Brightline-1 trial launch in rare sarcoma

Mehdi Lahmar, Clinical Program Leader in Oncology at Boehringer Ingelheim discusses the role that our MDM2-p53 antagonist plays in rare types of soft tissue sarcoma and the launch of the Brightline-1 clinical trial.

Dedifferentiated liposarcoma, or DDLPS, is a rare and aggressive form of sarcoma with a poor prognosis. Patients impacted by this devastating cancer have had no new first-line treatment options in 45 years. For this reason, it’s an exciting moment to share that the first patient has been enrolled at UZ Leuven (Belgium) by Patrick Schöffski’s team in our clinical trial called Brightline-1 (ClinicalTrials.gov Identifier: NCT05218499), studying an investigational treatment option for patients with advanced DDLPS. This compound is an investigational agent and has not been approved for use. The efficacy and safety of this investigational compound have not been established.

Brightline-1, a Phase II/III, randomized, open-label, multi-center study, investigates brigimadlin (BI 907828, an oral, small molecule MDM2-p53 antagonist) compared to doxorubicin as a first-line treatment for patients with advanced DDLPS. Approximately 300 patients are planned to be enrolled in the study globally with sites across Europe, North America and Asia.

Through this trial and other upcoming ones, and in partnership with experts in this field, we intend to expand our knowledge, and that of the medical community, about the role of the MDM2-p53 pathway in cancer development. This pathway is an area of high interest for the medical community as approximately 5-7% of tumors display MDM2 amplifications, including lung cancer and other malignancies, with an incidence of up to 90% in some types of soft tissue sarcoma (STS).

Our goal is to transform the lives of people with cancer by delivering medical innovations in areas of high unmet need. Boehringer Ingelheim is committed to pioneering treatment advancements in some of the most challenging and most impactful areas of cancer.

Our rich pipeline of next-generation oncology treatments is comprised of cancer cell-directed and immuno-oncology therapies, the smart combinations of which may hold the greatest benefit for most patients. We proactively collaborate with patients, advocacy organizations, and the world’s leading academic centers and industry, because we believe together, we can make a bigger impact in transforming the lives of people with cancer.

We hope the results of this clinical trial will provide sarcoma specialists with more therapeutic options that ultimately improve the lives of patients with DDLPS.