FDA Grants Fast Tract Designation to VT3989 for Mesothelioma

The U.S. Food and Drug Administration (FDA) has granted fast track designation to VT3989, a novel investigational small molecule cancer therapeutic, for the treatment of patients with unresectable malignant nonpleural or pleural mesothelioma whose disease has progressed on prior immune checkpoint inhibitor therapy and platinum-based chemotherapy.

The development was announced in a news release issued by Vivace Therapeutics, Inc., a small molecule discovery and development company that is behind VT3989.

Fast Track Designation for VT3989 in Refractory Metastatic Solid Tumors

Fast track, as the FDA explains on its website, is a process that is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need in order to get important new drugs to patients earlier.

"We are pleased to receive fast track designation from the FDA for VT3989 in this patient population, which is in desperate need of new and effective therapeutic options. This designation represents another important step in our ongoing development of VT3989 and will offer key advantages as we continue on our path toward potential commercialization of this first-in-class and best-in-class therapy," Sofie Qiao, president and chief executive officer of Vivace Therapeutics, stated in the news release.

VT3989, as explained in the news release, is a a transcriptional enhanced associate domain autopalmitoylation inhibitor that is designed to target the Hippo pathway, and has been evaluated in more than 200 patients so far in an ongoing, open-label phase 1 clinical study.

The clinical study, according to its listing on clinicaltrials.gov, is currently recruiting patients at a dozen locations in the United States and Australia. With an anticipated eventual enrollment of 336 patients, the study has an estimated primary completion date of Dec. 24, 2026 and a study completion date of June 2, 2027.

The trial is designed to evaluate the safety, tolerability, pharmacokinetics and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural and non-pleural malignant mesothelioma.

What Is Mesothelioma

Mesothelioma, as explained by the American Cancer Society on its website, is cancer that starts in cells in the linings of certain parts of the body, most commonly the linings of the chest or abdomen.

Pleural mesotheliomas, which start in the chest, make up more than 75% of mesotheliomas. Most of the remaining cases are peritoneal mesotheliomas, which start in the abdomen, although in very rare cases they can start in the covering around the heart (pericardial mesotheliomas) or in the covering layer of the testicles (mesotheliomas of the tunica vaginalis). Additionally, mesotheliomas are grouped into three main types based on how the cancer cells look, with more than half being epithelioid, which tends to have a better outlook, versus sarcomatoid (fibrous) or mixed (biphasic).

There are, according to the American Cancer Society, approximately 3,000 new cases of mesothelioma diagnosed in the United States each year. The rate of cases increased from the 1970s through the early 1990s, but has since leveled off and slightly decreased.

Women experience a lower rate of mesothelioma, and it has been fairly steady for some time. Mesothelioma, the organization noted, is more common in White, Hispanic and Latino people than in African Americans or Asian Americans, and they are more common in older people than in younger people, with, for example, the average age of a person being diagnosed with pleural mesothelioma being 72.

References

1. “Vivace Therapeutics' VT3989 Granted Fast Track Designation by the U.S. Food and Drug Administration for the Treatment of Mesothelioma,” news release; https://www.prnewswire.com/news-releases/vivace-therapeutics-vt3989-granted-fast-track-designation-by-the-us-food-and-drug-administration-for-the-treatment-of-mesothelioma-302577269.html
2. “Fast Track,” FDA; https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
3. “Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors,” https://clinicaltrials.gov/study/NCT04665206#study-overview
4. “Mesothelioma,” American Cancer Society; https://www.cancer.org/cancer/types/malignant-mesothelioma.htm

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