Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AGEN1884
Zalifrelimab · 4 trials · 7 indications
Objective Response Rate (ORR): Complete Response (CR) + Partial Response (PR) according to RECIST 1.1 criteria
The ORR was defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) or complete response (CR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
The number of participants with an occurrence of a DLT during dose escalation during the first 21 days of treatment in Phase 1 are reported. Any DLT immediately led to permanent withdrawal of zalifrelimab and balstilimab.
A DLT was defined as a Grade ≥3 adverse drug reaction (ADR), according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, occurring in the DLT evaluation period (28 days after the initial administration of zalifrelimab). An ADR was defined as all noxious and unintended responses to a medicinal product, related to any dose.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. A treatment-related AE was one in which a causal relationship between the medicinal product and the AE was at least a reasonable possibility and could not be ruled out. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Blood samples were collected at designated timepoints to characterize Cmax of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as micrograms/milliliter (ug/mL).
Blood samples were collected at designated timepoints to characterize AUC0-21d of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as hour times ug/mL (hour\*ug/mL).
| Arm | Type | Description |
|---|---|---|
| Castration-resistant prostate cancer | EXPERIMENTAL | Evofosfamide + zalifrelimab + balstilimab |
| Pancreatic cancer | EXPERIMENTAL | Evofosfamide + zalifrelimab + balstilimab |
| Human papilloma virus-negative squamous cell carcinoma of the head and neck | EXPERIMENTAL | Evofosfamide + zalifrelimab + balstilimab |
| Investigational treatment | EXPERIMENTAL | Conventional Chemotherapy (Gemcitabine + nab-paclitaxel) plus NLM-001 plus Zalifrelimab |
| Phase 1 - Dose 1: Zalifrelimab + Balstilimab | EXPERIMENTAL | Participants received zalifrelimab (1 mg/kg every 6 weeks \[Q6W\]) in combination with balstilimab (1 mg/kg every 2 weeks \[Q2W\]). |
| Phase 1 - Dose 2: Zalifrelimab + Balstilimab | EXPERIMENTAL | Participants received zalifrelimab (1 mg/kg Q6W) in combination with balstilimab (3 mg/kg Q2W). |
| Phase 2: Zalifrelimab + Balstilimab | EXPERIMENTAL | Participants received the RP2D of zalifrelimab (1 mg/kg Q6W) in combination with balstilimab (3 mg/kg Q2W). |
| Zalifrelimab | EXPERIMENTAL | Participants received zalifrelimab intravenously. |
| Name | Type | Description |
|---|---|---|
| Evofosfamide | DRUG | Evofosfamide administered on Days 1 and 8 of Cycles 1, 2, and 3. |
| Zalifrelimab | DRUG | Zalifrelimab administered on Day 8 of Cycles 1, 3, and 5. |
| Balstilimab | DRUG | Balstilimab administered every 2 weeks beginning on Day 8 of Cycle 1. |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy). |
| Nab paclitaxel | DRUG | Nab-Paclitaxel 125 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy). |
| NLM-001 | DRUG | NLM-001 will be administered three cycles consecutively followed by two rest cycles. |
Inclusion Criteria: 1. Histologically confirmed locally advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, or HPV-negative SCCHN for which no other lines of standard therapy with demonstrated clinical benefit are available or appropriate as treatment. 2. Appropriate to ...
Zalifrelimab is an investigational monoclonal antibody being studied in advanced solid cancers, including cervical cancer, metastatic prostate cancer, and pancreatic ductal adenocarcinoma. It is also being tested in metastatic head and neck squamous cell carcinoma. It is not approved for any indication and remains in clinical development.
Zalifrelimab targets CTLA4, also known as CTLA-4, and acts as an inhibitor of that target. By binding CTLA4, a checkpoint receptor on T cells, the antibody is designed to interfere with a brake on immune activation. This is the mechanism under study in the oncology trials listed for the drug.
Zalifrelimab is being developed by Agenus Inc., which trades on the Nasdaq under the ticker AGEN. Agenus is the sponsor behind the clinical program evaluating the antibody across several solid tumor settings, including combinations with other agents such as balstilimab.
Zalifrelimab is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 program includes studies in advanced solid tumors, cervical cancer, pancreatic ductal adenocarcinoma, and metastatic prostate cancer.
Zalifrelimab has been studied in NCT03495882 in metastatic or locally advanced solid tumors with a cervical expansion, NCT02694822 in advanced or refractory cancers, and NCT04827953 in pancreatic ductal adenocarcinoma. NCT06782555 is currently recruiting patients with metastatic prostate cancer, head and neck squamous cell carcinoma, and pancreatic cancer.
Yes. Zalifrelimab is also known as AGEN1884, which is the designation used in the earlier Phase 1 study NCT02694822. The two names refer to the same anti-CTLA-4 human monoclonal antibody developed by Agenus Inc.