Tag: Clinical Data

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Lilly’s Jaypirca Outperforms Imbruvica in Landmark Phase 3 Trial for CLL/SLL

Eli Lilly and Company

Eli Lilly announced that its non-covalent BTK inhibitor, Jaypirca (pirtobrutinib), met the primary endpoint of non-inferiority on Overall Response Rate (ORR) when compared to Imbruvica (ibrutinib) in the landmark BRUIN CLL-314 Phase 3 trial. The drug demonstrated numerically higher efficacy (87.0% ORR) and a significant safety advantage, including much lower rates of atrial fibrillation/flutter and hypertension, positioning Jaypirca as a potential new front-line therapy for CLL/SLL.

Clinical Trials Healthcare & Pharmaceuticals News

Eli Lilly Announces Positive Results from Two Phase 3 Studies of Jaypirca at ASH 2025

Eli Lilly and Company

Eli Lilly and Company is set to present “striking” new data at the 2025 ASH Annual Meeting, revealing a double victory for its BTK inhibitor, Jaypirca (pirtobrutinib). Results from two pivotal Phase 3 trials demonstrate that Jaypirca not only outperforms standard chemoimmunotherapy in first-line treatment but also meets non-inferiority benchmarks against the established drug ibrutinib. These findings could pave the way for Jaypirca to become a new standard of care for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) across multiple treatment settings.

Clinical Trials Autoimmune Diseases Healthcare & Pharmaceuticals News

New 48-Week Data Shows TREMFYA® (guselkumab) Substantially Inhibits Joint Damage in Psoriatic Arthritis

JohnsonAndJohnson

New long-term data from the Phase 3b APEX study confirms that TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to substantially inhibit the progression of structural joint damage in patients with active psoriatic arthritis, with results sustained through 48 weeks.

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Roche’s Fenebrutinib Shows “Unprecedented” Phase III Success in Both Relapsing and Progressive Multiple Sclerosis

Roche

Roche announced today that its investigational oral medication, fenebrutinib, has met primary endpoints in two separate, pivotal Phase III studies for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The drug significantly reduced relapse rates in RMS and slowed disability progression in PPMS, positioning it as a potential first-in-class, high-efficacy oral treatment for the two most common forms of the disease.

Clinical Trials Healthcare & Pharmaceuticals News

Merck’s Oral PCSK9 Inhibitor, Enlicitide, Shows Significant LDL-C Reduction in Phase 3 CORALreef HeFH Trial

Merck MSD

Merck announced promising results from its pivotal Phase 3 CORALreef HeFH trial. The study found that enlicitide, an investigational, once-daily oral PCSK9 inhibitor, significantly reduced low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH). These late-breaking data were presented at the AHA Scientific Sessions 2025.

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Gilead’s Trodelvy Misses Primary Goal in First-Line Breast Cancer Study, But Hope Remains for Overall Survival

Gilead

Gilead Sciences announced its Phase 3 ASCENT-07 trial for Trodelvy® in first-line HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of progression-free survival (PFS). However, the company reported an “early trend” favoring Trodelvy for the key secondary endpoint of overall survival (OS), and the study will continue to gather more data on this measure.

Clinical Trials Healthcare & Pharmaceuticals News

Eli Lilly’s Eloralintide Shows Up to 20.1% Weight Loss in Phase 2 Obesity Study

Eli Lilly and Company

Eli Lilly and Company announced positive Phase 2 trial results for eloralintide, its investigational once-weekly, selective amylin receptor agonist. The study met its primary endpoint, showing that adults with obesity or overweight achieved mean weight reductions of up to 20.1% over 48 weeks, compared to 0.4% with placebo. The drug also demonstrated a favorable tolerability profile, with mild-to-moderate gastrointestinal symptoms being the most common adverse events. Lilly plans to advance eloralintide to Phase 3 trials by the end of 2025.

Clinical Trials News Oncology

Lilly’s Verzenio® Shows Significant Survival Benefit in High-Risk Early Breast Cancer

Eli Lilly and Company

Eli Lilly and Company announced major findings from the seven-year monarchE trial. Their CDK4/6 inhibitor, Verzenio® (abemaciclib), is the first in its class to demonstrate a statistically significant overall survival benefit for patients with HR+, HER2-, high-risk early breast cancer when added to endocrine therapy.

Clinical Trials Autoimmune Diseases Healthcare & Pharmaceuticals News

Roche Highlights New OCREVUS® Data Demonstrating Benefit in Diverse MS Populations and Presents Promising Long-Term Fenebrutinib Results at ECTRIMS 2025

Roche

Roche is set to present a wealth of new data at the 41st ECTRIMS Congress, highlighting the expanding benefits of its flagship multiple sclerosis therapy, OCREVUS® (ocrelizumab). New findings demonstrate a significant reduction in disability progression for adults with advanced primary progressive MS (PPMS) and reinforce its safety for pregnant women and their infants. The presentation will also include the first comparative data for OCREVUS in pediatric MS. Alongside these updates, Roche will showcase promising two-year results for its investigational oral BTK inhibitor, fenebrutinib, which showed near-complete suppression of disease activity in patients with relapsing MS ahead of pivotal Phase III readouts.