'We're excited to present this data from the largest study conducted to date, assessing the benefit from combined PD-1 and CTLA-4 inhibition in this patient population,' said
The trial showed that in the 125 evaluable patients treated with Bal/Zal, ORR was 25.6%; among PD-L1+ patients, the ORR was 32.8%. The Phase 2 trial was conducted in patients with recurrent/metastatic cervical cancer who had relapsed after prior platinum-based therapy, a population disproportionately represented by younger women, who have limited effective treatment options. Complete and partial responses were achieved by 8.0% and 17.6% of all patients respectively. The disease control rate in the trial was 52.0%. Responses achieved in patients were highly durable, with a median duration of response not yet reached (NR) following 21-month median follow-up (95% CI: 9.7 months to NR). Median overall survival was 12.8 months, with 69.2% and 53.3% of patients remaining alive at 6 and 12 months, respectively. Responses were observed across tumor histologies in the trial.
'With durable responses and a well-tolerated safety profile, the combined inhibition of PD-1 and CTLA-4 is a much-needed option for patients in this setting,' said
The Bal/Zal combination continued to show no unexpected toxicities and no new safety signals were identified. TRAEs leading to discontinuations occurred in 7.7% of patients.
About Cervical Cancer
Cervical cancer is a malignancy that originates in the cervix, the lower part of the uterus. It is the fourth most common cancer diagnosed among women globally, with nearly 14,500 patients expected to be diagnosed in the
About Balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market.
About Zalifrelimab
Zalifrelimab is a novel, fully human monoclonal immunoglobulin G1 (IgG1) designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) from interacting with its ligands CD80 and CD86. CTLA-4 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market.
About
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to the use of therapeutic candidates balstilimab and zalifrelimab, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability, and safety profile of balstilimab and zalifrelimab, both alone and in combination with other agents, including AGEN1181; future clinical development plans for balstilimab, zalifrelimab, and AGEN1181, alone or in combination; and our ability to obtain regulatory approval for balstilimab, zalifrelimab, and AGEN1181, alone or in combination. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the
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