Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.In the phase 3 THOR trial, Balversa cut the risk of death by 36% to accomplish its primary objective. It helped extend lives by an average of 12.1 months versus a 7.8-month average for patients on chemotherapy. The interim results were from cohort 1 of the confirmatory study and were presented Monday at the American Society of Clinical Oncology’s (ASCO’s) annual meeting in Chicago. “The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer,” Yohann Loriot, M.D., Ph.D., of the University of Paris-Saclay in France and the principal study investigator, said in a release. Balversa was approved on an accelerated basis in 2019, becoming the first ...
SHANGHAI, May 28, 2023 /PRNewswire/ — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that the updated results of Phase Ib study of its CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor (“TGCT”), will be released at the 2023 American Society of Clinical Oncology (“ASCO”) annual meeting to be held in Chicago, USA from June 2 to June 6, 2023. The data demonstrates the excellent antitumor efficacy and the safety profile of Pimicotinib in the treatment of patients with advanced TGCT and will be presented with the title of “EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATE” in a poster presentation with the poster Bd# of “493”. Among the data released by Abbisko, the most remarkable result is the objective response rate (ORR) of the 50 mg QD dose group of Pimicotinib (ABSK021), which reached 77.4% ...
French medical bodies on Sunday called on authorities to punish researcher Didier Raoult for “the largest ‘unauthorized’ clinical trial ever seen” into the use of hydroxychloroquine to treat COVID-19. Raoult, the former head of the IHU Mediterranee research hospital, and his subordinates engaged in “systematic prescription of medications as varied as hydroxychloroquine, zinc, ivermectin and azithromycin to patients suffering from COVID-19… without a solid pharmacological basis and lacking any proof of their effectiveness,” a group of 16 research bodies wrote in an op-ed piece on daily Le Monde’s website. The drugs continued to be prescribed “for more than a year after their ineffectiveness had been absolutely demonstrated,” they added. Endorsement from respected tropical disease specialist Raoult helped push anti-malaria drug hydroxychloroquine into the public consciousness in the early days of the coronavirus pandemic, feeding into its promotion by former US President Donald Trump and Brazil’s then-leader Jair Bolosonaro. In April, ...
CAR-T therapies have been around for six years, but it was only in January that Bristol Myers Squibb unveiled the first positive readout for such a personalized immunotherapy in chronic lymphocytic leukemia (CLL), the most common form of leukemia, from a pivotal multicenter study. In new data released Thursday, Bristol Myers Squibb said that Breyanzi eradicated signs of cancer in 18.4% of patients with heavily pretreated CLL or small lymphocytic lymphoma (SLL). The phase 1/2 trial coded TRANSCEND CLL 004 has therefore met its primary endpoint. Among those who achieved a complete response, the median duration of response wasn’t reached after a median follow-up of 21.1 months. No patients in that group experienced disease progression or deaths by the data cutoff. The results will be presented during the 2023 American Society of Clinical Oncology annual meeting on June 6. Bristol released the findings ahead of the meeting Thursday. Breyanzi’s complete response data “are remarkable and ...
By Kate Goodwin https://www.biospace.com/ Pictured: Blue Roche logo on white building/Smith Collection/Gado/Getty Images Roche has terminated a second Phase II trial of its investigational schizophrenia drug ralmitaront, leaving an uncertain future for the company’s program targeting the psychiatric disorder. The first trial, which was canceled last year, was studying the effects of ralmitaront as a monotherapy in patients with an acute exacerbation of positive symptoms of schizophrenia or schizoaffective disorder. The second trial, which was recently terminated, was investigating the impact of the treatment on negative symptoms associated with the two conditions. “In a preliminary analysis, the primary endpoint was negative, and ongoing portions of the study have therefore been discontinued,” according to an update on the second Phase II trial posted to the ClinicalTrials.gov website. Roche’s latest first quarter 2023 pipeline presentation included the asset, pushing its New Molecular Entity submission back into the “2026 and beyond” category. No ...
Transthyretin-related cardiac amyloidosis is a progressive disease characterized by the deposition of amyloid protein fibrils in the heart. Amyloid fibril deposition thickens and stiffens the heart walls, and the disease is also known as stiff-heart syndrome. The accumulation of amyloid fibrils causes heart failure, and patients suffer from fluid retention, fatigue, and arrhythmias. The disease can be caused by genetic mutations or related to aging. Prognosis is poor, and untreated patients survive for an average of just 3 years. Now, the results of a study published in the The New England Journal of Medicine (NEJM) promise to radically alter the prospects of patients with this disease. The study was led by Dr. Pablo Garcia-Pavía, who heads the Inherited Cardiac Diseases Section at Hospital Universitario Puerta de Hierro and is a research scientist at the Centro Nacional de Investigaciones Cardiovasculares (CNIC) and within the Spanish cardiovascular research network (CIBERCV). Coinciding with ...
Eli Lilly’s experimental Alzheimer’s drug, donanemab, has been shown to significantly slow cognitive and functional decline in patients with early-stage disease. The phase 3 TRAILBLAZER-ALZ 2 study met its primary endpoint, with the drug slowing the progression of the disease by 35% compared to placebo in 1,182 patients with early symptomatic Alzheimer’s disease and intermediate levels of tau protein. All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits, the company said. Results from the trial demonstrated that 47% of patients who received donanemab showed no disease progression a year after starting treatment, compared with 29% on placebo. Additionally, 52% of patients completed their course of treatment by one year, and 72% completed by 18 months as a result of achieving amyloid plaque clearance. Patients receiving donanemab also experienced a 39% lower risk of progressing to the next stage of disease, and ...
Daniel M. Keller, PhD Among patients with atrial fibrillation (AF), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows. Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications. Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen Hospital, Shenzhen, China, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AF. “The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said. The results were presented in a moderated poster session at the European Heart Rhythm Association (EHRA) 2023 in Barcelona and are available online. Widely Prescribed Anticoagulant ...
A successful gene therapy trialed at Michigan State University in dogs with an inherited eye disease is ready to be developed for clinical use in human patients with a rare condition called retinitis pigmentosa. Simon Petersen-Jones, professor and Donald R. Meyers and William E. Dunlap Endowed Chair in Canine Health at the Michigan State College of Veterinary Medicine, and his collaborators have published “Development of a translatable gene augmentation therapy for CNGB1-Retinitis Pigmentosa” in Molecular Therapy. Retinitis pigmentosa encompasses a group of rare genetic diseases that cause vision loss due to death of the light-sensing cells in the retina. Vision loss begins at a young age, and progresses throughout the lifespan. “There is currently an unmet need for treatment to save the vision of patients with CNGB1-retinitis pigmentosa,” Petersen-Jones said. “This promising therapy that works so well in dogs is now sufficiently developed that the next step is to take it forward for ...
The stakes are getting even higher for the fight between Eli Lilly and Novo Nordisk for supremacy in the multibillion-dollar obesity market. Lilly on Friday quietly registered a new phase 3b trial on clinicaltrials.gov. The study, coded SURMOUNT-5, will pit Lilly’s Mounjaro against Novo’s Wegovy in patients with obesity or overweight with weight-related health conditions. The trial aims to enroll 700 participants from 61 sites in the U.S., Canada, South America and several European countries, according to the post. The study is currently expected to officially start next Friday and last for about 78 weeks, with an estimated primary completion date in February 2025. On the study’s primary endpoint, investigators will compare the percentage weight changes between the two drugs by week 72 from baseline. However, it’s not immediately clear whether Lilly is designing SURMOUNT-5 as a superiority study to show Mounjaro is better than Wegovy or just to show ...
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