BioNTech (BNTX) said Saturday that its drug, trastuzumab pamirtecan, met its primary goal in a phase 2 study for treating recurrent endometrial cancer.

In a study of 73 patients previously treated with checkpoint inhibitors, BioNTech reported an objective response rate of 49.3%, achieving the trial's primary efficacy endpoint. In a study of 96 centrally tested patients, BioNTech reported an objective response rate of 47.9%, meeting the goals set for the broader group.

The data showed clinically meaningful efficacy and a manageable safety profile for trastuzumab pamirtecan monotherapy across all HER2 immunohistochemistry expression levels, the company said.

BioNTech, which is developing the drug along with DualityBio, said they plan to file a biologics license application this year, subject to regulatory feedback from the US Food and Drug Administration.