Partner Therapeutics Unveils Promising Findings of Zenocutuzumab for Cholangiocarcinoma Patients

Partner Therapeutics Announces Publication of Results from eNRGy Trial

On July 2, 2026, Partner Therapeutics, Inc. (PTx), a fully integrated biotechnology firm, made headlines by announcing the publication of results from the cholangiocarcinoma cohort of the eNRGy trial (NCT02912949) in the Journal of Clinical Oncology (JCO). The findings support the FDA's recent expedited approval of BIZENGRI® (zenocutuzumab-zbco) for treating adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion.
The approval comes particularly as a response to the pressing unmet medical needs faced by patients suffering from this rare cancer.
Significance of the eNRGy Trial
The eNRGy trial evaluates the effectiveness of zenocutuzumab specifically in patients with solid tumors that have NRG1 gene fusions. In the recent publication encompassing 22 patients with unresectable or metastatic cholangiocarcinoma, crucial data emerged. Out of these, 19 patients were evaluated for efficacy. Notably, a median of one prior line of therapy had been administered to these patients. The results showed a commendable overall response rate (ORR) of 36.8%, with a median duration of response lasting 7.4 months and median progression-free survival extending to 9.2 months. The clinical benefit rate, which accounts for patients achieving either a complete or partial response or stable disease lasting over six months, was recorded at 57.9%.
Importantly, the data revealed that the RNA-based next-generation sequencing (NGS) method successfully identified 100% of the NRG1 fusions, in stark contrast to only 29% detected by DNA-based testing. Such a significant difference underscores the necessity for more precise molecular testing in identifying the patient population who might benefit from this targeted therapy.

Zenocutuzumab's Favorable Tolerability Profile
Zenocutuzumab has shown a generally favorable tolerability profile. Treatment-related adverse events mainly fell under grade 1-2, with diarrhea, fatigue, and nausea being commonly reported but manageable. Remarkably, no patients had to discontinue treatment due to these adverse effects, highlighting the therapy's relatively lower toxicity when compared to existing treatment standards.
A Step Forward for Cholangiocarcinoma Patients
The results have sparked optimism among the medical community and patients alike. Fiona Garner, Executive Director of Clinical Development at Partner Therapeutics, remarked on the significance of this breakthrough, stating that it emphasizes PTx's commitment to advancing effective therapies for patients facing serious health conditions, particularly those with NRG1 fusion-positive cholangiocarcinoma, a group that has faced limited treatment options and dire prognoses historically.
Additionally, Dr. James M. Cleary, Director of Clinical Research at Dana-Farber Cancer Institute, emphasizes the importance of thorough molecular testing to ensure patients receive appropriate therapy suited to their genetic profiles.
Broader Implications of BIZENGRI
Initially approved in 2024 for advanced non-small cell lung cancer and pancreatic adenocarcinoma with NRG1 gene fusion, BIZENGRI's recent approval for cholangiocarcinoma reflects its potential to change the landscape of treatment in solid tumors harboring this particular gene anomaly. Crucially, zenocutuzumab has made its way into prominent clinical practice guidelines, emphasizing its recognized importance in oncology.
Cholangiocarcinoma itself is recognized as an aggressive cancer with a grim five-year survival rate of less than 15%. Given that NRG1 gene fusions happen in less than 1% of cases, the approval of therapies like zenocutuzumab could potentially offer new hope to patients previously left without effective options.

Conclusion
The publication of the eNRGy trial results in JCO and the subsequent FDA approval of BIZENGRI represent milestones in the evolving narrative of oncology treatments targeting specific genetic mutations. As research continues, the hope is that more patients suffering from rare cancers will gain access to effective therapies, ultimately leading to better outcomes and enhanced quality of life. For more information regarding the eNRGy trial and zenocutuzumab-zbco, visit Partner Therapeutics.

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