ND-346 / Nimbus Therap, Roche - LARVOL DELTA

The predictive value of mosaic chromosomal alterations for lymphoid malignancies varies by monoclonal B-cell lymphocytosis status (ASH 2025) - "Flow cytometry identified 3,231 individuals who screened negative for MBL, 754 individuals withlow-count MBL, and 346 individuals with high-count MBL...In high-count MBL, mCAswere also a biomarker, but were driven by known chromosomal abnormalities identified through clinicaltesting. These findings suggest that the utility of mCAs as a predictive marker for lymphoid malignancy iscontingent on the presence of MBL and may inform risk stratification and surveillance strategies in thispopulation."

Tumor mutational burden • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD5

Vericiguat in patients with chronic heart failure and reduced ejection fraction (VICTOR): a double-blind, placebo-controlled, randomised, phase 3 trial. (PubMed, Lancet) - P3 | "Among patients with HFrEF and no recent worsening, vericiguat did not reduce the risk of a composite endpoint of time to cardiovascular death or heart failure hospitalisation. Fewer cardiovascular deaths were observed in the vericiguat group than in the placebo group."

Journal • P3 data • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypotension

Vericiguat and mortality in heart failure and reduced ejection fraction: the VICTOR trial. (PubMed, Eur Heart J) - P3 | "In ambulatory well-treated participants with HFrEF, vericiguat was associated with clinically meaningful reductions in the key secondary outcome of cardiovascular death, as well as all-cause mortality."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Corticosteroid Injections and Risk of Fracture. (PubMed, JAMA Netw Open) - "A total of 7197 patients were included in the study (mean [SD] age, 64.4 [14.6] years; 4435 [61.6%] women; 183 [2.5%] Black and 6667 [92.6%] White), and 346 (4.8%) had a new fracture during the study period...In this cohort study of cumulative injected corticosteroid dose and risk of subsequent fracture, no association was observed, including in patients with a preexisting diagnosis of osteoporosis. Treatment of painful conditions with CSI should not be withheld or delayed owing to concern about fracture risk."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pain • Rheumatology

Atezolizumab plus chemotherapy versus placebo plus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis results from a randomised, controlled, phase 3 study. (PubMed, Lancet Oncol) - P3 | "Progression-free survival benefit with first-line combination of atezolizumab plus platinum-based chemotherapy did not translate into a significant improvement in overall survival in the ITT population of IMvigor130. Further research is needed to understand which patients might benefit from first-line combination treatment. No new safety signals were observed."

Journal • Metastases • P3 data • Acute Kidney Injury • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Hepatology • Infectious Disease • Liver Failure • Nephrology • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • Septic Shock • Solid Tumor • Thrombocytopenia • Urothelial Cancer • PD-L1

BK polyomavirus DNAemia in pancreas transplant recipients compared to pancreas-kidney recipients. (PubMed, Clin Transplant) - "BKV DNAemia was common among PTA recipients, though lower than a comparable group of pancreas-kidney recipients. However, BKV DNAemia was not associated with adverse native kidney outcomes and no PTA recipients developed endstage kidney disease. Conversely, BKV DNAemia was associated with pancreas allograft failure. Further studies are needed to estimate the rate of BKV nephropathy in this population, and further evaluate long-term kidney outcomes."

Journal • Retrospective data • Chronic Kidney Disease • Gastrointestinal Disorder • Hepatology • Infectious Disease • Nephrology • Transplantation

Risk Factors for Early Post-Solid Organ Transplant Fungal Disease: A Systematic Review and Meta-Analysis [Board No. D101] (ATC 2023) - "There was a total of 19,618 SOT recipients included (7,578 liver, 2,044 lung, 6,427 kidney, 3,223 heart, and 346 pancreas-kidney transplant recipients)... This systematic review and meta-analysis has identified several important risk factors for IFI within the first year following SOT. Transplant recipients with these risk factors may benefit more than other recipients from pharmacologic preventative measures."

Retrospective data • Review • Diabetes • Infectious Disease • Metabolic Disorders • Solid Organ Transplantation • Transplantation

Physiology-Enhanced Data Analytics to Evaluate the Effect of Altitude on Intraocular Pressure and Ocular Hemodynamics. (PubMed, Photonics) - "In the MBS, IOP and BP were measured in 33 healthy volunteers at 77 and 3466 m above sea level...Pe-aqueous humor analysis showed that a decrease in osmotic pressure difference (OPD) may underlie the difference in IOP measured at different altitudes in the MBS. Our analysis suggests that venules bear the significant portion of the IOP pressure load within the ocular vasculature, and that OPD plays an important role in regulating IOP with changes in altitude."

Journal • Glaucoma • Ophthalmology

Efficacy, safety, and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma (ACOUSTICS). (PubMed, Clin Transl Allergy) - P3 | "Between August 2013 and July 2016, 579 patients were screened and 346 were randomised; 224 (65%) completed the study with 52 weeks of treatment. However, the study was prematurely terminated (sponsor's decision) potentially limiting interpretation of results. NCT01875003 (www.ClinicalTrials.gov)."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL13

Clinical Reasoning: A 31-Year-Old Man With Sequential Vision Loss. (PubMed, Neurology) - "Eventually, mitochondrial whole genome sequencing was performed, which demonstrated a mutation at the 13513G>A position confirming the diagnosis of LHON. Three primary mutations (11778G>A, 14484T>C and 3460G>A) account for 90% of LHON cases, therefore it is important to consider whole genome mitochondrial sequencing in cases with a high index of clinical suspicion."

Clinical • Journal • Inherited Retinal Dystrophy • Leber Hereditary Optic Neuropathy • Ocular Inflammation • Ophthalmology • Optic Neuritis