Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company announced  that the New England Journal of Medicine (NEJM) published results of the 204-patient, global, multicenter, single-arm, Phase 2 clinical trial of zenocutuzumab-zbco (BIZENGRI^®) (eNRGy trial; NCT02912949).² The eNRGy trial evaluated overall response rate to zenocutuzumab-zbco in patients with NRG1 gene fusions across multiple tumor types. Responses by tumor type and safety data are detailed in the NEJM manuscript.

 "Zenocutuzumab helps fill an important need for patients with advanced pancreatic cancer and NSCLC with NRG1 gene fusions," said Alison Schram M.D., an attending medical oncologist in the Early Drug Development Service at Memorial Sloan Kettering Cancer Center, a principal investigator for the eNRGy trial, and lead author on the NEJM manuscript. "The overall response rate and durability of responses we observed in the eNRGy trial are noteworthy. I strongly encourage my colleagues to obtain tissue-based RNA NGS to identify NRG1 rearrangements and other oncogenic gene alterations, particularly in otherwise driver-negative tumors, as fusions often are missed by DNA-based NGS techniques."

 "The eNRGy study highlights that NRG1 fusions are an actionable therapeutic target and the importance of developing biomarker driven therapies like zenocutuzumab," said Debasish Roychowdhury, MD, Chief Technology Officer at PTx. "We are deeply grateful to the Merus team that designed, researched and developed zenocutuzumab, the eNRGy trial investigators, and the dedicated study participants who helped advance this important research."

 A subset of data from the eNRGy trial reported in the NEJM publication supported the recent FDA approval of BIZENGRI in adult patients with pancreatic adenocarcinoma or NSCLC that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy. These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BIZENGRI^® has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction. See Important Safety Information below.

Under an agreement with Merus, PTx has exclusive rights to develop, manufacture, and commercialize zenocutuzumab-zbco for the treatment of NRG1+ cancer in the U.S. and provide the product on a named-patient basis for this use outside of the U.S. pending future regulatory developments. The companies are working to provide BIZENGRI for commercial distribution as quickly as possible.