Genmab's Rina-S shows sustained response in advanced endometrial cancer study

Genmab A/S said Saturday that updated data from a mid-stage trial showed its experimental drug, rinatabart sesutecan, demonstrated sustained anti-tumor activity in patients with advanced endometrial cancer.

The results, presented at a European medical conference, showed a 50% confirmed objective response rate in heavily pretreated patients, including two complete responses, according to the company.

After a median follow-up of one year in the Phase 1/2 study, nearly 64% of patients who responded to the treatment remained on it.

The U.S. Food and Drug Administration recently granted the therapy Breakthrough Therapy Designation for this use, and a late-stage Phase 3 trial is now underway.

“Women with advanced endometrial cancer are often facing a difficult path, while doctors are confronted with not having enough treatment options,” said Noelle Cloven, a study investigator.

“That’s why these data signals with Rina-S in the updated Phase 1/2 RAINFOL-01 data are encouraging – they point to the possibility of providing more choices for patients in the future.”

Rinatabart sesutecan is an antibody-drug conjugate, a type of therapy designed to deliver a cancer-killing agent directly to tumor cells.

Genmab said the most common side effects were related to blood cell counts and low-grade gastrointestinal issues, and that no signals of certain toxicities sometimes associated with the drug class, such as neuropathy or interstitial lung disease, were observed.