Balstilimab

Unassigned

New Medicines

Recurrent/metastatic cervical cancer

Information

New molecular entity
Agenus
Agenus

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Pre-registration (Filed)
Sep 20 · Rolling BLA submission initiated with FDA [3].
Sep 20 · Two large clinical trials reported (phase not clarified in report) [1].

Category

Immune modulating antibody
There are around 3,200 new cervical cancer cases in the UK every year, 14th most common cancer in the UK [2].
Recurrent/metastatic cervical cancer
Intravenous

Trial or other data

Sep 20 · Results of two trials reported, in patients with recurrent/metastatic cervical cancer. The first (n=160) found balstilimab (PD-1) monotherapy trial achieves response rates of 14% in all treated patients and 19% in PD-L1 positive patients, the other (n=155) found balstilimab (PD-1) + zalifrelimab (CTLA-4) combination trial achieved response rates of 22% in all patients and 27% in PD-L1 positive patients [1].