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  • Merus (MRUS) Gains Extended-Session Momentum On Trial News

    Merus (MRUS) Gains Extended-Session Momentum On Trial News

    Following the announcement of positive interim clinical trial data, Merus N.V. (NASDAQ: MRUS) shares jumped 15.12% in the after-market session on Thursday, trading at $47.89.

    Promising Outcomes Ahead of ASCO Presentation

    Progress from the current Phase 2 study assessing the bispecific antibody petosemtamab in conjunction with pembrolizumab was revealed by Merus (MRUS). The findings, which are based on data gathered until February 27, 2025, have greatly boosted investor confidence. Dr. Carla M. L. van Herpen of Radboud University Medical Center will discuss the clinical results at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2.

    Merus claims that the combo treatment has performed better on a number of effectiveness measures than pembrolizumab monotherapy, which is now the control arm in its Phase 3 study. These findings demonstrate how petosemtamab may be able to change the accepted practice for treating head and neck squamous cell carcinoma (HNSCC), a disease with a high death rate and poor prognoses.

    Key Trial Metrics and Patient Response

    Of the 45 patients enrolled in the interim Phase 2 trial, 43 were eligible for an effectiveness evaluation at the time of the data cutoff. According to RECIST v1.1 criteria, Merus reported an overall response rate of 63% among them, comprising six full and 21 partial replies.

    Additional analyses conducted on both first-line and second-line therapy groups supported these findings. Interestingly, individuals who had never smoked accounted for a sizable percentage of verified responses in HPV-associated p16+ oropharyngeal cancer, indicating possible biological significance in this cohort.

    Looking Ahead to Phase 3 Milestones

    Merus has demonstrated swift clinical execution with rapid site activation for its trials and anticipates releasing top-line interim results from one or both Phase 3 studies by 2026. MRUS also held a conference call and webcast on Thursday to further elaborate on these results and its future development roadmap.

  • Merus (MRUS) Stock Surge Following Abstract Publication News

    Merus (MRUS) Stock Surge Following Abstract Publication News

    The publication of an abstract detailing pivotal clinical trial data has significantly boosted the stock price of Merus N.V. (NASDAQ: MRUS) by 36.12% to conclude the weekend session at $59.99.

    Abstract Publication And Conference Call Announcement

    Merus (MRUS) announced the availability of an abstract on the American Society of Clinical Oncology (ASCO) Annual Meeting website for 2024 that discusses petosemtamab and pembrolizumab combination treatment.

    In order to assess the combination’s effectiveness in first-line (1L) recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC), this presentation provides early clinical data from a cohort of 26 patients enrolled before the cutoff date.

    Given the low frequency of Grade 3 or higher adverse events and the few infusion-related responses, Merus has expressed confidence about the combination’s safety and effectiveness.

    Promising Early Results And Anticipated Mature Data

    Despite the early cutoff date, the abstract data indicate promising efficacy. Merus is particularly encouraged by the combination therapy’s tolerability and safety profile, highlighting the potential for petosemtamab to set a new standard in head and neck cancer treatment.

    The interim data will be further elaborated upon in the upcoming conference call, where more mature clinical updates, showing an improved response rate, will be discussed.

    Clinical Observations And Adverse Event Profile

    The observations as of the November 6, 2023 data cutoff include:

    • A total of 26 patients treated, with 24 continuing therapy.
    • Of the 10 evaluable patients, 6 exhibited responses: 1 confirmed complete response, 2 confirmed partial responses, and 3 unconfirmed partial responses according to the Response Evaluation Criteria in Solid Tumors v1.1.

    Overall, the combination treatment was well tolerated, and no notable overlapping toxicities were noted. All patients experienced treatment-emergent adverse events, most of which were of Grade 1 or 2 severity. Just 3.8% of patients experienced Grade 3 responses, which were completely cured after the first infusion. In total, 26.9% of patients had reactions associated to infusions.

    This encouraging early data positions Merus’ combination therapy as a potential frontrunner in the treatment of head and neck squamous cell carcinoma, with further insights expected from the detailed discussions at the upcoming ASCO conference.