Davy James

Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.

Phase III HELIOS-B trial found that Amvuttra (vutrisiran) also preserved functional capacity and quality of life in patients with transthyretin amyloidosis with cardiomyopathy.

Semaglutide 7.2 mg significantly outperformed semaglutide 2.4 mg and placebo with a 20.7% average reduction in weight and a comparable safety and tolerability profile, further establishing its efficacy in obesity treatment.

An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.

Pilot trial shows that a user-friendly electronic patient-reported outcome (ePRO) monitoring system significantly improves patient-centered cardiovascular care by enhancing patient-physician communication, increasing clarity in treatment explanations, and empowering patients with better knowledge of their conditions.

Results from the TROPION-Lung05 and TROPION-Lung01 clinical trials show the promise of datopotamab deruxtecan, a novel TROP2-directed antibody-drug conjugate, for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

Phase III IRAKLIA trial shows that subcutaneous Sarclisa delivered via an on-body delivery system is as effective and safe as intravenous administration in treating relapsed or refractory multiple myeloma.

A Phase Ib/II dose escalation and expansion trial shows promising antitumor activity and durable responses with Talvey (talquetamab) plus Tecvayli (teclistamab) in the treatment of relapsed or refractory multiple myeloma, but a higher incidence of grade 3 or 4 infections.

Study finds the typical cost of clinical research for developing new drugs is lower than previously estimated, with median costs providing a more accurate reflection than mean costs.

Results from the Phase III MARIPOSA trial demonstrated the combination of Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) significantly improves overall survival compared to the current standard of care, Tagrisso (osimertinib), for patients with EGFR-mutated advanced or metastatic non-small cell lung cancer.

Study finds that addressing racial disparities in lupus clinical trials requires targeted education, increased diversity among trial staff, culturally sensitive recruitment strategies, and addressing social determinants of health to improve Black patient participation.

Study finds that existing patient-reported outcome (PRO) measures fail to fully capture health-related quality-of-life for some conditions, highlighting the need for a novel, disease-specific PRO to better assess treatment efficacy and improve patient care in clinical trials.

Phase III trial shows the combination of brexpiprazole plus sertraline significantly improved the symptoms of post-traumatic stress disorder compared to sertraline plus placebo, with a tolerable safety profile and low discontinuation rates.

Prasinezumab did not achieve statistical significance for its primary endpoint in the Phase IIb PADOVA trial for early-stage Parkinson's disease, but showed potential clinical efficacy with positive trends in motor progression and secondary outcomes.

Depemokimab, an ultra-long-acting anti–IL-5 biologic therapy, significantly reduced annual asthma exacerbations in patients with severe eosinophilic asthma while maintaining a favorable safety profile, offering the potential for improved patient quality of life with reduced dosing frequency.

Results from the EMBER-3 trial show imlunestrant, both as monotherapy and in combination with Verzenio (abemaciclib), significantly improved progression-free survival in ESR1-mutated ER-positive, HER2-negative advanced breast cancer.

Data from the OlympiA Phase III trial show Lynparza (olaparib) significantly improved the risk of death, invasive disease-free survival, and distant disease-free survival over six years in patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Results from the DREAMM-7 Phase III trial demonstrated that Blenrep (belantamab mafodotin) combined with bortezomib and dexamethasone significantly improved overall survival, progression-free survival, and treatment response in relapsed or refractory multiple myeloma compared to a daratumumab-based regimen.

Phase III CARTITUDE-4 trial shows Carvykti significantly improves minimal residual disease negativity rates, progression-free survival, and overall survival compared to standard therapies for patients with relapsed or refractory multiple myeloma, especially when used earlier in treatment.

The Phase III AALL1731 trial demonstrated that adding Blincyto (blinatumomab) to chemotherapy significantly improved three-year disease-free survival in pediatric patients with standard-risk B-cell acute lymphoblastic leukemia.

Merck and Ridgeback Biotherapeutics have launched the Phase III MOVe-NOW trial to evaluate a new, streamlined formulation of Lagevrio (molnupiravir) for treating non-hospitalized COVID-19 patients at high risk of severe disease progression who are unable to use other antiviral therapies.

Phase II Piranga trial found that the combination of xalnesiran and an immunomodulator effectively reduced hepatitis B surface antigen (HBsAg) levels, but highlighted challenges in response durability and efficacy in patients with high HBsAg levels.

Publicly funded non-inferiority trials have grown in popularity with high levels of non-inferiority margin reporting; however, a recent analysis notes a need for improved design and reporting practices to ensure clinical relevance and reliability.

CAR T-cell therapy obecabtagene autoleucel produced high response rates, durable outcomes, and low toxicity in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, especially benefiting those with low-to-intermediate bone marrow burden.

Phase III CheckMate 8HW trial results demonstrated that the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improves progression-free survival and has a better safety profile compared to chemotherapy in the first-line treatment of MSI-H or dMMR metastatic colorectal cancer.

Results from a followup evaluation of COLOFOL trial show no significant improvement in 10-year overall or colorectal cancer–specific mortality rates between high-frequency and low-frequency postoperative follow-up regimens for patients with stage II or III colorectal cancer.

The Phase II KRAKEN trial demonstrated that muvalaplin, Eli Lilly's first-in-class oral small molecule inhibitor, significantly reduces lipoprotein(a) levels with minimal adverse effects, offering a promising new approach to addressing a major cardiovascular risk factor.

Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.

The Phase III CLEAR SYNERGY trial found that long-term colchicine treatment after acute myocardial infarction does not reduce major cardiovascular events compared to placebo, highlighting mixed results from prior studies on its efficacy in cardiovascular disease.

The Phase III SUMMIT trial showed that tirzepatide significantly reduces the risk of worsening heart failure events or death from cardiovascular causes, enhances physical function, and leads to weight loss and reduced inflammation in patients with heart failure with preserved ejection fraction.