Clinical Trial News

Electroacupuncture added to standard antiemetic therapy significantly increased complete protection from chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients receiving highly emetogenic chemotherapy, with a higher rate of complete protection during the delayed stage.

The phase 3 ECHELON-3 study showed that adding brentuximab vedotin to lenalidomide and rituximab significantly improved overall survival (OS), progression-free survival (PFS), and objective response rates (ORR) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who had received at least 2 prior lines of therapy. The triplet regimen resulted in a 47% reduction in the risk of disease progression or death and an ORR of 64.3% vs 41.5% with the doublet. The benefits were consistent across key subgroups, with manageable safety profiles.

Study approved by Fudan University Shanghai Cancer Center (NCT04461990). FUSCC, DUKE, and I-SPY1 cohorts analyzed for breast cancer prognosis and treatment response using DCE-MRI and multiomic data. FUSCC cohort included 466 participants with prognosis information, DUKE 619, and I-SPY1 128. Primary endpoints were relapse-free survival (RFS) and pathological complete response (pCR). Radiomic features extracted and analyzed for prognostic and treatment response prediction.

Maxim Group's Jason McCarthy maintains Buy rating on Unicycive Therapeutics (UNCY) due to the NDA submission for OLC, potential cost savings, and favorable study results. Despite price target reduction due to TDAPA uncertainties, OLC's approval could unlock significant revenue. UNCY's stock has dropped 76.86% over six months.

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Preliminary findings from the phase 1b CC-220-DLBCL-001 trial show that combining golcadomide (0.4 mg) with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) is well-tolerated and yields high metabolic response rates in previously untreated aggressive B-cell lymphoma patients. The 0.4-mg dose achieved an 88% complete metabolic response rate, with promising 12-month progression-free survival in both overall and high-risk groups. Golcadomide, a first-in-class oral CELMoD agent, demonstrated a toxicity profile similar to R-CHOP and maintained good dose intensity.

Health Ministry approves BPaLM regimen, a shorter, more effective treatment for MDR-TB, consisting of Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin, curing drug-resistant TB in six months with high success rates and cost savings.

Intelligent Bio Solutions (INBS) announces progress in its clinical study plan, aiming for FDA 510(k) submission for non-invasive drug screening tech by late 2024. The company is conducting a method comparison study with CenExel, comparing fingerprint sweat opiate screening with LC-MS/MS methods, with completion targeted for September. The technology promises quick, hygienic, and accurate drug screening.

The study developed parametric drug–disease models using pooled clinical trial data to estimate patient-/disease-related factors and drug-specific properties, then explored how baseline characteristics influence treatment performance. Key findings include: higher baseline ACQ-5 scores linked to poorer asthma control and higher exacerbation risk; male non-smokers with BMI < 25 kg/m² and no recent exacerbations had lower risk compared to female smokers with BMI ≥ 25 kg/m² and prior exacerbations; smokers used more reliever medication; ACQ-5, BMI, and smoking status influenced immediate symptoms and exacerbation risk; FF/VI treatment showed lower exacerbation risk and higher reduction in reliever use compared to BUD/FOR; model-based approach distinguished patient-/disease-specific features from drug-specific properties; simulation scenarios indicated stepping up to FF/VI combination therapy could significantly reduce exacerbation risk; personalized management should consider factors like high BMI, low FEV1, exacerbation history, and female sex.

FDA official clarifies cGMP expectations for investigational drugs.