Aeterna Zentaris granted SPA for phase III endometrial cancer trial
The FDA has granted Aeterna Zentaris Special Protocol Assessment (SPA) for an upcoming phase III registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108.
"We are pleased with the agreement with the FDA which provides us with a clearly defined development and regulatory pathway for AEZS-108 in endometrial cancer," said Juergen Engel, PhD, president and CEO of Aeterna Zentaris. "AEZS-108's innovative targeted approach could offer a new treatment option for women with endometrial cancer and provide the company with a significant market opportunity."
The trial will be an open-label, randomized, multi-center phase III study conducted in North America and Europe, comparing AEZS-108 with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. The trial will enroll approximately 500 patients and the primary efficacy endpoint is improvement in median overall survival.