MorphoSys AG received the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tulmimetostat, for the treatment of patients with advanced, recurrent or metastatic endometrial cancer. Tulmimetostat is MorphoSys’ third clinical program to receive Fast Track designation from the FDA after Pelabresib in 2018 and tafasitamab in 2014.
Tulmimetostat, the company’s investigational next-generation dual inhibitor of EZH2 and EZH1, was designed to improve on first generation EZH2 inhibitors through increased potency, longer residence time on target and a longer half-life, offering the potential for enhanced anti-tumor activity. It is intended for the treatment of patients with advanced, recurrent or metastatic endometrial cancer harboring AT-rich interacting domain containing protein 1A (ARID1A) mutations and who have progressed on at least one prior line of treatment.
The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines intended to treat serious conditions and potentially address an unmet medical need, with the goal of getting these important, new therapies to patients earlier. The Fast Track designation in endometrial cancer was granted based on preclinical results and preliminary clinical data from an ongoing Phase 1/2 study. This study is investigating tulmimetostat as a monotherapy in patients with advanced solid tumors or lymphomas, including ARID1A-mutated endometrial carcinoma and ovarian clear cell carcinoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma and castration-resistant prostate cancer.
According to Dr. Tim Demuth, Chief Research and Development Officer von MorphoSys, the Fast Track designation from the FDA for tulmimetostat in ARID1A-mutated endometrial cancer underscores the investigational therapy’s potential in a patient population with limited treatment options.
Tulmimetostat is MorphoSys’ third clinical program to receive Fast Track designation from the FDA. Pelabresib, an investigational BET inhibitor, received Fast Track designation for myelofibrosis in 2018, and tafasitamab, a CD19-targeting immunotherapy, received this designation for relapsed or refractory diffuse large B-cell lymphoma in 2014.
Updated results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June.