Drs. Adel Shahnam and Mrinal M. Gounder (sarcoma oncologists/researchers from Memorial Sloan Kettering Cancer Center) published an article highlighting the potentially positive findings from the BRIGHTLINE-1 trial. Although Boehringer Ingelheim considered the trial unsuccessful because it did not meet its primary endpoint and subsequently discontinued the program, the authors point to important results that show meaningful activity and deserve further consideration.
This article takes a closer look at the BRIGHTLINE-1 trial and argues that, although the study did not meet its main goal, the results still showed that brigimadlin has meaningful activity against dedifferentiated liposarcoma (DDLPS). Patients receiving brigimadlin went a median of 8.4 months without their cancer getting worse, and about 22% had their tumors shrink. The authors suggest the trial may have been considered “negative” partly because doxorubicin, the treatment it was compared with, worked better than researchers had expected. Rather than showing that brigimadlin does not work, they believe the study provides evidence that both drugs are active treatments and that brigimadlin deserves further study for people with DDLPS.
The development of new treatment options and continued advancement of research for people living with liposarcoma is critical, particularly given the limited therapies currently available and high unmet need for therapies that improve outcomes that are directly meaningful to patients. At the same time, we believe clinical trial designs should maximize patient access to the active treatment whenever possible, especially in the context of this rare and aggressive cancer that is associated with poor prognosis. We also believe that appropriate comparators are essential for demonstrating meaningful clinical benefit on endpoints such as survival and disease control. Patients deserve opportunities to participate and benefit from promising new therapies and research approaches should carefully balance scientific rigor with the urgent unmet needs of those facing serious debilitating and life-threatening diseases where time is a particularly precious resource.
Read the full article via the PDF on this page.
To support a new trial to investigate brigimadlin as a option for patients with dedifferentiated liposarcoma, please sign the petition today.