Efficacy of Zenocutuzumab in NRG1 Fusion-Positive Cancer.
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Schram Alison M, Goto Koichi, Kim Dong-Wan, Macarulla Teresa, Hollebecque Antoine, O'Reilly Eileen M, Ou Sai-Hong Ignatius, Rodon Jordi, Rha Sun Young, Nishino Kazumi, Duruisseaux Michaël, Park Joon Oh, Neuzillet Cindy, Liu Stephen V, Weinberg Benjamin A, Cleary James M, Calvo Emiliano, Umemoto Kumiko, Nagasaka Misako, Springfeld Christoph, Bekaii-Saab Tanios, O'Kane Grainne M, Opdam Frans, Reiss Kim A, Joe Andrew K, Wasserman Ernesto, Stalbovskaya Viktoriya, Ford Jim, Adeyemi Shola, Jain Lokesh, Jauhari Shekeab, Drilon Alexander, eNRGy Investigators
Аннотация
METHODS: In this registrational, phase 2 clinical study, we assigned patients with advanced NRG1 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: A total of 204 patients with 12 tumor types were enrolled and treated. Among 158 patients who had measurable disease and were enrolled at least 24 weeks before the data-cutoff date, a response occurred in 30% (95% confidence interval [CI], 23 to 37). The median duration of response was 11.1 months (95% CI, 7.4 to 12.9); 19% of responses were ongoing at the data-cutoff date. Responses were observed in multiple tumor types - including in 27 of 93 patients (29%; 95% CI, 20 to 39) with non-small-cell lung cancer (NSCLC) and 15 of 36 patients (42%; 95% CI, 25 to 59) with pancreatic cancer - and across multiple NRG1 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: Zenocutuzumab showed efficacy in patients with advanced NRG1 fusion-positive cancer, notably NSCLC and pancreatic cancer, with mainly low-grade adverse events. (Funded by Merus; eNRGy ClinicalTrials.gov number, NCT02912949.).