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.

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.

Roche Announces Positive Phase III ALLEGORY Study Results for Gazyva®/Gazyvaro® in Systemic Lupus Erythematosus

Roche

Roche’s Phase III ALLEGORY study for Gazyva® (obinutuzumab) in systemic lupus erythematosus (SLE) met its primary and all key secondary endpoints. These “unprecedented” results demonstrate Gazyva’s potential to effectively control disease activity and may delay or prevent further organ damage in people with SLE.

TREMFYA® (guselkumab) Demonstrates Durable Two-Year Remission in Crohn’s Disease, New Phase 3 Data Show

JohnsonAndJohnson

New 96-week data from the Phase 3 GALAXI and GRAVITI studies show high rates of sustained remission for TREMFYA® (guselkumab) in Crohn’s disease. At two years, over 86% of patients on maintenance doses achieved clinical remission, reinforcing its long-term efficacy as the only fully subcutaneous IL-23 inhibitor for the condition.

Tebipenem HBr Shows Promise as First Oral Carbapenem for Complicated Urinary Tract Infections

GSK - GlaxoSmithKline

Positive data from GSK’s pivotal PIVOT-PO Phase III trial show that oral tebipenem HBr is a promising new treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The study, which was stopped early for efficacy, demonstrated that the oral antibiotic was non-inferior to the current standard of care, intravenous imipenem-cilastatin. These findings mark a significant step towards the first oral carbapenem for cUTIs, potentially changing the treatment landscape for patients and addressing the challenge of antimicrobial resistance.

Gilead’s Trodelvy Shows Significant Promise in Treating Aggressive Breast Cancer

Gilead

Results from the ASCENT-03 study reveal that Trodelvy (sacituzumab govitecan-hziy) significantly enhances outcomes for patients with metastatic triple-negative breast cancer. The drug lowered the risk of disease progression or death by 38% and provided a longer duration of response compared to chemotherapy. This positions Trodelvy as a potential new standard of care for this aggressive form of breast cancer, offering hope to a patient population with limited treatment options.

Breakthrough in Bladder Cancer Treatment: PADCEV and KEYTRUDA Combination Significantly Improves Survival

pfizer news

A landmark clinical trial reveals a powerful new weapon against aggressive bladder cancer. The combination of PADCEV™ and KEYTRUDA®, administered before and after surgery, has been shown to significantly improve survival rates for patients with muscle-invasive bladder cancer who are ineligible for cisplatin chemotherapy. These groundbreaking results could establish a new standard of care, offering profound hope for a patient population with previously limited options.

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.