-positive/HER2-negative breast cancer. Patritumab deruxtecan showed similar efficacy to multiagent chemotherapy in high-risk hormone receptor-positive, HER2-negative breast cancer. Ciltacabtagene autoleucel achieved 100% complete response in high-risk smoldering multiple myeloma. Selinexor + ruxolitinib showed efficacy in myelofibrosis patients previously treated with ruxolitinib.

FDA approves Zepbound, first medication for moderate to severe obstructive sleep apnea in obese adults, to be used with diet and exercise. Zepbound, also known as Mounjaro, reduces appetite and improves OSA by reducing body weight, with significant reduction in apnea/hypopnea events and weight loss in studies.

Targeted therapies for metastatic colorectal cancer (mCRC) are moving to earlier treatment lines, emphasizing the importance of molecular testing. Key options include anti-EGFR therapy for RAS wild-type patients, BRAF V600E inhibitors like encorafenib, and HER2-directed therapies such as trastuzumab plus tucatinib. Ongoing trials aim to integrate these therapies into first-line settings, including MOUNTAINEER-03 for HER2-positive patients and studies on new RAS-targeted therapies.

Researchers identified three osteosarcoma subtypes using Latent Process Decomposition, potentially transforming clinical trials and patient care. This method considers tumor heterogeneity, revealing subtypes with varied responses to standard chemotherapy, enabling more targeted treatments.

The FDA approved Eli Lilly's Zepbound (tirzepatide) for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity, based on SURMOUNT-OSA trials showing significant reductions in apnea-hypopnea index (AHI) and substantial weight loss. Zepbound, which reduces appetite and food intake, offers a new non-invasive treatment option for OSA, a condition affecting 30 million Americans but significantly underdiagnosed. Common side effects include gastrointestinal issues, and patients with a history of medullary thyroid carcinoma should avoid the drug.

This study investigates the implementation of SPARCK, a parent training intervention, in a hybrid effectiveness-implementation trial. It examines the relations between implementation determinants and outcomes, and their impact on clinical outcomes. The study uses a longitudinal design, collecting data from practitioners and leaders over three time points, and employs multilevel models for analysis.

FDA approves Eli Lilly's Zepbound for obesity and moderate-to-severe obstructive sleep apnea, marking the first drug treatment for OSA. Zepbound should be used with a reduced-calorie diet and increased physical activity. Approval may impact insurance coverage, giving Eli Lilly an edge over Novo Nordisk. Clinical trials showed nearly half of patients experienced disease resolution.

RH5.1/Matrix-M, a blood-stage malaria vaccine, shows promising results in Phase IIb trial, potentially becoming the first of its kind. It complements pre-erythrocytic vaccines, offering a second line of defence against malaria, with 55% efficacy against clinical malaria and 80% in reducing high parasite levels. The vaccine targets the blood stage, occurring after liver infection, and could significantly aid global malaria prevention efforts.

Novo Nordisk shares fell 22% after a weight-loss drug study showed Cagrisema users lost 22.7% vs. 2.3% with a placebo, below the expected 25%. Despite this, the company plans to explore Cagrisema's potential further.