Merus announces Zeno interim data from Phase 1/2 eNRGy trial

Merus announced interim clinical data, as of a July 31, 2023 data cutoff date, from the phase 1/2 eNRGy trial and Early Access Program of the bispecific antibody zenocutuzumab in patients with neuregulin 1 fusion cancer presented by Principal Investigator, Dr. Alison Schram* of Memorial Sloan Kettering Cancer Center at the European Society for Medical Oncology, ESMO, Congress 2023. Observations in the presentation include: As of July 31, 2023 data cutoff date, 105 patients with NRG1+ NSCLC were treated with Zeno. 78 patients with measurable disease were treated by February 13, 2023, allowing for the potential for greater than or equal to 24 week follow-up, and who met the criteria for the primary analysis population. 37.2% overall response rate per RECIST v1.1 by investigator assessment; 61.5% clinical benefit rate; 14.9 months median duration of response and 20 of patients were continuing treatment as of the data cutoff; Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive pancreatic ductal adenocarcinoma. Observations in the presentation include: As of July 31, 2023 data cutoff date, 44 patients with NRG1+ PDAC were treated with Zeno. 33 patients with measurable disease were treated by February 13, 2023, allowing for the potential for greater than or equal to 24 weeks follow-up, and who met the criteria for the primary analysis population. 42.4% ORR per RECIST v1.1 by investigator assessment; 1 patient achieved a complete response, and 13 patients achieved a partial response; 72.7% clinical benefit rate; 82% experienced tumor reduction; Of 21 patients evaluable for CA 19-9 levels, 78% showed a greater than or equal to 50% decrease in CA 19-9 values from baseline; 9.1 months median DOR; and 6 patients were continuing treatment as of the data cutoff. Safety findings from both presentations: Zeno demonstrated a well-tolerated safety profile among the 189 NRG1+ cancer patients who were treated with 750 mg Q2W monotherapy, with only 6% of patients experiencing related grade 3-4 toxicities.