eNRGy
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy): NRG1 fusion-positive cholangiocarcinoma efficacy population
Phase 2N = 19NCT02912949
- Population
- Adults with advanced, unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma (19 patients evaluated for efficacy; 100% intrahepatic among the 16 with reported information; 17 had prior systemic therapy).
- Design
- Multicentre, open-label, multi-cohort study (eNRGy) of zenocutuzumab 750 mg intravenously every 2 weeks until unacceptable toxicity or disease progression; this record covers the NRG1 fusion-positive cholangiocarcinoma efficacy population described in the FDA label. NRG1 fusions were determined prospectively in local laboratories by next-generation sequencing. Major efficacy outcome measures: confirmed ORR and duration of response by blinded independent central review (RECIST v1.1). Single-arm; no comparison group.
- Arms
- Zenocutuzumab (experimental, n = 19): Zenocutuzumab 750 mg intravenously every 2 weeks
- People
- Schram AM
Show the numbers
| Endpoint | Analysis | Zenocutuzumab | Control | Effect |
|---|---|---|---|---|
| ORRNRG1 fusion-positive cholangiocarcinoma, efficacy evaluation set in the FDA label (19)Confirmed overall response rate assessed by blinded independent central review (RECIST v1.1) | primarySource 2026 | 36.8% (16.3–61.6%) | — | Complete response 5.3% and partial response 31.6%. Duration of response ranged from 2.8 to 12.9 months (a range, not a median), and 28.6% of patients had an observed duration of response of at least 6 months, as printed in the label. |
| Endpoint | Analysis | Zenocutuzumab | Control | Effect |
|---|---|---|---|---|
| ORRNRG1 fusion-positive cholangiocarcinoma, efficacy evaluation set in the FDA label (19)Confirmed overall response rate assessed by blinded independent central review (RECIST v1.1) | primarySource 2026 | 36.8% (16.3–61.6%) | — | Complete response 5.3% and partial response 31.6%. Duration of response ranged from 2.8 to 12.9 months (a range, not a median), and 28.6% of patients had an observed duration of response of at least 6 months, as printed in the label. |
Appears in
Sources
Schram AM, Goto K, Kim DW, Macarulla T, Hollebecque A, O'Reilly EM, et al. Efficacy of Zenocutuzumab in NRG1 Fusion-Positive Cancer. N Engl J Med. 2025;392(6):566-576.
FDA. Prescribing information, Bizengri (zenocutuzumab-zbco), label version effective 19 May 2026 (openFDA drug label record, set ID 203daea4-fc87-40a4-a92f-ba2351b16de1); Indications and Usage and Clinical Studies sections.