#USA #San Mateo #Mesothelioma #Vivace Therapeutics #VT3989

Vivace Therapeutics' Game-Changing Therapy VT3989

Vivace Therapeutics, Inc., a pioneering company specializing in cancer drug development, has recently reported ground-breaking data from their Phase I/II clinical trial showcasing their innovative therapy, VT3989, designed to target the Hippo signaling pathway. This therapy has shown substantial promise in patients suffering from refractory mesothelioma, a particularly difficult-to-treat cancer prevalent among individuals with a history of asbestos exposure.

At the esteemed European Society for Medical Oncology (ESMO) Congress 2025, the latest findings were presented, accompanied by a detailed publication in Nature Medicine. The results highlighted a noteworthy 32% overall response rate among participants, with 86% demonstrating disease control. Notably, the median progression-free survival was reported at 40 weeks—a striking improvement compared to the typical 15 weeks associated with existing salvage chemotherapy treatment protocols.

Study Design and Results

Conducted across multiple centers, this open-label study enrolled 22 heavily pretreated mesothelioma patients, all of whom had previously undergone either immunotherapy or chemotherapy regimes. The study was aimed at evaluating both the safety and efficacy of VT3989 as a potential new treatment option.

According to the chief medical officer of Vivace, Dr. Neelesh Sharma, the reported safety profile is promising, with minimal serious adverse effects. The adverse events recorded were predominantly mild to moderate, and the therapy displayed a 3.5% discontinuation rate due to side effects, an encouraging statistic for those observing clinical tolerability.

The most frequently reported side effects included mild fatigue, transient proteinuria (an increase of protein in urine), and minimal swelling in limbs, with a mere 8.7% of participants experiencing Grade 3 or 4 treatment-related adverse events.

Importance of the Findings

Dr. Timothy A. Yap, who is the lead clinical investigator from the University of Texas MD Anderson Cancer Center, expressed optimism regarding VT3989's significant therapeutic potential. He noted that the results reflect clinically meaningful disease control, especially in a cohort of patients who had few options left for treatment. "These findings exemplify the potential impact of a first-in-class therapy targeting an entirely new mechanism in the fight against mesothelioma," he remarked.

The drug is now set for transition into a Phase 3 registrational clinical trial, aiming for commencement in the first half of 2026. This progress marks a significant milestone in developing effective treatments for a type of cancer with few options available.

Future Directions and Regulatory Status

Adding to the excitement surrounding VT3989, the therapy has received Orphan Drug Designation as well as Fast Track Designation by the U.S. Food and Drug Administration (FDA), aimed at accelerating its availability for patients battling mesothelioma. This classification particularly highlights the importance of VT3989 for patients whose diseases have failed to respond to both platinum-based chemotherapy and immune checkpoint inhibitors.

With a total of $105 million raised thus far, Vivace Therapeutics is committed to advancing the clinical development of this innovative therapy. The promise shown by VT3989 not only provides hope to patients afflicted by refractory mesothelioma but also represents a significant step forward in cancer treatment strategies.

Vivace Therapeutics aims to continue pushing the boundaries of medical science with its first-in-class approach, focusing on addressing high unmet medical needs across various types of carcinomas. Interested parties can access the detailed ESMO presentation on their official website following the conference.