Merus gets FDA approval of BIZENGRI in NRG1+ Pancreatic Adenocarcinoma, NSCLC

The company states: “Merus (MRUS) announced that the FDA approved BIZENGRI(R) (zenocutuzumab-zbco), the first and only treatment indicated for adults with pancreatic adenocarcinoma or non-small cell lung cancer, 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 and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BIZENGRI(R) has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions, hypersensitivity and anaphylactic reactions, interstitial lung disease/pneumonitis, and left ventricular dysfunction. We believe this approval fills an important need for patients with NRG1+ cancer who have not previously had treatment options approved to specifically target this driver. BIZENGRI(R) (zenocutuzumab-zbco) 20 mg/mL Injection for Intravenous Use is expected to be available to patients in the coming weeks. The approval of BIZENGRI(R) is based on data from the eNRGy trial, a multicenter, open-label clinical trial that enrolled patients with NRG1+ pancreatic adenocarcinoma or NRG1+ NSCLC that is advanced unresectable or metastatic and had disease progression on or after prior systemic therapy. In patients with NRG1+ pancreatic adenocarcinoma, BIZENGRI(R) demonstrated an ORR of 40% (95% CI, 23%-59%). DOR in NRG1+ pancreatic adenocarcinoma ranged from 3.7 months to 16.6 months. In the same trial, patients with NRG1+ NSCLC (n=64) who were treated with BIZENGRI(R) demonstrated an overall response rate of 33%. The median DOR in NRG1+ NSCLC was 7.4 months (95% CI, 4.0-16.6). Response rates were measured using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review. In the pooled safety population (N=175), the most common (greater than or equal to10%) adverse reactions were diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions (IRR), dyspnea, rash, constipation, vomiting, abdominal pain, and edema. The most common Grade 3 or 4 laboratory abnormalities (greater than or equal to2%) were increased gamma-glutamyltransferase, decreased hemoglobin, decreased sodium, decreased platelets, increased aspartate aminotransferase, increased alanine aminotransferase, increased alkaline phosphatase, decreased magnesium, decreased phosphate, increased activated partial thromboplastin time, and increased bilirubin.”