Merck KGaA Updates on Phase III TrilynX Study in Head and Neck Cancer

DARMSTADT, Germany--Merck KGaA, Darmstadt, Germany, a prominent science and technology firm, has announced the termination of its Phase III TrilynX study. This research aimed to evaluate the efficacy of xevinapant combined with chemoradiotherapy (CRT) for patients suffering from unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). The decision followed a pre-scheduled interim analysis by an Independent Data Monitoring Committee, which concluded that the trial was unlikely to achieve its primary goal of extending event-free survival. Although primary safety data were consistent with the chemo-radio sensitizing characteristics of xevinapant, the company will perform a comprehensive data review and release the findings in a peer-reviewed setting.

LA SCCHN continues to be a challenging cancer type to treat. Despite being the standard treatment for decades, CRT has not seen significant improvements in outcomes, even with various studies exploring new treatment methodologies, including multiple immunotherapy trials.

Danny Bar-Zohar, the Global Head of Research & Development and Chief Medical Officer of Merck KGaA, Darmstadt, Germany, expressed gratitude to those involved in the study, including patients, caregivers, and clinical investigators. Bar-Zohar acknowledged the disappointment in the trial's results but reaffirmed the company’s dedication to developing groundbreaking medicines for areas with significant unmet medical needs within its oncology portfolio.

Given the overall data, Merck KGaA, Darmstadt, Germany also decided to halt the Phase III X-Ray Vision clinical trial. This trial was comparing the effects of xevinapant plus radiotherapy against a placebo plus radiotherapy in patients who had undergone resection for locally advanced head and neck cancer.

Merck KGaA, Darmstadt, Germany is actively engaged in developing new treatments that target tumor vulnerabilities. The company is investigating various modalities, such as antibody-drug conjugates (ADCs) and DNA damage response (DDR) inhibitors across multiple cancer types, especially those with significant unmet needs. The company remains committed to supporting the head and neck cancer community, particularly through Erbitux®. Erbitux is commercially available outside the U.S. and Canada and is approved in Europe for use in combination with radiotherapy for treating locally advanced SCCHN. Currently, Erbitux is involved in over 200 active clinical trials, including at least 15 Phase III studies.

Xevinapant, initially known as Debio 1143, is an investigational oral small-molecule inhibitor of apoptosis protein (IAP). In March 2021, Merck KGaA, Darmstadt, Germany, acquired exclusive global rights from Debiopharm International SA to develop and commercialize xevinapant. As of now, xevinapant is not approved for use anywhere in the world.

Merck KGaA, Darmstadt, Germany is committed to advancing cancer care. The company’s research is focused on exploring promising cancer mechanisms and synergistic approaches to target cancer at its core. The goal is to maximize the impact of current treatments and develop innovative medicines, with the vision of turning more cancer patients into survivors.

Merck KGaA, Darmstadt, Germany operates across life sciences, healthcare, and electronics, employing around 63,000 people worldwide. In 2023, the company reported sales of €21 billion across 65 countries. Globally recognized for their trademark “Merck,” the company operates under different names in the U.S. and Canada. Since its establishment in 1668, Merck KGaA, Darmstadt, Germany, has been driven by scientific exploration and responsible entrepreneurship, with the founding family still holding the majority ownership.

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