FDA Grants Fast Track Designation to Zentalis’ Treatment of Uterine Serous Carcinoma

The U.S. Food and Drug Administration granted Fast Track designation to Zentalis’ ZN-c3, an oral WEE1 inhibitor product candidate, for the treatment of recurrent or persistent uterine serous carcinoma in adult women.

Photo: Anthony Sun, chairman and CEO of Zentalis

Uterine serous carcinoma (USC) is an aggressive variant of endometrial cancer that accounts for less than 10 percent of all endometrial cancers, but 80 percent of endometrial cancer–related deaths. In the United States, about 6,500 women are diagnosed annually, with about 70 percent presenting with Stage III or IV disease at diagnosis. Currently, the standard of care for treating USC is staging surgery together with chemotherapy or radiotherapy, but the recurrence rates post-surgery are extremely high and result in low patient survival rates. There remains an urgent medical need for transformative therapies that target the USC pathway.

ZN-c3 is a potentially first-in-class and best-in-class oral inhibitor of WEE1 in development for the treatment of advanced solid tumors. The inhibition of WEE1, a DNA damage response protein, aims to generate sufficient DNA damage in cancer cells, causing cell death, thereby preventing tumor growth and potentially causing tumor regression. ZN-c3 has broad potential as a monotherapy and in combination. Zentalis is currently evaluating this candidate in several ongoing and planned studies, including two potentially registrational monotherapy trials in USC and a biomarker-driven setting, as well as combination studies, including in combination with chemotherapy in patients with advanced ovarian cancer. ZN-c3 has received Orphan Drug and Rare Pediatric Disease designations from the FDA for pediatric osteosarcoma.

Fast Track designation aims to facilitate the development and accelerate the review of new therapeutics that are intended to treat serious or life-threatening conditions and that potentially address an unmet medical need. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.

“USC is a devastating endometrial cancer marked by low survival rates and high rates of recurrence. Receiving Fast Track designation for ZN-c3 is an important milestone, as it underscores the need for novel, effective treatment options for this aggressive and often fatal disease,” said Anthony Sun, chairman and CEO of Zentalis. “ZN-c3, our potentially first- and best-in-class oral WEE1 inhibitor, is a notable clinical advancement in DNA damage response and synthetic lethality and is currently being evaluated in a potentially registrational phase 2 trial in USC. We are grateful for the opportunity to have more frequent interactions with the FDA as we continue to quickly advance the development of this promising candidate for patients in need.”

Author: Rare Daily Staff