An Independent Data Monitoring Committee recommended the trial be stopped because of lack of survival benefit for patients receiving the drug compared to placebo.
AbbVie announced that it has halted its Phase III INTELLANCE-1 clinical trial of depatuxizumab mafodotin (Depatux-M) in patients with newly diagnosed glioblastoma (GBM) whose tumors have epidermal growth factor receptor (EGFR) amplification. An Independent Data Monitoring Committee (IDMC) recommended the trial be stopped because of lack of survival benefit for patients receiving the drug compared to placebo.
The trial compared the efficacy and safety of Depatux-M compared to placebo when given with concurrent radiation and temozolomide and with adjuvant temozolomide in patients with newly diagnosed EGFR-amplified GBM. The primary endpoint was overall survival (OS). The interim analysis was based on data from 639 patients.
According to the American Cancer Society, about 17,760 people are estimated to die from brain and spinal cord tumors in the U.S. in 2019. Glioblastoma, or glioblastoma multiforme (GBM), are usually found in the cerebral hemispheres of the brain but can be found anywhere. They are malignant grade IV tumors, where much of the tumor cells reproduce and divide at any given time, according to the American Brain Tumor Association. With standard treatments, median survival for adult glioblastoma, IDH-wildtype, is about 11 to 15 months.
Glioblastoma is the type of aggressive cancer that took the life of the late Senator John McCain in 2017.
“Glioblastoma patients and their caregivers face a devastating disease for which there are few therapeutic options,” stated Michael Severino, vice chairman and president of AbbVie. “While we are disappointed that Depatux-M did not demonstrate a survival benefit in the INTELLANCE-1 study, we remain committed to discovering and developing therapies to address some of the most debilitating cancers.”
The trial was conducted in collaboration with the RTOG Foundation. “The highly collaborative partnership between RTOG Foundation’s scientific and physician leaders, under the leadership of Andrew Lassman, MD, the study principal investigator, and the AbbVie team facilitated the early completion of this important international clinical trial,” stated Walter J. Curran Jr., RTOG Foundation board chair and executive director of the Winship Cancer Institute of Emory University. “The RTOG Foundation’s outstanding glioblastoma experts will continue to vigorously investigate new approaches to this very challenging malignancy.”
Earlier this week, the U.S. Food and Drug Administration (FDA) approved AbbVie’s Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venclexta is an oral B-cell lymphoma-2 (BCL-2) inhibitor, which has been granted five Breakthrough Therapy designations by the FDA.
“Patients never treated for their CLL have had to rely largely on chemotherapy as their initial treatment,” stated Michael Hallek, lead investigator of the CLL14 study, Department of Internal Medicine and Center of Integrated Oncology at the University Hospital Cologne in Germany and Head of the Germany CLL Study Group. “The approval of Venclexta combination means that patients with previously untreated CLL now have a finite duration, chemotherapy-free treatment option that can allow them to live longer without disease progression, induce high rates of minimal residual disease (MRD) negativity, and, importantly, allow them to complete their course of therapy within 12 months.”
