Efficacy of Zenocutuzumab in <i>NRG1</i> Fusion–Positive Cancer
Alison M. Schram, Kōichi Goto, Dong-Wan Kim, Teresa Macarulla, Antoine Hollebecque, Eileen M. O’Reilly, Sai‐Hong Ignatius Ou, Jordi Rodón, Sun Young Rha, Kazumi Nishino, M. Duruisseaux, Joon Oh Park, Cindy Neuzillet, Stephen V. Liu, Benjamin A. Weinberg, James M. Cleary, Emiliano Calvo, Kumiko Umemoto, Misako Nagasaka, Christoph Springfeld, Tanios Bekaii‐Saab, Grainne M. O’Kane, Frans L. Opdam, Kim A. Reiss, Andrew K. Joe, Ernesto Wasserman, Viktoriya Stalbovskaya, Jim Ford, Shola Adeyemi, Lokesh Jain, Shekeab Jauhari, Alexander Drilon
Abstract
BACKGROUND: fusion-positive solid tumors are unclear. METHODS: fusion-positive cancer involving any tumor type to receive zenocutuzumab at a dose of 750 mg intravenously every 2 weeks. The primary end point was overall response (complete or partial response) according to investigator assessment. Secondary end points included duration of response, progression-free survival, and safety. RESULTS: fusion partners. The median progression-free survival was 6.8 months (95% CI, 5.5 to 9.1). Adverse events were primarily grade 1 or 2. The most common adverse events that were considered by the investigator to be related to zenocutuzumab were diarrhea (in 18% of the patients), fatigue (in 12%), and nausea (in 11%). Infusion-related reactions (composite term) were observed in 14% of the patients. One patient discontinued zenocutuzumab owing to a treatment-related adverse event. CONCLUSIONS: fusion-positive cancer, notably NSCLC and pancreatic cancer, with mainly low-grade adverse events. (Funded by Merus; eNRGy ClinicalTrials.gov number, NCT02912949.).