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Zenocutuzumab-zbco (BIZENGRI®) Shows Durable Efficacy in Patients with Treatment-Naïve NRG1+NSCLC: Updated eNRGy Trial Results Presented at IASLC-ASCO NACLC
Phase 2 eNRGy trial shows 35% overall response rate and 65% clinical benefit rate in treatment-naïve NRG1+ NSCLC patients, with a median response duration of 17.1 months.
- Partner Therapeutics released updated post hoc analysis of the Phase 2 eNRGy trial at NACLC, showing durable responses to zenocutuzumab‑zbco in NRG1+ NSCLC.
- Because the indications were approved under accelerated approval, zenocutuzumab‑zbco received FDA approval based on ORR and DOR, with continued approval contingent on confirmatory trial and tissue‑based RNA NGS essential for detecting NRG1 gene fusions.
- The Phase 2 eNRGy analysis found ORR of 35% in 20 treatment‑naïve and 31% in 121 previously treated patients, with all adverse events Grade 1–2.
- Danielle Hicks, Chief Patient Officer, GO2 for Lung Cancer, said the results mark meaningful progress for patients and families with NRG1+ NSCLC, reinforcing the need for biomarker‑driven lung cancer care.
- Because IRRs concentrate in the first infusion, BIZENGRI requires emergency resuscitation equipment and trained staff; infusion-related reactions occurred in 13% of patients with a BOXED WARNING for embryo-fetal toxicity and pulmonary and cardiac risks.
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Zenocutuzumab-zbco (BIZENGRI®) Shows Durable Efficacy in Patients with Treatment-Naïve NRG1+NSCLC: Updated eNRGy Trial Results Presented at IASLC-ASCO NACLC
LEXINGTON, Mass., Dec. 6, 2025 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company, announced new data from a post hoc analysis of the Phase 2 eNRGy trial (NCT02912949) evaluating zenocutuzumab in patients with treatment-naïve non-small cell lung…
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