Tag: Clinical Data

Clinical Trials Healthcare & Pharmaceuticals News

AbbVie and Genmab Announce Positive Phase 3 Results for Epcoritamab in Relapsed/Refractory DLBCL

AbbVie

AbbVie and Genmab have announced significant topline results from the pivotal Phase 3 EPCORE® DLBCL-1 trial. The study marks a clinical milestone as the first Phase 3 trial to demonstrate a statistically significant improvement in progression-free survival (PFS) for a CD3xCD20 bispecific antibody monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Johnson & Johnson Announces Landmark Phase 3 Results: TECVAYLI® Reduces Risk of Disease Progression or Death by 71% in Early Relapse Multiple Myeloma

JohnsonAndJohnson

Johnson & Johnson (NYSE: JNJ) today announced groundbreaking topline results from the Phase 3 MajesTEC-9 study, demonstrating that TECVAYLI® (teclistamab-cqyv) monotherapy significantly improves outcomes for [Read More…]

Clinical Trials Healthcare & Pharmaceuticals News

Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial

Gilead

Gilead has announced positive Phase 3 results for its investigational single-tablet regimen (STR) of bictegravir and lenacapavir (BIC/LEN) in the ARTISTRY-2 trial. The new combination met its primary endpoint, demonstrating non-inferiority to BIKTARVY in maintaining viral suppression in adults with HIV-1. This novel two-drug regimen combines the potent integrase inhibitor bictegravir with the first-in-class capsid inhibitor lenacapavir, representing a potential new, simplified treatment option for long-term HIV management.

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.