The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for balstilimab for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 designed to block programmed cell death protein (PD-1) from interacting with the PD-L1 and PD-L2 ligands. The BLA submission is based on data from a randomized, noncomparative, pivotal phase 2 trial (ClinicalTrials.gov Identifier: NCT03894215) that assessed the efficacy and safety of balstilimab in patients 18 years of age and older with advanced cervical cancer who had relapsed or progressed after receiving first-line platinum-based chemotherapy.

Patients were randomly assigned to receive either balstilimab monotherapy or balstilimab in combination with the Company’s investigational anti-CTLA-4, zalifrelimab. The primary endpoint was the overall response rate (ORR), as assessed by RECIST v1.1.

Findings demonstrated an ORR of 15% in all tumors and a response rate of 20% in PD-L1 positive tumors; the median duration of response was 15.4 months. Balstilimab was also found to be responsive across histology subgroups and in certain patients typically unresponsive to commercially available therapies.


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A Prescription Drug User Fee Act (PDUFA) target date of December 16, 2021 has been set for the application.

References

  1. Agenus announces U.S. FDA acceptance and Priority Review of balstilimab Biologics License Application for the treatment of recurrent or metastatic cervical cancer. [press release]. Lexington, MA: Agenus Inc.; June 17, 2021. 
  2. Agenus’ presentations at ASCO 2021 demonstrate differentiated activity of balstilimab and provide clinical update on AGEN2373. [press release]. Lexington, MA: Agenus Inc.; June 4, 2021. 
  3. Agenus submits balstilimab Biologics License Application to the U.S. FDA for patients with recurrent or metastatic cervical cancer. [press release]. Lexington, MA: Agenus Inc.; April 19, 2021.