Integrated biotechnology company Partner Therapeutics Inc (PTx) reported on Thursday that results from the cholangiocarcinoma cohort of the eNRGy trial have been published in the Journal of Clinical Oncology (JCO).

According to PTx, the data supported the recent US Food and Drug Administration (FDA) approval of BIZENGRI (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harbouring an NRG1 gene fusion with disease progression on or after prior systemic therapy.

The approval was expedited by PTx's receipt of a Commissioner's National Priority Voucher (CNPV) underscoring the urgent unmet need in this patient population.

The eNRGy trial is a multicentre, open-label, phase 2 study evaluating zenocutuzumab in adults with advanced solid tumours harbouring NRG1 gene fusions. Data published in JCO include 22 patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma, of whom 19 were evaluable for efficacy.

The investigator-assessed overall response rate (ORR), defined as the proportion of patients with tumour shrinkage or disappearance, was 36.8%. Median duration of response was 7.4 months, and median progression-free survival was 9.2 months. The clinical benefit rate was 57.9%, defined as the percentage of patients achieving a complete or partial response or stable disease lasting longer than 6 months. Zenocutuzumab was generally well tolerated and no patients discontinued treatment due to treatment-related adverse events.