Statement on Discontinued Development of Brigimadlin

In light of the recent online discussions about brigimadlin, we would like to briefly recap the key information we shared a few weeks ago regarding SPAGN’s engagement in exploring the potential continuation of the drug’s development.

We hope this summary helps you provide accurate information should any questions arise within your organizations or institutions.

Here is an overview of what has happened so far:

• The phase III trial of brigimadlin in dedifferentiated liposarcoma did not meet its primary endpoint. The data were presented at CTOS in November 2024.
• After reviewing the results with leading sarcoma experts and consulting regulatory authorities (e.g. FDA) to explore potential paths forward, Boehringer Ingelheim decided to end further development of brigimadlin in early 2025.
• Because of the hope this drug represented for members of our community, SPAGN engaged in several months of in-depth discussions with Boehringer Ingelheim. These meetings included representatives from multiple departments - senior leadership in R&D (Oncology), Medical Affairs, and Patient/Commercial Engagement—and focused on exploring potential paths forward. Our concerns were reviewed and discussed by the company’s top leadership.
• However, despite all efforts, in late July Boehringer Ingelheim’s leadership confirmed the final decision to discontinue the development of brigimadlin for all indications. We were advised by the company representatives that they had thoroughly evaluated the possible options based on our discussions before reaching their decision.

This outcome is, of course, very disappointing. After carefully evaluating all possible options to advocate for continued development, the SPAGN Board and the Executive Director concluded that no further advocacy action at this time would change the current situation.

We continue to maintain an open dialogue with the company and will monitor for new developments or reconsideration of their position. We will keep you informed of any new updates.

We sincerely thank everyone — both globally and in the US — among the sarcoma experts and within our sarcoma patient community who invested significant time and effort together with SPAGN in this process.

Please feel free to contact us with any questions.

With appreciation for all that you do,

The SPAGN Board of Directors, Executive Director and Team