Lyell Immunopharma has begun its PiNACLE – H2H Phase III trial evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtageneciloleucel (axi-cel). The CAR-T therapies will be assessed in relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the second-line… Read More
Corcept Therapeutics has announced that ROSELLA, the company’s Phase III trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, met its overall survival primary endpoint. In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 35% reduction in the risk of… Read More
Lilly’s Taltz (ixekizumab) and Zepbound (tirzepatide) used together have been shown to deliver superior efficacy in first-of-its-kind Phase IIIb trial for adults with active psoriatic arthritis (PsA) and obesity or who are overweight. At 36 weeks, treatment with concomitant Taltz and Zepbound met the primary and all… Read More
Takeda’s oral tyrosine kinase 2 (TYK2) inhibitor zasocitinib (TAK-279) has shown promise to deliver clear skin in a once-daily pill. Phase III studies in adults with moderate-to-severe plaque psoriasis (PsO) have demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints, static Physician Global Assessment (sPGA)… Read More
Lilly’s orforglipron has helped people maintain weight loss after switching from injectable incretins to oral GLP-1 therapy in first-of-its-kind Phase III trial. The ATTAIN-MAINTAIN trial evaluated orforglipron, a once-daily oral glucagon-like peptide-1 (GLP-1) receptor agonist, for weight maintenance over 52 weeks after initial treatment for 72 weeks… Read More
Global biopharmaceutical company UCB has reported positive data for its Phase III GEMZ study which is investigating adjunctive fenfluramine in children and adults with CDKL5 Deficiency Disorder (CDD). The data were announced at the American Epilepsy Society (AES) meeting, Atlanta, USA. The results… Read More
Eisai and Merck (MSD outside of the US and Canada) have announced that in a Phase III trial, Lenvima (lenvatinib) plus Keytruda (pembrolizumab) with transarterial chemoembolisation (TACE) did not achieve statistical significance for overall survival (OS) compared to TACE alone. The LEAP-012 trial evaluated the combination in… Read More
Intellia Therapeutics announced it has temporarily paused its MAGNITUDE and MAGNITUDE-2 Phase III clinical trials of nex-z for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN), respectively. The action follows a report of Grade 4 liver transaminases and increased total bilirubin in a patient who… Read More
In the Phase III DREAMS-3 clinical trial of mazdutide, the glucagon-like peptide-1 (GLP-1) and glucagon (GCG) dual receptor agonist showed superior efficacy to semaglutide for body weight reduction. In Chinese patients with type 2 diabetes (T2D) and obesity, mazdutide performed better than semaglutide on the primary endpoint,… Read More
Alector has revealed that in a Phase III clinical trial in individuals with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN) its candidate latozinemab (AL001) did not meet the clinical co-primary endpoint. Based on the results, the company has announced that the open-label extension portion of… Read More
Acadia Pharmaceuticals has announced that its Phase III COMPASS PWS trial evaluating intranasal carbetocin (ACP-101) in patients with hyperphagia in Prader-Willi syndrome (PWS) did not meet its primary endpoint. The treatment did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, change from… Read More
Roche has shared new data from its Alzheimer’s development portfolio at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada. Featured oral presentations include the latest results from the ongoing Phase Ib/IIa Brainshuttle Alzheimer’s disease (AD) study and design of the Phase III TRONTIER 1 and 2… Read More
High-level results from the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme show that anselamimab did not achieve statistical significance for the primary endpoint compared to placebo in patients with Mayo stages IIIa and IIIb light chain (AL) amyloidosis. The primary endpoint was defined… Read More
Gilead Sciences will share new Phase III trial data showing that twice-yearly lenacapavir (Yeztugo) was effective and well tolerated among a broad range of populations who need or want pre-exposure prophylaxis (PrEP) for HIV prevention. The new data, from the company’s pivotal Phase III PURPOSE 1 and… Read More
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for previously untreated mantle cell lymphoma (MCL). It is approved in patients who are not eligible for autologous stem cell transplant. The approval by the European Commission was… Read More
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. With Eli Lilly so far winning the race to bring an oral GLP-1 drug… Read More
