FDA refused to approve EpCAM ADC therapy for bladder cancer!

Article source: Medical Rubik's Cube Info

On August 13, Sensen Bio announced that it has received a full response letter from the FDA regarding its innovative ADC drug Vicineum (oportuzumab monatox) for the treatment of high-risk non-muscular invasive bladder cancer (NMIBC) patients who do not respond to BCG vaccine (BCG)

Vicineum is an antibody-conjugated drug conjugated with a recombinant fusion protein oportuzumab that can target epithelial cell adhesion molecules (EpCAM) and Pseudomonas exotoxin A, which can be injected locally

In August 2019, Sesen Bio announced the primary and secondary endpoint data of the Phase III VISTA study (NCT02449239) of Vicinium in the treatment of BCG-non-responsive NMIBC patients

The VISTA study is a 24-month multi-center, single-arm, open-label study, enrolling 133 patients with high-grade NMIBC carcinoma in situ (CIS) or papillary carcinoma (with or without CIS) who have received BCG treatment includes 3 cohorts

As of May 29, 2019, the complete remission rates of cohort 1 in the 3rd, 6th, 9th and 12th months were 39%, 26%, 20%, and 17%, and cohort 2’s data were 57%, 57%, and 43.

A preclinical study conducted by Sesen Bio found that EpCAM is overexpressed on NMIBC cells, but only slightly expressed on normal bladder tissue cells, or not expressed at all

Sesen Bio has reached cooperation agreements with Hikma Pharmaceuticals and Qilu Pharmaceuticals respectively, granting Vicineum development rights in the Middle East and North Africa, and Greater China

Bladder cancer is one of the malignant tumors with a high incidence in the world.