BALSTILIMAB

AGEN2034 (anti-PD-1)

PD-1 (programmed cell death protein 1) is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. In 2018, the Nobel Prize in Medicine was awarded for the establishment of PD-1 as a cancer immunotherapy target. Agenus has applied these scientific principles to create a therapy designed to treat cancer, AGEN2034.

AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2.

AGEN2034 is clinically active in patients with advanced or refractory cancer.

In August 2021, Agenus announced the publication of results from a global Phase 2 clinical study of balstilimab monotherapy in recurrent/metastatic cervical cancer in the international peer reviewed journal Gynecologic Oncology. In the 140 evaluable patients, overall response rate (ORR) was 15%, disease control rate (DCR) was ~50% and the median duration of response was 15.4 months. In the 85 evaluable patients with PD-L1 positive tumors, an ORR of 20% was achieved.

Agenus controls worldwide rights to AGEN2034, except for certain South American rights, which are controlled by Recepta Biopharma, and Greater China rights, which are exclusively licensed to Betta Pharmaceuticals.

Latest Clinical Trials

Metastatic Cervical Cancer

NCT04943627 (BRAVA)

Phase 3, open-label, randomized study with single-agent Balstilimab (BAL) or Investigator Choice (IC) chemotherapy (single-agent gemcitabine, irinotecan, pemetrexed, vinorelbine, or topotecan) in patients with recurrent, persistent, or metastatic cervical cancer who have progressed after receiving platinum based chemotherapy

Second-line cervical cancer

NCT03894215 (RaPiDS)

Randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 – monotherapy) or with AGEN1884 (Treatment Arm 2 – combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy

Second-line cervical cancer

NCT03104699

Phase 2 expansion to evaluate efficacy in subjects with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a platinum-based treatment regimen

Latest Publications and Abstracts

European Society for Medical Oncology (ESMO) Virtual

September 16-21, 2021

Balstilimab (anti-PD-1) in Combination with Zalifrelimab (anti-CTLA-4): Final Results from a Phase 2 Study in Patients (pts) with Recurrent/metastatic (R/M) Cervical Cancer (CC). O'Malley, et al.

European Society for Medical Oncology (ESMO) Virtual

September 16-21, 2021

Balstilimab Alone or in Combination with Zalifrelimab as Second-line Treatment for Patients with Previously Treated Recurrent/metastatic Cervical Cancer: a Randomized, Placebo-Controlled Phase II Trial (RaPiDS/GOG-3028). Randall, et al.

Gynecologic Oncology

August 25, 2021

Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab in patients with recurrent and/or metastatic cervical cancer. O'Malley, et al.

American Society of Clinical Oncology (ASCO)

June 3-7, 2021

Differentiated Activity Profile for the PD-1 Inhibitor Balstilimab. C.Joyce, et al.

SGO 2021 Virtual Annual Meetings on Women's Cancer Abstracts

March 19-22, 2021

RaPiDS (GOG-3028): A Randomized Phase II Study of Balstilimab (AGEN2034) as Monotherapy or in Combination with Zalifrelimab (AGEN1884) in Second-Line Cervical Cancer. O'Malley, et al.

Oncogene

January 26, 2021

Is PD-L1 a consistent biomarker for anti-PD-1 therapy? The model of balstilimab in a virally-driven tumor. Grossman, et al.

European Society for Medical Oncology (ESMO) Virtual

September 19-21, 2020

Balstilimab (anti-PD-1) Alone and in Combination with Zalifrelimab (anti-CTLA-4) for Recurrent/Metastatic (R/M) Cervical Cancer (CC) Preliminary Results of Two Independent Ph2 Trials . O'Malley, et al.

Society for Immunotherapy of Cancer (SITC)

November 6-10, 2019

Single-agent Activity of a Novel PD-1 Inhibitor, AGEN2034, in Recurrent Ovarian Cancer. O’Malley, et al.

European Society for Medical Oncology (ESMO)

October 19-23, 2018

Phase 1/2, Open-Label, Multiple Ascending Dose Trial of AGEN2034, an Anti–PD-1 Monoclonal Antibody, in Advanced Solid Malignancies: Results of Dose Escalation in Advanced Cancer and Expansion Cohorts in Subjects With Relapsed/Refractory Cervical Cancer. Drescher, et al.

European Society for Medical Oncology (ESMO)

October 19-23, 2018

Phase 1/2 Study of CTLA-4 Inhibitor AGEN1884 + PD-1 Inhibitor AGEN2034 in Patients With Advanced/Refractory Solid Tumors, With Expansion Into Second-Line Cervical Cancer and Solid Tumors. Coward et al.

American Society of Clinical Oncology (ASCO)

June 1-5, 2018

Phase One Open-Label, Ascending Dose Trial of AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Advanced Solid Malignancies: Results of Dose Escalation. Moore, et al.

American Association for Cancer Research (AACR)

April 14-18, 2018

Evaluation of Peripheral T Cell Subset Proliferation as a Pharmacodynamic Assay to Guide the Development of Anti-CTLA-4 and PD-1 Antibody Combinations in Patients With Solid Tumors. de Souza, et al.

Society for Immunotherapy of Cancer (SITC)

November 9-12, 2017

AGEN2034, a Novel anti-PD-1 Antibody that Combines Effectively With CTLA-4 Pathway Blockade to Enhance T Cell Activity. Chand, et al.