Agenus posts results for zalifrelimab plus balstilimab trial in advanced cervical cancer

Agenus posted long-awaited data from a completed combination immunotherapy trial in solid tumors, with a focus on cervical cancer.

• The trial tested zalifrelimab (AGEN1884) in combination with balstilimab (AGEN2034) in participants with locally advanced, recurrent and/or metastatic solid tumors including cervical cancer¹. The study is listed as completed, with a start date of December 18, 2017 and both primary and study completion on July 15, 2022¹.
• Results were first posted on August 11, 2026, the same date as the last update to the record. Enrollment reached 175 participants¹ across the Phase 1 dose-escalation and Phase 2 expansion portions.
• After dose escalation, the safety monitoring committee selected CDL2, zalifrelimab 1 mg/kg every 6 weeks plus balstilimab 3 mg/kg every 2 weeks, as the recommended phase 2 dose¹.
• The Phase 2 portion enrolled an advanced cervical cancer cohort, treated at the recommended phase 2 dose for up to 2 years or until progression or unacceptable toxicity¹. The primary outcome for this phase was objective response rate as assessed by an independent endpoint review committee, defined as the percentage of participants with a confirmed best overall response of partial or complete response under RECIST 1.1¹.
• In the dose-escalation phase, the primary outcome tracked the number of participants experiencing dose-limiting toxicities during the first 21 days of treatment, with any DLT leading to permanent withdrawal of both drugs¹. Agenus Inc. is listed as the lead sponsor of the trial.