The EA61411 study conducted by ECOG-ACRIN Cancer Research Group has begun its phase III portion.
Partner Therapeutics Inc. sponsors the study.
EA6141 (NCT02339571) is a randomized controlled study of Leukine (sargramostim, yeast derived rhu-GM-CSF) in combination with ipilimumab and nivolumab for the front line treatment of melanoma.
The restart was based on results of ECOG-ACRIN’s planned interim efficacy and safety analysis of survival data from the first 250 patients enrolled in the study. FDA granted orphan drug status to Leukine in Sept. 2019, for the potential treatment of stage IIb-IV melanoma.
EA61411 is led by study chair F. Stephen Hodi, director of the Center for Immuno-Oncology at Dana-Farber Cancer Institute and study Co-Chair Ahmad Tarhini, professor of oncologic sciences and director of Cutaneous and Clinical Translational Research at H. Lee Moffitt Cancer Center and Research Institute.
“GM-CSF has unique immunomodulatory properties that have the potential to substantially benefit patients with cancer,” Hodi said in a statement. He added “This study in the front line setting is intended to confirm and broaden the findings in the randomized phase II trial EA1608, which demonstrated improved efficacy and toxicity when sargramostim was added to ipilimumab.”
ECOG-ACRIN launched the phase II/III EA6141 study in Sept. 2015. In the study, patients with stage III/IV unresectable melanoma are randomized to receive standard of care treatment with nivolumab and ipilimumab with or without sargramostim. The primary endpoint is overall survival. ECOG-ACRIN planned for the interim trial pause after 240 patients were enrolled, to assess efficacy.
The group paused enrollment in June 2017 and the interim analysis is now complete. Based on the findings of the interim analysis, the ECOG-ACRIN Data Safety Monitoring Committee has given the go ahead to start the enrollment into the phase III portion of the study. The total planned enrollment is 600 patients. The study remains blinded and no data will be released until completion.
“The prior data with sargramostim supporting improvement in survival and reduction in immune-related toxicity, as observed in the E1608 study, highlights the importance of further clinical evaluation in combination with checkpoint inhibitors,” Tarhini said in a statement.
ECOG-ACRIN previously reported results of Study E1608, a phase II study in which patients with advanced stage melanoma received a combination of sargramostim and ipilimumab or ipilimumab alone2. Among 245 patients, the addition of sargramostim led to longer survival (median 17.5 vs 12.7 months, HR 0.64).
Leukine is not approved for the treatment of melanoma.