Agenus Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The BLA has been submitted for the accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and includes data from its pivotal Phase 2 single-arm clinical trial, presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. These clinical data, along with preclinical data, suggest that balstilimab demonstrates differentiated features from other anti-PD-1 antibodies. The balstilimab BLA submission is based on an update to data presented at the ESMO Virtual Congress 2020 and published in an Oncogene editorial, which demonstrate that balstilimab shows potential differentiation from other anti-PD-1 antibodies. This updated dataset includes maturation of late patient responses, with the overall data showing response rates of 20% in PD-L1 positive tumors, 15% in all tumors (PD-L1 positive and negative), and a median duration of response of 15.4 months. In April 2020, the FDA granted Fast Track designation for balstilimab in recurrent or metastatic cervical cancer based on its potential to provide benefit to patients with a serious condition and unmet medical need. A global, randomized, Phase 3 confirmatory clinical trial designed to support global registration is planned.