Skip to content
Bending the Curve Trial by Trial
?

eNRGy

Zenocutuzumab in advanced NRG1 fusion-positive cancer (eNRGy)

Phase 2N = 204NCT02912949

Population
Advanced NRG1 fusion-positive cancer, 12 tumour types (pancreatic cancer and non-small-cell lung cancer the largest subsets reported)
Design
Registrational, single-group phase 2 study: zenocutuzumab 750 mg intravenously every 2 weeks in advanced NRG1 fusion-positive cancer of any tumour type. Primary end point overall response by investigator assessment. Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Zenocutuzumab (experimental, n = 204): Zenocutuzumab 750 mg intravenously every 2 weeks
People
Schram AM
Show the numbers
Results reported for eNRGy
EndpointAnalysisZenocutuzumabControlEffect
ORRPancreatic cancer patients with measurable disease enrolled at least 24 weeks before the data cut-off (36)Overall response (complete or partial) by investigator assessmentprimarySchram 202542% (25–59%)—15 of 36 patients.
ORRAll tumour types: patients with measurable disease enrolled at least 24 weeks before the data cut-off (158)primarySchram 202530% (23–37%)——
DORAll tumour types, responders among the 158 patientsprimarySchram 2025median 11.1 months (7.4–12.9)—19% of responses were ongoing at the data cut-off.
PFSAll tumour types (204 treated)primarySchram 2025median 6.8 months (5.5–9.1)——
DORPancreatic adenocarcinoma responders in the primary efficacy set (15 of 36 patients)Duration of response among respondersprimarySchram 2025median 7.4 months (4.0–11.2)——
PFSPancreatic adenocarcinoma subset (Table S7 of the full text)primarySchram 2025median 9.2 months (5.5–11.2)——
Results reported for eNRGy
EndpointAnalysisZenocutuzumabControlEffect
ORRPancreatic cancer patients with measurable disease enrolled at least 24 weeks before the data cut-off (36)Overall response (complete or partial) by investigator assessmentprimarySchram 202542% (25–59%)—15 of 36 patients.
ORRAll tumour types: patients with measurable disease enrolled at least 24 weeks before the data cut-off (158)primarySchram 202530% (23–37%)——
DORAll tumour types, responders among the 158 patientsprimarySchram 2025median 11.1 months (7.4–12.9)—19% of responses were ongoing at the data cut-off.
PFSAll tumour types (204 treated)primarySchram 2025median 6.8 months (5.5–9.1)——
DORPancreatic adenocarcinoma responders in the primary efficacy set (15 of 36 patients)Duration of response among respondersprimarySchram 2025median 7.4 months (4.0–11.2)——
PFSPancreatic adenocarcinoma subset (Table S7 of the full text)primarySchram 2025median 9.2 months (5.5–11.2)——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Zenocutuzumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsZenocutuzumab
0100.0%
764.6%
1441.7%
2126.9%
2817.4%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Zenocutuzumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsZenocutuzumab
0100.0%
466.5%
940.0%
1326.6%
1717.7%
Primary publication: 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. PubMedDOI

Appears in

Sources

  1. 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.

    PubMedDOI