#United States #Lexington #BIZENGRI #Partner Therapeutics #NRG1 Fusion

Partner Therapeutics Advances Cancer Treatment with BIZENGRI Submission

LEXINGTON, Mass., April 14, 2026 /PRNewswire/ – Partner Therapeutics, Inc., a fully integrated biotechnology firm, has taken a monumental step in oncology by submitting a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for its innovative treatment, BIZENGRI (zenocutuzumab-zbco). This application aims to extend the FDA’s approval for the treatment of adults diagnosed with advanced unresectable or metastatic cholangiocarcinoma that harbors a neuregulin 1 (NRG1) gene fusion, a rare and aggressive form of cancer affecting the bile ducts.

Cholangiocarcinoma poses considerable challenges due to its rarity and lack of effective treatment options, especially for patients with NRG1 gene fusions. As noted by Pritesh J. Gandhi, the Chief Development Officer at Partner Therapeutics, "This submission represents a significant advancement for patients suffering from NRG1 fusion-positive cholangiocarcinoma, a group that has historically faced dismal outcomes with current therapies."

The sBLA is substantiated by promising data derived from the eNRGy study, which investigates the efficacy of zenocutuzumab-zbco across various cancer types, including cholangiocarcinoma. In a specific cohort of cholangiocarcinoma patients, BIZENGRI achieved an overall response rate (ORR) of 36.8% along with a median duration of response (DOR) of 12.9 months according to blinded independent central review (BICR). Importantly, the treatment exhibited an acceptable safety profile, without any patients having to discontinue due to adverse reactions.

Following these encouraging results, the National Comprehensive Cancer Network® (NCCN®) recognized zenocutuzumab-zbco by incorporating it into the updated Oncology Clinical Practice Guidelines for biliary tract cancers. It has been designated as a Category 2A subsequent-line therapy along with a Category 2B recommendation for first-line treatment of cholangiocarcinoma associated with NRG1 fusions.

Dr. James Cleary from the Dana-Farber Cancer Institute emphasized the significance of identifying NRG1 gene fusions, which have emerged as actionable biomarkers in the context of cholangiocarcinoma treatment. He stated, "The data from the eNRGy study indicate that targeting these fusions with zenocutuzumab might offer a meaningful therapeutic avenue for patients confronting this challenging disease."

BIZENGRI is not limited to cholangiocarcinoma; it also has previously received FDA accelerated approval for treating advanced unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma patients with NRG1 gene fusions, who have shown disease progression following previous systemic therapies. The company remains committed to ensuring the development of robust treatments that address significant unmet medical needs within oncology and serious diseases.

With BIZENGRI poised to transform the landscape of therapeutic options for cholangiocarcinoma, Partner Therapeutics is optimistic about the response from the FDA and the ongoing support of the medical community. They are dedicated to leveraging their expertise in biotechnology to yield improved outcomes for patients battling these severe conditions.

For further information regarding the eNRGy trial and zenocutuzumab-zbco, interested parties are encouraged to visit the official website of Partner Therapeutics: www.partnertx.com.

About Partner Therapeutics

Partner Therapeutics, Inc. focuses on the development and commercialization of therapeutics aimed at improving health outcomes for patients with cancer and serious diseases. Their product portfolio includes BIZENGRI (zenocutuzumab-zbco) and sargramostim (EU IMREPLYS®; US LEUKINE®), both geared towards advancing the treatment paradigm in their respective fields.