Zenocutuzumab

FDA granted accelerated approval to zenocutuzumab (Bizengri) for NRG1 gene fusion-positive pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC). The therapy targets HER2 and HER3, addressing advanced, unresectable, or metastatic disease that progressed on prior systemic therapy. Results from the eNRGy study showed a third of NSCLC patients and 40% of pancreatic cancer patients responded, with median duration of response of 7.4 months and 3.7 to 16.6 months, respectively. Common adverse events included diarrhea, musculoskeletal pain, and fatigue.

FDA approves zenocutuzumab-zbco for NRG1 fusion-positive NSCLC and pancreatic adenocarcinoma, based on eNRGy trial results showing ORRs of 33% and 40% respectively, with common adverse effects including increased gamma-glutamyl transferase and decreased hemoglobin.

The FDA approved zenocutuzumab-zbco (Bizengri) for advanced NSCLC and pancreatic adenocarcinoma with NRG1 gene fusion, based on the eNRGy trial showing ORR of 33% in NSCLC and 40% in pancreatic adenocarcinoma. Common adverse effects included diarrhea, musculoskeletal pain, and fatigue.

FDA approves zenocutuzumab for NRG1+ NSCLC and PDAC, supported by phase 1/2 eNRGy trial. It's the first targeted therapy for these cancers, with ORR of 33% in NSCLC and 40% in PDAC.

Canaccord Genuity analyst John Newman maintains a Buy rating on Merus (MRUS) stock, citing the strategic partnership with Partner Therapeutics to commercialize Zenocutuzumab in the US. This collaboration allows Merus to focus on petosemtamab, with Zenocutuzumab's potential US approval and manufacturing issues resolution supporting a positive outlook. Newman sets a $67 price target.

Novocure's electrical field-emitting device in Phase 3 trial showed extended survival in pancreatic cancer patients when used with chemo; Merus licensed U.S. rights of its cancer drug zenocutuzumab to Partner Therapeutics; FDA to decide on Cytokinetics' heart drug aficamten approval by Sept. 26, 2025; FDA investigates blood cancer cases post-Bluebird bio's Skysona treatment; Fate Therapeutics' CEO Scott Wolchko to retire, with Bob Valamehr taking over in 2025.

November 2024 saw numerous FDA approvals, designations, and clinical trial advancements in oncology, including revumenib for KMT2A-rearranged acute leukemia, obe-cel for relapsed/refractory B-cell ALL, and fast track designations for ALE.P02 in Claudin-1-positive tumors. Other highlights include orphan drug designations for LBL-024 in neuroendocrine cancer and elraglusib in Ewing sarcoma, and a new drug application for sunvozertinib in EGFR-mutant NSCLC.

Lung cancer, primarily non-small cell lung cancer (NSCLC), is a leading cause of morbidity and mortality globally. Targeted therapies have emerged as a preferred first-line treatment for NSCLC patients with oncogenic driver mutations, such as EGFR, ALK, ROS1, BRAF, MET, RET, FGFR, and NTRK. These therapies, including small-molecule drugs and monoclonal antibodies, have shown superior efficacy compared to traditional chemotherapy and immunotherapy, particularly in specific molecular subtypes. Challenges remain in drug resistance, adverse effects, and determining optimal treatment sequences. Continued research is essential for advancing precision medicine in lung cancer treatment.

FDA extends review of Merus' bispecific antibody zenocutuzumab, targeting non-small cell lung cancer and pancreatic ductal adenocarcinoma with specific genetic mutations, due to additional CMC information submission. New action date set for Feb. 4, 2025. No clinical data issues identified. Zenocutuzumab disrupts HER2 and HER3 binding to inhibit cancer cell proliferation. Merus also developing petosemtamab for head and neck squamous cell carcinoma and metastatic colorectal cancer.

The FDA extended the PDUFA target action date for zenocutuzumab's BLA to February 4, 2025, for NRG1+ NSCLC and pancreatic cancer. Priority review was granted in May 2024, with additional time needed for chemistry, manufacturing, and controls assessment.