Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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Bristol-Myers Squibb Company (BMY) has announced a new clinical study, titled ‘A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer.’ The study aims to evaluate the efficacy and safety of a novel bi-specific antibody-drug conjugate, iza-bren, in patients with specific types of breast cancer who are not eligible for certain other treatments. This study is significant as it targets a challenging patient population with limited treatment options.
The intervention being tested is iza-bren, a bi-specific antibody-drug conjugate designed to target EGFR and HER3, combined with a topoisomerase inhibitor. This drug aims to provide a new treatment avenue for patients with triple-negative breast cancer (TNBC) or ER-low, HER2-negative breast cancer.
The study follows an interventional design, with participants randomly allocated to receive either iza-bren or a treatment of the physician’s choice. The model is parallel, with no masking, and the primary purpose is treatment. This straightforward design allows for a direct comparison of the new drug against existing treatments.
The study is set to begin on July 15, 2025, with an estimated primary completion date yet to be announced. The last update was submitted on June 24, 2025. These dates are crucial as they mark the progress and timeline of the study, which is not yet recruiting participants.
This clinical update could potentially impact Bristol-Myers Squibb’s stock performance positively, as successful trials may lead to a new marketable treatment, enhancing the company’s portfolio. Investors should watch for developments, especially considering the competitive landscape in oncology treatments.
The study is ongoing, with further details available on the ClinicalTrials portal.